Liisa Sihvonen

Ad hoc method for the assessment on listing and categorisation of animal diseases within the framework of the Animal Health Law

Abstract The European Commission has requested EFSA to assess animal diseases according to the criteria as laid down in Articles 5, 7, 8 and Annex IV for the purpose of categorisation of diseases in accordance with Article 9 of the Regulation (EU) No 2016/429 (Animal Health Law). This scientific opinion addresses the ad hoc method developed for assessing any animal disease for the listing and categorisation of diseases within the Animal Health Law (AHL) framework. The assessment of individual diseases is addressed in distinct scientific opinions that are published separately. The assessment of Articles 5, 8 and 9 criteria is performed on the basis of the information collected according to Article 7 criteria. For that purpose, Article 7 criteria were structured into parameters and the information was collected at parameter level. The resulting fact sheets on the profile and impact of each disease were compiled by disease scientists. A mapping was developed to identify which parameters from Article 7 were needed to inform each Article 5, 8 and 9 criterion. Specifically, for Articles 5 and 9 criteria, a categorical assessment was performed, by applying an expert judgement procedure, based on the mapped information. The judgement was performed by EFSA Panel experts on Animal Health and Welfare in two rounds, individual and collective judgement. The output of the expert judgement on the criteria of Articles 5 and 9 for each disease is composed by the categorical answer, and for the questions where no consensus was reached, the different supporting views are reported.

Urgent request on avian influenza

Abstract Highly pathogenic avian influenza (HPAI) H5N8 is currently causing an epizootic in Europe, infecting many poultry holdings as well as captive and wild bird species in more than 10 countries. Given the clear clinical manifestation, passive surveillance is considered the most effective means of detecting infected wild and domestic birds. Testing samples from new species and non‐previously reported areas is key to determine the geographic spread of HPAIV H5N8 2016 in wild birds. Testing limited numbers of dead wild birds in previously reported areas is useful when it is relevant to know whether the virus is still present in the area or not, e.g. before restrictive measures in poultry are to be lifted. To prevent introduction of HPAIV from wild birds into poultry, strict biosecurity implemented and maintained by the poultry farmers is the most important measure. Providing holding‐specific biosecurity guidance is strongly recommended as it is expected to have a high impact on the achieved biosecurity level of the holding. This is preferably done during peace time to increase preparedness for future outbreaks. The location and size of control and in particular monitoring areas for poultry associated with positive wild bird findings are best based on knowledge of the wider habitat and flight distance of the affected wild bird species. It is recommended to increase awareness among poultry farmers in these established areas in order to enhance passive surveillance and to implement enhanced biosecurity measures including poultry confinement. There is no scientific evidence suggesting a different effectiveness of the protection measures on the introduction into poultry holdings and subsequent spread of HPAIV when applied to H5N8, H5N1 or other notifiable HPAI viruses.

Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429): paratuberculosis

Abstract Paratuberculosis has been assessed according to the criteria of the Animal Health Law (AHL), in particular criteria of Article 7 on disease profile and impacts, Article 5 on the eligibility of paratuberculosis to be listed, Article 9 for the categorisation of paratuberculosis according to disease prevention and control rules as in Annex IV and Article 8 on the list of animal species related to paratuberculosis. The assessment has been performed following a methodology composed of information collection and compilation, expert judgement on each criterion at individual and, if no consensus was reached before, also at collective level. The output is composed of the categorical answer, and for the questions where no consensus was reached, the different supporting views are reported. Details on the methodology used for this assessment are explained in a separate opinion. According to the assessment performed, paratuberculosis can be considered eligible to be listed for Union intervention as laid down in Article 5(3) of the AHL. The disease would comply with the criteria in Sections 3, 4 and 5 of Annex IV of the AHL, for the application of the disease prevention and control rules referred to in points (c), (d) and (e) of Article 9(1). The animal species to be listed for paratuberculosis according to Article 8(3) criteria are several species of mammals and birds as susceptible species and some species of the families Bovidae, Cervidae and Leporidae as reservoirs.

African swine fever in wild boar

Abstract The European Commission requested EFSA to compare the reliability of wild boar density estimates across the EU and to provide guidance to improve data collection methods. Currently, the only EU‐wide available data are hunting data. Their collection methods should be harmonised to be comparable and to improve predictive models for wild boar density. These models could be validated by more precise density data, collected at local level e.g. by camera trapping. Based on practical and theoretical considerations, it is currently not possible to establish wild boar density thresholds that do not allow sustaining African swine fever (ASF). There are many drivers determining if ASF can be sustained or not, including heterogeneous population structures and human‐mediated spread and there are still unknowns on the importance of different transmission modes in the epidemiology. Based on extensive literature reviews and observations from affected Member States, the efficacy of different wild boar population reduction and separation methods is evaluated. Different wild boar management strategies at different stages of the epidemic are suggested. Preventive measures to reduce and stabilise wild boar density, before ASF introduction, will be beneficial both in reducing the probability of exposure of the population to ASF and the efforts needed for potential emergency actions (i.e. less carcass removal) if an ASF incursion were to occur. Passive surveillance is the most effective and efficient method of surveillance for early detection of ASF in free areas. Following focal ASF introduction, the wild boar populations should be kept undisturbed for a short period (e.g. hunting ban on all species, leave crops unharvested to provide food and shelter within the affected area) and drastic reduction of the wild boar population may be performed only ahead of the ASF advance front, in the free populations. Following the decline in the epidemic, as demonstrated through passive surveillance, active population management should be reconsidered.

Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429): infection with Brucella abortus, B. melitensis and B. suis

Abstract The infection with Brucella abortus, Brucella melitensis and Brucella suis has been assessed according to the criteria of the Animal Health Law (AHL), in particular criteria of Article 7 on disease profile and impacts, Article 5 on the eligibility of the infection with B. abortus, B. melitensis and B. suis to be listed, Article 9 for the categorisation of the infection with B. abortus, B. melitensis and B. suis according to disease prevention and control rules as in Annex IV and Article 8 on the list of animal species related to the infection with B. abortus, B. melitensis and B. suis. The assessment has been performed following a methodology composed of information collection and compilation, expert judgement on each criterion at individual and, if no consensus was reached before, also at collective level. The output is composed of the categorical answer, and for the questions where no consensus was reached, the different supporting views are reported. Details on the methodology used for this assessment are explained in a separate opinion. According to the assessment performed, the infection with B. abortus, B. melitensis and B. suis can be considered eligible to be listed for Union intervention as laid down in Article 5(3) of the AHL. The disease complies with the criteria as in Sections 2, 3, 4 and 5 of Annex IV of the AHL, for the application of the disease prevention and control rules referred to in points (b), (c), (d) and (e) of Article 9(1). The animal species to be listed for the infection with B. abortus, B. melitensis and B. suis according to Article 8(3) criteria are several mammal species, as indicated in the present opinion.

Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429): Salmonella infection in poultry with serotypes of animal health relevance (S. Pullorum, S. Gallinarum and S. arizonae)

Abstract Salmonella infection in poultry (Salmonella Pullorum, Salmonella Gallinarum and Salmonella arizonae) has been assessed according to the criteria of the Animal Health Law (AHL), in particular criteria of Article 7 on disease profile and impacts, Article 5 on the eligibility of Salmonella to be listed, Article 9 for the categorisation of Salmonella according to disease prevention and control rules as in Annex IV and Article 8 on the list of animal species related to Salmonella. The assessment has been performed following a methodology composed of information collection and compilation, expert judgement on each criterion at individual and, if no consensus was reached before, also at collective level. The output is composed of the categorical answer, and for the questions where no consensus was reached, the different supporting views are reported. Details on the methodology used for this assessment are explained in a separate opinion. According to the assessment performed, Salmonella can be considered eligible to be listed for Union intervention as laid down in Article 5(3) of the AHL. The disease would comply with the criteria as in Sections 4 and 5 of Annex IV of the AHL, for the application of the disease prevention and control rules referred to in points (d) and (e) of Article 9(1). The assessment here performed on compliance with the criteria as in Section 1 of Annex IV referred to in point (a) of Article 9(1) is inconclusive. The main animal species to be listed for Salmonella according to Article 8(3) criteria are all species of domestic poultry and wild species of mainly Anseriformes and Galliformes, as indicated in the present opinion.

Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429): enzootic bovine leukosis (EBL)

Abstract Enzootic bovine leucosis (EBL) has been assessed according to the criteria of the Animal Health Law (AHL), in particular criteria of Article 7 on disease profile and impacts, Article 5 on the eligibility of EBL to be listed, Article 9 for the categorisation of EBL according to disease prevention and control rules as in Annex IV and Article 8 on the list of animal species related to EBL. The assessment has been performed following a methodology composed of information collection and compilation, expert judgement on each criterion at individual and, if no consensus was reached before, also at collective level. The output is composed of the categorical answer, and for the questions where no consensus was reached, the different supporting views are reported. Details on the methodology used for this assessment are explained in a separate opinion. According to the assessment performed, it is inconclusive whether EBL can be considered eligible to be listed for Union intervention as laid down in Article 5(3) of the AHL because there was no full consensus on the criteria 5 B(i) and 5 B(iii). Consequently, since it is inconclusive whether EBL can be considered eligible to be listed for Union intervention as laid down in Article 5(3) of the AHL, then the assessment on compliance of EBL with the criteria as in Sections 4 and 5 of Annex IV to the AHL, for the application of the disease prevention and control rules referred to in points (d) and (e) of Article 9(1), and which animal species can be considered to be listed for EBL according to Article 8(3) of the AHL is also inconclusive.

Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429): bovine tuberculosis

Abstract Bovine tuberculosis has been assessed according to the criteria of the Animal Health Law (AHL), in particular criteria of Article 7 on disease profile and impacts, Article 5 on the eligibility of bovine tuberculosis to be listed, Article 9 for the categorisation of bovine tuberculosis according to disease prevention and control rules as in Annex IV and Article 8 on the list of animal species related to bovine tuberculosis. The assessment has been performed following a methodology composed of information collection and compilation, expert judgement on each criterion at individual and, if no consensus was reached before, also at collective level. The output is composed of the categorical answer, and for the questions where no consensus was reached, the different supporting views are reported. Details on the methodology used for this assessment are explained in a separate opinion. According to the assessment performed, bovine tuberculosis can be considered eligible to be listed for Union intervention as laid down in Article 5(3) of the AHL. The disease would comply with the criteria as in Sections 2, 3, 4 and 5 of Annex IV of the AHL, for the application of the disease prevention and control rules referred to in points (b), (c), (d) and (e) of Article 9(1). The main animal species to be listed for bovine tuberculosis according to Article 8(3) criteria are several mammal species, as indicated in the present opinion.

Guidance on the assessment criteria for applications for new or modified stunning methods regarding animal protection at the time of killing

Abstract This guidance defines the process for handling applications on new or modified stunning methods and the parameters that will be assessed by the EFSA Animal Health and Welfare (AHAW) Panel. The applications, received through the European Commission, should contain administrative information, a checklist of data to be submitted and a technical dossier. The dossier should include two or more studies (in laboratory and slaughterhouse conditions) reporting all parameters and methodological aspects that are indicated in the guidance. The applications will first be scrutinised by the EFSAs Applications Desk (APDESK) Unit for verification of the completeness of the data submitted for the risk assessment of the stunning method. If the application is considered not valid, additional information may be requested from the applicant. If considered valid, it will be subjected to assessment phase 1 where the data related to parameters for the scientific evaluation of the stunning method will be examined by the AHAW Panel. Such parameters focus on the stunning method and the outcomes of interest, i.e. immediate onset of unconsciousness or the absence of avoidable pain, distress and suffering until the loss of consciousness and duration of the unconsciousness (until death). The applicant should also propose methodologies and results to assess the equivalence with existing stunning methods in terms of welfare outcomes. Applications passing assessment phase 1 will be subjected to the following phase 2 which will be carried out by the AHAW Panel and focuses on the animal welfare risk assessment. In this phase, the Panel will assess the outcomes, conclusions and discussion proposed by the applicant. The results of the assessment will be published in a scientific opinion.

Risk of survival, establishment and spread of Batrachochytrium salamandrivorans (Bsal) in the EU

Abstract Batrachochytrium salamandrivorans (Bsal) is an emerging fungal pathogen of salamanders. Despite limited surveillance, Bsal was detected in kept salamanders populations in Belgium, Germany, Spain, the Netherlands and the United Kingdom, and in wild populations in some regions of Belgium, Germany and the Netherlands. According to niche modelling, at least part of the distribution range of every salamander species in Europe overlaps with the climate conditions predicted to be suitable for Bsal. Passive surveillance is considered the most suitable approach for detection of Bsal emergence in wild populations. Demonstration of Bsal absence is considered feasible only in closed populations of kept susceptible species. In the wild, Bsal can spread by both active (e.g. salamanders, anurans) and passive (e.g. birds, water) carriers; it is most likely maintained/spread in infected areas by contacts of salamanders or by interactions with anurans, whereas human activities most likely cause Bsal entry into new areas and populations. In kept amphibians, Bsal contamination via live silent carriers (wild birds and anurans) is considered extremely unlikely. The risk‐mitigation measures that were considered the most feasible and effective: (i) for ensuring safer international or intra‐EU trade of live salamanders, are: ban or restrictions on salamander imports, hygiene procedures and good practice manuals; (ii) for protecting kept salamanders from Bsal, are: identification and treatment of positive collections; (iii) for on‐site protection of wild salamanders, are: preventing translocation of wild amphibians and release/return to the wild of kept/temporarily housed wild salamanders, and setting up contact points/emergency teams for passive surveillance. Combining several risk‐mitigation measures improve the overall effectiveness. It is recommended to: introduce a harmonised protocol for Bsal detection throughout the EU; improve data acquisition on salamander abundance and distribution; enhance passive surveillance activities; increase public and professionals’ awareness; condition any movement of captive salamanders on Bsal known health status.