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Abstract Rift Valley fever (RVF) is a vector‐borne disease transmitted by a broad spectrum of mosquito species, especially Aedes and Culex genus, to animals (domestic and wild ruminants and camels) and humans. Rift Valley fever is endemic in sub‐Saharan Africa and in the Arabian Peninsula, with periodic epidemics characterised by 5–15 years of inter‐epizootic periods. In the last two decades, RVF was notified in new African regions (e.g. Sahel), RVF epidemics occurred more frequently and low‐level enzootic virus circulation has been demonstrated in livestock in various areas. Recent outbreaks in a French overseas department and some seropositive cases detected in Turkey, Tunisia and Libya raised the attention of the EU for a possible incursion into neighbouring countries. The movement of live animals is the most important pathway for RVF spread from the African endemic areas to North Africa and the Middle East. The movement of infected animals and infected vectors when shipped by flights, containers or road transport is considered as other plausible pathways of introduction into Europe. The overall risk of introduction of RVF into EU through the movement of infected animals is very low in all the EU regions and in all MSs (less than one epidemic every 500 years), given the strict EU animal import policy. The same level of risk of introduction in all the EU regions was estimated also considering the movement of infected vectors, with the highest level for Belgium, Greece, Malta, the Netherlands (one epidemic every 228–700 years), mainly linked to the number of connections by air and sea transports with African RVF infected countries. Although the EU territory does not seem to be directly exposed to an imminent risk of RVFV introduction, the risk of further spread into countries neighbouring the EU and the risks of possible introduction of infected vectors, suggest that EU authorities need to strengthen their surveillance and response capacities, as well as the collaboration with North African and Middle Eastern countries.

The systematic monitoring of health indicators has the potential to complement conventional (confirmation‐based) surveillance systems, by extracting value from already existing data. A working group (WG) of experts on syndromic and early warning surveillance was formed by EFSA in May 2020 and tasked to develop and test prototype early‐warning animal health surveillance systems covering the wider European region. The first successful pilot of the WG, described in this report, focused on the systematic monitoring of indicators of rabies occurrence. The working assumption of this pilot project is that the number of news articles in media referring to rabies would constitute a good indicator for monitoring sudden changes in occurrence and/or risk of rabies cases in neighbouring EU countries. EFSA, and the European Commission's Joint Research Centre (JRC) worked together on developing a user‐friendly interface for the TIM (Tools for Innovation Monitoring) tool, and particularly the TIM NEWS application. An automatic search (across a predefined number of data sources) for rabies‐related news items was already implemented in the tool. This was used to develop a "dashboard" with spatial and temporal visualisation of the results. This open dashboard will enable authorities involved in rabies risk assessment and management to monitor the daily distribution of media articles related to rabies published worldwide, which is assumed to contribute to disease and risk situation awareness. [ABSTRACT FROM AUTHOR]

EFSA received a mandate from the European Commission to assess the risks related to a possible reduction of the waiting period after rabies antibody titration test to 30 days compared with 90 days of the current EU legislation, for dogs moving from certain non‐EU countries to the EU. This Scientific Report assessed the probability of introduction of rabies into the EU through commercial and non‐commercial movements of vaccinated dogs with a positive titration test (≥ 0.5 IU/mL) if the waiting period decreases from 90 to 30 days. Assuming that all the legal requirements are complied with, the risk of transmission of rabies through the movement of a vaccinated dog is related to the risk of introducing an animal incubating rabies that was infected before the day of vaccination or shortly after vaccination but before the development of immunity (21 days post‐vaccination). Using published data on the incubation period for experimental and field cases in dogs and considering the rabies incidence data in certain countries, the aggregated probability for the annual introduction of rabies through dogs was assessed. Considering the uncertainty related to the duration of the incubation period, the number of imported dogs, and the disease incidence in some countries it was concluded with a 95% certainty that the maximum number of rabies‐infected imported dogs complying with the regulations in a 20‐year period could increase from 5 to 20 when decreasing the waiting period from 90 to 30 days. Nevertheless, the potential impact of even a small increase in probability means the risk is increased for a region like the EU where rabies has long been a focus for eradication, to protect human and animal health. [ABSTRACT FROM AUTHOR]

The purpose of this technical report is to present the methodology that will be implemented to address the terms of reference of a mandate received from the European Commission (EC). This mandate requests EFSA to assess the effectiveness of some of the control measures related to Category 'A' diseases. More specifically, in this report EFSA illustrates the methodology to assess the following features: i) the sampling of animals and establishments for the detection of category 'A' diseases in terrestrial animals; ii) the monitoring period; and iii) the minimum radius of restricted zones and duration of the disease control measures in restricted zones. The first step was to understand in detail the request of the EC and the outcome of this exercise is reported in the sections dedicated to the interpretation of the terms of reference. For the identification of the most suitable methodology, specific scenarios were identified, for each measure, to ensure that the approach was able to cover as many situations as possible in the field. Once the approach was identified, it was possible to define the data needs and the potential sources of information. Extensive literature search appeared to be essential to retrieve some of the necessary inputs for some diseases and for some important parameters; for this reason, and in the interest of time, EFSA procured this work by means of a public call. In case the scientific literature will not offer the required information, expert knowledge elicitation will serve the purpose. A section was dedicated to the assessment of the uncertainty. In conclusion, this work represents the general methodological framework underpinning the scientific opinions that will be issued for each category 'A' disease. Any unavoidable deviation from the approach as described here will be duly documented in the scientific opinions [ABSTRACT FROM AUTHOR]

Avian influenza (AI) is a viral infectious disease that affects all species of domestic and wild birds. The viruses causing this disease can be of high (HPAI) or low (LPAI) pathogenicity and represent a continuous threat to poultry in Europe. Council Directive 2005/94/EC requests EU Member States (MSs) to carry out surveillance in poultry and wild birds and notify the results to the responsible authority. Therefore, MSs and Switzerland have implemented surveillance programmes to yearly monitor incursions of AI viruses in poultry and wild birds. EFSA received a mandate from the European Commission, to collate, validate, analyse and summarise in an annual report the data resulting from the avian influenza surveillance programmes. This is the first report produced under this mandate summarising the results of the surveillance activities carried out in poultry and wild birds in 2018. Overall 18,596 poultry establishments were sampled, of which 43 were seropositive for H5 AI and two for H7 AI. Seropositive establishments were found in 11 MSs, with the highest percentage of seropositive establishments being found in waterfowl gamebird, and geese and duck breeding establishments. A total of 9,145 dead/moribund wild birds were sampled, with 163 birds testing positive to HPAI virus H5N6. The infected birds were reported by eight MSs and were mostly found between January and April 2018. In this report, the wild bird species affected with HPAI are described and the strategy of targeted sampling is assessed. The crude odds ratio of HPAI detection as a function of the target species (species belonging to the list of target species versus species not belonging to the target list) is presented. The surveillance findings for poultry and wild birds for 2018 are also discussed in relation to findings from previous years and current knowledge on the epidemiology of AI in Europe. [ABSTRACT FROM AUTHOR]

The most significant knowledge gaps in the prevention and control of African swine fever (ASF) were identified by the EU Veterinary services and other stakeholders involved in pig production and wild boar management through an online survey. The respondents were asked to identify the major research needs in order to improve short‐term ASF risk management. Four major gaps were identified: 'wild boar', 'African swine fever virus (ASFV) survival and transmission', 'biosecurity' and 'surveillance'. In particular, the respondents stressed the need for better knowledge on wild boar management and surveillance, and improved knowledge on the possible mechanism for spread and persistence of ASF in wild boar populations. They indicated the need for research on ASFV survival and transmission from the environment, different products such as feed and feed materials, and potential arthropod vector transmission. In addition, several research topics on biosecurity were identified as significant knowledge gaps and the need to identify risk factors for ASFV entry into domestic pig holdings, to develop protocols to implement specific and appropriate biosecurity measures, and to improve the knowledge about the domestic pig–wild boar interface. Potential sources of ASFV introduction into unaffected countries need to be better understood by an in‐depth analysis of the possible pathways of introduction of ASFV with the focus on food, feed, transport of live wild boars and human movements. Finally, research on communication methods to increase awareness among all players involved in the epidemiology of ASF (including truck drivers, hunters and tourists) and to increase compliance with existing control measures was also a topic mentioned by all stakeholders. [ABSTRACT FROM AUTHOR]

In 2018, no lumpy skin disease (LSD) outbreaks were reported in the Balkan region, after the decline reported in 2017 (385) compared to 2016 (7,483). This confirms the effectiveness of the vaccination campaign based on the LSD homologous vaccine strain which continued throughout 2018 with over 2.5 million animals vaccinated, keeping the mean vaccination coverage above 70%. In 2018, LSD outbreaks were reported in Russia, Turkey and Georgia. In Russia, the LSD epidemics expanded northward and eastward, while in Turkey, the most affected region was in the east. LSD is spreading in Turkey since 2013, despite large vaccination campaigns with heterologous vaccine performed since 2014. This might support the hypothesis that the use of heterologous vaccines results in insufficient protection, and therefore, the use of homologous LSD vaccine in Turkey should be considered to prevent further spread. As the LSD epidemic in Turkey is a risk for reintroduction into the EU, it is recommended to continue the vaccination campaigns in 2019 in the high‐risk areas of Balkan region. Spread rates of LSD within a village were estimated from outbreak data for Albania, which can be used to inform the level of vaccination required to control an outbreak in a village. In terms of vaccine safety, the reports from the field suggest that, compared to the large number of animals vaccinated in the Balkan region since 2015, a very limited number of side effects have been recorded so far, although from published literature, local or even systemic side effects in some animals may occur after vaccination. However, due to inadequate study design in the reviewed studies, there is no consensus on the magnitude of such effects and on their real consequences on production. [ABSTRACT FROM AUTHOR]

The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 4 and 3 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD virus (LSDV). For shorter campaigns, LSD is predicted to persist. When the infection is eliminated by vaccination, two pathways for disease recurrence are possible, (i) by new introduction from a neighbouring affected area, especially by introduction of infected animals, or, less likely (ii) the infection persisting either in the environment, in vectors or in wild animals. For planning surveillance, several elements should be considered: the objectives and related design prevalence, the epidemiological situation, the immunological status of the host population, the geographical area and the season, the type of surveillance (active or passive), the diagnostic methods including clinical detection (considered the most effective method for early detection of LSD), the target population, the sample size and frequency. According to the model, for early detecting new introductions of LSD, it may be needed to clinically check a large number of herds (e.g. 2–3,000 herds) monthly. Lower sample sizes can be considered, when a greater delay in detecting the virus is acceptable. Where vaccination is maintained, active surveillance for verifying the effectiveness of vaccination would be needed. Demonstrating disease absence can rely on serological surveillance, which should consider the test sensitivity, the design prevalence (estimated value: 3.5%), the onset and duration of serum antibodies. Important knowledge gaps on LSD are about within‐herd transmission, duration of protective immunity, role of vectors, diagnostic tests, farm location and type in the at‐risk countries and the epidemiological status of neighbouring countries. [ABSTRACT FROM AUTHOR]

Spring Viraemia of Carp (SVC) was assessed according to the criteria of the Animal Health Law (AHL), in particular the criteria of Article 7 on disease profile and impacts, Article 5 on its eligibility to be listed, Annex IV for its categorisation according to disease prevention and control rules as in Article 9 and Article 8 for listing animal species related to SVC. The assessment was performed following the ad hoc method for data collection and assessment previously developed by the AHAW panel and already published. The outcome reported is the median of the probability ranges provided by the experts, which indicates whether each criterion is fulfilled (lower bound ≥ 66%) or not (upper bound ≤ 33%), or whether there is uncertainty about fulfilment. Reasoning points are reported for criteria with an uncertain outcome. According to the assessment performed here, it is uncertain whether SVC can be considered eligible to be listed for Union intervention according to Article 5 of the AHL (45-90% probability). According to the criteria in Annex IV, for the purpose of categorisation related to the level of prevention and control as in Article 9 of the AHL, the AHAW Panel concluded that SVC does not meet the criteria in Section 1 (Category A; 5-33% probability of meeting the criteria) and it is uncertain whether it meets the criteria in Sections 2, 3, 4 and 5 (Categories B, C, D and E; 33-66%, 10-66%, 45-90% and 45-90% probability of meeting the criteria, respectively). The animal species to be listed for SVC according to Article 8 criteria are provided., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Infection with salmonid alphavirus (SAV) was assessed according to the criteria of the Animal Health Law (AHL), in particular the criteria of Article 7 on disease profile and impacts, Article 5 on its eligibility to be listed, Annex IV for its categorisation according to disease prevention and control rules as laid out in Article 9 and Article 8 for listing animal species related to infection with SAV. The assessment was performed following the ad hoc method on data collection and assessment developed by AHAW Panel and already published. The outcome reported is the median of the probability ranges provided by the experts, which indicates whether each criterion is fulfilled (lower bound ≥ 66%) or not (upper bound ≤ 33%), or whether there is uncertainty about fulfilment. Reasoning points are reported for criteria with an uncertain outcome. According to the assessment, it was uncertain whether infection with salmonid alphavirus can be considered eligible to be listed for Union intervention according to Article 5 of the AHL (50-80% probability). According to the criteria in Annex IV, for the purpose of categorisation related to the level of prevention and control as in Article 9 of the AHL, the AHAW Panel concluded that infection with salmonid alphavirus does not meet the criteria in Section 1 (Category A; 5-10% probability of meeting the criteria) and it is uncertain whether it meets the criteria in Sections 2, 3, 4 and 5 (Categories B, C, D and E; 50-90%, probability of meeting the criteria). The animal species to be listed for infection with SAV according to Article 8 criteria are provided., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Infection with Gyrodactylus salaris was assessed according to the criteria of the Animal Health Law (AHL), in particular, the criteria of Article 7 on disease profile and impacts, Article 5 on its eligibility to be listed, Annex IV for its categorisation according to disease prevention and control rules as laid down in Article 9 and Article 8 for listing animal species related to infection with G. salaris . The assessment was performed following the ad hoc method for data collection and assessment previously developed by AHAW panel and already published. The outcome reported is the median of the probability ranges provided by the experts, which indicates whether each criterion is fulfilled (lower bound ≥ 66%) or not (upper bound ≤ 33%), or whether there is uncertainty about fulfilment. Reasoning points are reported for criteria with an uncertain outcome. According to the assessment here performed, it is uncertain whether infection with G. salaris can be considered eligible to be listed for Union intervention according to Article 5 of the AHL (33-70% probability). According to the criteria in Annex IV, for the purpose of categorisation related to the level of prevention and control as in Article 9 of the AHL, the AHAW Panel concluded that Infection with G. salaris does not meet the criteria in Section 1 and 3 (Category A and C; 1-5% and 10-33% probability of fulfilling the criteria, respectively) and it is uncertain whether it meets the criteria in Sections 2, 4 and 5 (Categories B, D and E; 33-80%, 33-66% and 33-80% probability of meeting the criteria, respectively). The animal species to be listed for infection with G. salaris according to Article 8 criteria are provided., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Bacterial kidney disease (BKD) was assessed according to the criteria of the Animal Health Law (AHL), in particular the criteria of Article 7 on disease profile and impacts, Article 5 on its eligibility to be listed, Annex IV for its categorisation according to disease prevention and control rules as laid out in Article 9 and Article 8 for listing animal species related to BKD. The assessment was performed following the ad hoc method on data collection and assessment developed by AHAW Panel and already published. The outcome reported is the median of the probability ranges provided by the experts, which indicates whether each criterion is fulfilled (lower bound ≥ 66%) or not (upper bound ≤ 33%), or whether there is uncertainty about fulfilment. Reasoning points are reported for criteria with an uncertain outcome. According to this assessment, BKD can be considered eligible to be listed for Union intervention according to Article 5 of the AHL (66-90% probability). According to the criteria in Annex IV, for the purpose of categorisation related to the level of prevention and control as in Article 9 of the AHL, the AHAW Panel concluded that BKD does not meet the criteria in Sections 1, 2 and 3 (Categories A, B and C; 1-5%, 33-66% and 33-66% probability of meeting the criteria, respectively) but meets the criteria in Sections 4 and 5 (Categories D and E; 66-90% and 66-90% probability of meeting the criteria, respectively). The animal species to be listed for BKD according to Article 8 criteria are provided., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Vector or reservoir species of three diseases of crustaceans listed in the Animal Health Law were identified based on evidence generated through an extensive literature review, to support a possible updating of Regulation (EU) 2018/1882. Crustacean species on or in which Taura syndrome virus (TSV), Yellow head virus (YHV) or White spot syndrome virus (WSSV) were identified, in the field or during experiments, were classified as reservoir species with different levels of certainty depending on the diagnostic tests used. Where experimental evidence indicated transmission of the pathogen from a studied species to another known susceptible species, the studied species was classified as vector species. Although the quantification of the risk of spread of the pathogens by the vectors or reservoir species was not part of the terms of reference, such risks do exist for the vector species, since transmission from infected vector species to susceptible species was proven. Where evidence for transmission from infected crustaceans was not found, these were defined as reservoirs. Nonetheless, the risk of the spread of the pathogens from infected reservoir species cannot be excluded. Evidence identifying conditions that may prevent transmission by vectors during transport was collected from scientific literature. It was concluded that it is very likely to almost certain (90-100%) that WSSV, TSV and YHV will remain infective at any possible transport condition. Therefore, vector or reservoir species that may have been exposed to these pathogens in an affected area in the wild or aquaculture establishments or by water supply can possibly transmit WSSV, TSV and YHV., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Vector or reservoir species of five mollusc diseases listed in the Animal Health Law were identified, based on evidence generated through an extensive literature review, to support a possible updating of Regulation (EU) 2018/1882. Mollusc species on or in which Mikrocytos mackini , Perkinsus marinus , Bonamia exitiosa , Bonamia ostreae and Marteilia refringens were detected, in the field or during experiments, were classified as reservoir species with different levels of certainty depending on the diagnostic tests used. Where experimental evidence indicated transmission of the pathogen from a studied species to another known susceptible species, this studied species was classified as a vector species. Although the quantification of the risk of spread of the pathogens by the vectors or reservoir species was not part of the terms of reference, such risks do exist for the vector species, since transmission from infected vector species to susceptible species was proven. Where evidence for transmission from infected molluscs was not found, these were defined as reservoir. Nonetheless, the risk of the spread of the pathogens from infected reservoir species cannot be excluded. Evidence identifying conditions that may prevent transmission by vectors or reservoir mollusc species during transport was collected from scientific literature. It was concluded that it is very likely to almost certain (90-100%) that M. mackini, P. marinus, B. exitiosa B. ostreae and M. refringens will remain infective at any possible transport condition. Therefore, vector or reservoir species that may have been exposed to these pathogens in an affected area in the wild or at aquaculture establishments or through contaminated water supply can possibly transmit these pathogens. For transmission of M. refringens, the presence of an intermediate host, a copepod, is necessary., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Vector or reservoir species of five fish diseases listed in the Animal Health Law were identified, based on evidence generated through an extensive literature review (ELR), to support a possible updating of Regulation (EU) 2018/1882. Fish species on or in which highly polymorphic region-deleted infectious salmon anaemia virus (HPR∆ ISAV), Koi herpes virus (KHV), epizootic haematopoietic necrosis virus (EHNV), infectious haematopoietic necrosis virus (IHNV) or viral haemorrhagic septicaemia virus (VHSV) were detected, in the field or during experiments, were classified as reservoir species with different levels of certainty depending on the diagnostic tests used. Where experimental evidence indicated transmission of the pathogen from a studied species to another known susceptible species, the studied species was classified as a vector species. Although the quantification of the risk of spread of the pathogens by the vectors or reservoir species was not part of the terms or reference, such risks do exist for the vector species, since transmission from infected vector species to susceptible species was proven. Where evidence for transmission from infected fish was not found, these were defined as reservoirs. Nonetheless, the risk of the spread of the pathogens from infected reservoir species cannot be excluded. Evidence identifying conditions that may prevent transmission by vectors or reservoir fish species during transport was collected from scientific literature. For VHSV, IHNV or HPR∆ ISAV, it was concluded that under transport conditions at temperatures below 25°C, it is likely (66-90%) they will remain infective. Therefore, vector or reservoir species that may have been exposed to these pathogens in an affected area in the wild, aquaculture establishments or through water supply can possibly transmit VHSV, IHNV or HPR∆ ISAV into a non-affected area when transported at a temperature below 25°C. The conclusion was the same for EHN and KHV; however, they are likely to remain infective under all transport temperatures., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Infectious pancreatic necrosis (IPN) was assessed according to the criteria of the Animal Health Law (AHL), in particular, the criteria of Article 7 on disease profile and impacts, Article 5 on its eligibility to be listed, Annex IV for its categorisation according to disease prevention and control rules as in Article 9, and Article 8 for listing animal species related to IPN. The assessment was performed following a methodology previously published. The outcome reported is the median of the probability ranges provided by the experts, which indicates whether each criterion is fulfilled (lower bound ≥ 66%) or not (upper bound ≤ 33%), or whether there is uncertainty about fulfilment. Reasoning points are reported for criteria with an uncertain outcome. According to the assessment here performed, it is uncertain whether IPN can be considered eligible to be listed for Union intervention according to Article 5 of the AHL (50-90% probability). According to the criteria in Annex IV, for the purpose of categorisation related to the level of prevention and control as in Article 9 of the AHL, the AHAW Panel concluded that IPN does not meet the criteria in Section 1 (Category A; 0-1% probability of meeting the criteria) and it is uncertain whether it meets the criteria in Sections 2, 3, 4 and 5 (Categories B, C, D and E; 33-66%, 33-66%, 50-90% and 50-99% probability of meeting the criteria, respectively). The animal species to be listed for IPN according to Article 8 criteria are provided., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for Contagious Caprine Pleuropneumonia (CCPP). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period, (iii) the minimum radius of the protection and surveillance zones and iv) the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. Different clinical and laboratory sampling procedures are proposed depending on the scenarios considered. The monitoring period of 45 days was assessed as effective in affected areas where high awareness is expected, and when the index case occurs in an area where the awareness is low the monitoring period should be at least 180 days (6 months). Since transmission kernels do not exist and data to estimate transmission kernels are not available, a surveillance zone of 3 km was considered effective based on expert knowledge, while a protection zone should also be developed to include establishments adjacent to affected ones. Recommendations, provided for each of the scenarios assessed, aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to CCPP., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

EFSA received a mandate from the EC to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures are assessed, with this opinion covering the assessment of control measures for Lumpy Skin Disease (LSD). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: i) clinical and laboratory sampling procedures, ii) monitoring period and iii) the minimum radius of the protection and surveillance zones, and the minimum length of time that measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, the transmission kernels used for the assessment of the minimum radius of the protection and surveillance zones are shown. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. The monitoring period was assessed as effective, and based on the transmission kernels available, it was concluded that the protection zone of 20 km radius and the surveillance zone of 50 km radius would comprise > 99% of the transmission from an affected establishment if transmission occurred. Recommendations provided for each of the assessed scenarios aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to LSD., (© 2022 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for Contagious Bovine Pleuropneumonia (CBPP). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period, (iii) the minimum radius of the protection and surveillance zones, and (iv) the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. Different clinical and laboratory sampling procedures are proposed depending on the scenarios considered. The monitoring period of 45 days was assessed as not effective and at least 90 days (3 months) is recommended in affected areas where high awareness is expected; when the index case occurs in an area where the awareness is low the monitoring period should be at least 180 days (6 months). Since transmission kernels do not exist and data to estimate transmission kernels are not available, the effectiveness of surveillance and protection zones for CBPP was based on expert knowledge. A surveillance zone of 3 km was considered effective, while a protection zone including establishments adjacent to affected ones is recommended. Recommendations, provided for each of the scenarios assessed, aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to CBPP., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for glanders. In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radius of the protection and surveillance zone, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere. Considering the epidemiology and distribution of glanders, it was foreseen that three different situations could lead to a suspicion of the disease. Sampling procedures were defined for each of the three different suspicion types, which can also be applied in most of the other scenarios assessed. The monitoring period (6 months) was assessed as effective in all scenarios. The AHAW Panel of experts considered the minimum radius and duration of the existing protection and surveillance zone, set at the establishment level, effective. Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to glanders., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for Newcastle disease (ND). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radius of the protection and surveillance zone, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. The monitoring period (21 days) was assessed as effective in non-vaccinated chicken and turkey flocks, although large uncertainty remains surrounding the effectiveness of this period in vaccinated galliform flocks and flocks of other bird species. It was also concluded that the protection (3 km radius) and the surveillance (10 km radius) zones contain 99% of the infections from an infectious establishment. Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to ND., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for Classical swine fever (CSF). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radii of the protection and surveillance zones, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, details of the model used for answering these questions are presented in this opinion as well as the transmission kernels used for the assessment of the minimum radius of the protection and surveillance zones. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. Here, several recommendations are given on how to increase the effectiveness of some of the sampling procedures. Based on the average length of the period between virus introduction and the reporting of a CSF suspicion, the monitoring period was assessed as non-effective. In a similar way, it was recommended that the length of the measures in the protection and surveillance zones were increased from 15 to 25 days in the protection zone and from 30 to 40 days in the surveillance zone. Finally, the analysis of existing Kernels for CSF suggested that the radius of the protection and the surveillance zones comprise 99% of the infections from an affected establishment if transmission occurred. Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to CSF., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

This opinion describes outdoor farming of pigs in the EU, assesses the risk of African swine fewer (ASF) introduction and spread associated with outdoor pig farms and proposes biosecurity and control measures for outdoor pig farms in ASF-affected areas of the EU. Evidence was collected from Member States (MSs) veterinary authorities, farmers' associations, literature and legislative documents. An Expert knowledge elicitation (EKE) was carried out to group outdoor pig farms according to their risk of introduction and spread of ASF, to rank biosecurity measures regarding their effectiveness with regard to ASF and propose improvements of biosecurity for outdoor pig farming and accompanying control measures. Outdoor pig farming is common and various farm types are present throughout the EU. As there is no legislation at European level for categorising outdoor pig farms in the EU, information is limited, not harmonised and needs to be interpreted with care. The baseline risk of outdoor pig farms for ASFV introduction and its spread is high but with considerable uncertainty. The Panel is 66-90% certain that, if single solid or double fences were fully and properly implemented on all outdoor pig farms in areas of the EU where ASF is present in wild boar and in domestic pigs in indoor farms and outdoor farms (worst case scenario not considering different restriction zones or particular situations), without requiring any other outdoor-specific biosecurity measures or control measures, this would reduce the number of new ASF outbreaks occurring in these farms within a year by more than 50% compared to the baseline risk. The Panel concludes that the regular implementation of independent and objective on-farm biosecurity assessments using comprehensive standard protocols and approving outdoor pig farms on the basis of their biosecurity risk in an official system managed by competent authorities will further reduce the risk of ASF introduction and spread related to outdoor pig farms., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for foot and mouth disease (FMD). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: i) clinical and laboratory sampling procedures, ii) monitoring period and iii) the minimum radius of the protection and surveillance zones, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, the transmission kernels used for the assessment of the minimum radius of the protection zone of 3 km and of the surveillance zone of 10 km are shown. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. The monitoring period of 21 days was assessed as effective, and it was concluded that the protection and the surveillance zones comprise > 99% of the infections from an affected establishment if transmission occurred. Recommendations, provided for each of the scenarios assessed, aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to FMD., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for African Horse Sickness (AHS). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radius of the protection and surveillance zone, and the minimum duration of measures in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, specific details of the transmission kernels used for the assessment of the minimum radius of the protection and surveillance zones are shown. Several scenarios for which these control measures were assessed were designed and agreed prior to the start of the assessment. In summary, sampling procedures described in the diagnostic manual for AHS were considered efficient for all Equidae considering the high case fatality rate expected. The monitoring period (14 days) was assessed as effective in every scenario, except for those relating to the epidemiological enquiry where the risk manager should consider increasing the monitoring period, based on the awareness of keepers, environmental conditions and the vector abundance in the region. The current protection zone (100 km) comprises more than 95% of the infections from an affected establishment. Both the radius and duration of the zones could be reduced, based on local environmental conditions and the time of year of the first index case. Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation relating to AHS., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for African Swine Fever (ASF). In this opinion, EFSA and the AHAW Panel of experts reviewed the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radius of the protection and surveillance zone, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, specific details of the model used for the assessment of the laboratory sampling procedures for ASF are presented here. Here, also, the transmission kernels used for the assessment of the minimum radius of the protection and surveillance zones are shown. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. In summary, several sampling procedures as described in the diagnostic manual for ASF were considered ineffective and a suggestion to exclude, or to substitute with more effective procedures was made. The monitoring period was assessed as non-effective for several scenarios and a longer monitoring period was suggested to ensure detection of potentially infected herds. It was demonstrated that the surveillance zone comprises 95% of the infections from an affected establishment, and therefore is considered effective. Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to ASF., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for Highly Pathogenic Avian Influenza (HPAI). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radius of the protection and surveillance zone, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, specific details of the model used for the assessment of the laboratory sampling procedures for HPAI are presented here. Here, also, the transmission kernels used for the assessment of the minimum radius of the protection and surveillance zones are shown. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. In summary, sampling procedures as described in the diagnostic manual for HPAI were considered efficient for gallinaceous poultry, whereas additional sampling is advised for Anseriformes. The monitoring period was assessed as effective, and it was demonstrated that the surveillance zone comprises 95% of the infections from an affected establishment. Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to HPAI., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Effectiveness of surveillance and control measures against Rift Valley Fever (RVF) in Mayotte (overseas France) and in continental EU were assessed using mathematical models. Surveillance for early detection of RVF virus circulation implies very low design prevalence values and thus sampling a high number of animals, so feasibility issues may rise. Passive surveillance based on notified abortions in ruminants is key for early warning and at present the only feasible surveillance option. The assessment of vaccination and culling against RVF in Mayotte suggests that vaccination is more effective when quickly implemented throughout the population, e.g. at a rate of 200 or 2,000 animals vaccinated per day. Test and cull is not an option for RVF control in Mayotte given the high number of animals that would need to be tested. If the risk of RVFV introduction into the continental EU increases, ruminant establishments close to possible points of disease incursion should be included in the surveillance. An enhanced surveillance on reproductive disorders should be applied during summer in risk areas. Serosurveillance targets of 0.3% animals should be at least considered. RVF control measures possibly applied in the continental EU have been assessed in the Netherlands, as an example. Culling animals on farms within a 20 km radius of detected farms appears as the most effective measure to control RVF spread, although too many animals should be culled. Alternative measures are vaccination in a 50 km radius around detection, ring vaccination between 20 and 50 km and culling of detected farms. The assessment of zoning showed that, following RVFV introduction and considering an R 0 = 2, a mean vector dispersal of 10 km and 10 farms initially detected, RVFV would spread beyond a radius of up to 100 km or 50 km from the infected area with 10% or 55% probability, respectively., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Rift Valley fever (RVF) is a vector-borne disease transmitted by different mosquito species, especially Aedes and Culex genus, to animals and humans. In November 2018, RVF re-emerged in Mayotte (France) after 11 years. Up to the end of October 2019, 126 outbreaks in animals and 143 human cases were reported. RVF mortality was 0.01%, and the number of abortions reported in polymerase chain reaction (PCR)-positive ruminants was fivefold greater than the previous 7 years. Milk loss production in 2019 compared to 2015-2018 was estimated to be 18%, corresponding to an economic loss of around €191,000 in all of Mayotte. The tropical climate in Mayotte provides conditions for the presence of mosquitoes during the whole year, and illegal introductions of animals represent a continuous risk of (re)introduction of RVF. The probability of RVF virus (RVFV) persisting in Mayotte for 5 or more years was estimated to be < 10% but could be much lower if vertical transmission in vectors does not occur. Persistence of RVF by vertical transmission in Mayotte and Réunion appears to be of minor relevance compared to other pathways of re-introduction (i.e. animal movement). However, there is a high uncertainty since there is limited information about the vertical transmission of some of the major species of vectors of RVFV in Mayotte and Réunion. The only identified pathways for the risk of spread of RVF from Mayotte to other countries were by infected vectors transported in airplanes or by wind currents. For the former, the risk of introduction of RVF to continental France was estimated to 4 × 10 -6 epidemic per year (median value; 95% CI: 2 × 10 -8 ; 0.0007), and 0.001 epidemic per year to Réunion (95% CI: 4 × 10 -6 ; 0.16). For the latter pathway, mosquitoes dispersing on the wind from Mayotte between January and April 2019 could have reached the Comoros Islands, Madagascar, Mozambique and, possibly, Tanzania. However, these countries are already endemic for RVF, and an incursion of RVFV-infected mosquitoes would have negligible impact., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

In 2019, no lumpy skin disease (LSD) outbreaks were reported in South-Eastern Europe, the mass vaccination regional campaign with homologous LSD vaccine continued for the fourth year with over 1.8 million bovines vaccinated in the region, preventing further outbreaks since 2016. LSD outbreaks were reported in Turkey, including western Turkey, in Russia and in eastern Asia affecting China, Bangladesh and India for the first time. The use of homologous vaccine should be considered in the countries still affected in order to eliminate the virus. Besides passive surveillance, which is implemented in all the countries, active surveillance for early detection based on clinical examination could be conducted ideally during April-October every 5 weeks in at-risk areas, based on possible re-emergence or re-introduction from affected neighbouring countries. Active surveillance for proving disease freedom could be based on serological testing (enzyme-linked immunosorbent assay (ELISA)) targeting 3.5% seroprevalence and conducted on a random sample of cattle herds on non-vaccinated animals. LSD re-emerged in Israel in 2019, after vaccination became voluntary. This shows that, if the virus is still circulating in the region, the reduced protection might result in re-emergence of LSD. In case of re-emergence, a contingency plan and vaccine stockpiling would be needed, in order to react quickly. From a study performed in Israel to test side effects of live-attenuated homologous LSD vaccine, milk production can be reduced during 7 days after vaccination (around 6-8 kg per cow), without a significant loss in the 30 days after vaccination. Research needs should be focused on the probability of transmission from insect to bovine, the virus inactivation rate in insects, the collection of baseline entomological data, the capacity of vector species in LSDV transmission linked to studies on their abundance and the control of Stomoxys calcitrans being the most important vector in LSD transmission., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The European Commission requested EFSA to estimate the risk of spread of African swine fever (ASF) and to identify potential risk factors (indicators) for the spread of ASF, given introduction in the south-eastern countries of Europe (region of concern, ROC), namely Albania, Bosnia and Herzegovina, Croatia, Greece, Kosovo, Montenegro, North Macedonia, Serbia and Slovenia. Three EU Member States (MS) - Croatia, Greece and Slovenia - were included in the ROC due to their geographical location and ASF-free status. Based on collected information on potential risk factors (indicators) for each country and the relevant EU regulations in force, the estimated probability of spread of ASF within the ROC within one year after introduction into the ROC was assessed to be very high (from 66% to 100%). This estimate was determined after considering the high number of indicators present in most of the countries in the ROC and the known effect that these indicators can have on ASF spread, especially those related to the structure of the domestic pig sector, the presence of wild boar and social factors. The presence of indicators varies between countries in the ROC. Each country is at risk of ASF spread following introduction; however, some countries may have a higher probability of ASF spread following introduction. In addition, the probability of ASF spread from the ROC to EU MSs outside the ROC within one year after introduction of ASF in the ROC was estimated to be very low to low (from 0% to 15%). This estimate was based on the comparison of the indicators present in the ROC and the already affected countries in south-eastern Europe, such as Bulgaria and Romania, where there was no evidence of ASF spread to other EU MS within one year., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

In 2018, no lumpy skin disease (LSD) outbreaks were reported in the Balkan region, after the decline reported in 2017 (385) compared to 2016 (7,483). This confirms the effectiveness of the vaccination campaign based on the LSD homologous vaccine strain which continued throughout 2018 with over 2.5 million animals vaccinated, keeping the mean vaccination coverage above 70%. In 2018, LSD outbreaks were reported in Russia, Turkey and Georgia. In Russia, the LSD epidemics expanded northward and eastward, while in Turkey, the most affected region was in the east. LSD is spreading in Turkey since 2013, despite large vaccination campaigns with heterologous vaccine performed since 2014. This might support the hypothesis that the use of heterologous vaccines results in insufficient protection, and therefore, the use of homologous LSD vaccine in Turkey should be considered to prevent further spread. As the LSD epidemic in Turkey is a risk for reintroduction into the EU, it is recommended to continue the vaccination campaigns in 2019 in the high-risk areas of Balkan region. Spread rates of LSD within a village were estimated from outbreak data for Albania, which can be used to inform the level of vaccination required to control an outbreak in a village. In terms of vaccine safety, the reports from the field suggest that, compared to the large number of animals vaccinated in the Balkan region since 2015, a very limited number of side effects have been recorded so far, although from published literature, local or even systemic side effects in some animals may occur after vaccination. However, due to inadequate study design in the reviewed studies, there is no consensus on the magnitude of such effects and on their real consequences on production., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The European Commission is routinely asking EFSA for scientific and technical support in the epidemiological analysis of animal disease outbreaks (i.e. African swine fever, lumpy skin disease and avian influenza) and to report or assess surveillance data (i.e. Echinococcus multilocularis and avian influenza). For this purpose, EFSA has over the last years carried out several data collections and gathered specific information on outbreaks, surveillance activities and concerned animal populations (i.e. poultry, domestic pigs, cattle and wildlife such as wild boar). EFSA aims to work together closely with Member States in order to (i) reduce the Member States' manual input of the data to be submitted to EFSA; (ii) avoid double reporting to EFSA; (iii) provide the Member States with tools to produce automatically their own draft national reports on animal health and surveillance in a protected environment to ensure data protection; (iv) increase the quality of the data received from the Member States; and (v) shorten the time to retrieve up-to-date data, relevant for risk assessment purposes. With this purpose, EFSA launched a project called SIGMA. It is important to highlight that the SIGMA - Animal Disease Data Model (σ-ADM) focuses on data which are known to be already collected by several Member States under different legal frameworks and for different purposes. The version presented in this report, will be subject to modifications and updates derived from the feedback during the implementation phase., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)