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Abstract EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases, which may be present in different epidemiological study designs. It then describes key epidemiological concepts relevant for evidence appraisal. This includes brief explanations for measures of association, exposure assessment, statistical inference, systematic error and effect modification. The guidance then describes the concept of external validity and the principles of appraising epidemiological studies. The customisation of the study appraisal process is explained including tailoring of tools for assessing the risk of bias (RoB). Several examples of appraising experimental and observational studies using a RoB tool are annexed to the document to illustrate the application of the approach. The latter part of this guidance focuses on different steps of evidence integration, first within and then across different streams of evidence. With respect to risk characterisation, the guidance considers how evidence from human epidemiological studies can be used in dose–response modelling with several different options being presented. Finally, the guidance addresses the application of uncertainty factors in risk characterisation when using evidence from human epidemiological studies.

Abstract EFSA Strategy 2027 outlines the need for fit‐for‐purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the ‘Draft framework for protocol development for EFSA's scientific assessments’ published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub‐questions is proposed: the ‘APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross‐cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub‐questions, including uncertainty analysis. Five possible approaches to answering individual (sub‐)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi‐formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and – not covered in this guidance – generating empirical evidence ex novo. The guidance is complemented by a standalone ‘template’ for EFSA protocols that guides the users step by step through the process of planning an EFSA scientific assessment.

Abstract In the context of the initiative ‘CP‐g‐22‐04.01 Direct grants to Member States’ authorities', EFSA was requested to develop and conduct a prioritisation of zoonotic diseases, in collaboration with Member States, to identify priorities for the establishment of a coordinated surveillance system under the One Health approach. The methodology developed by EFSA's Working Group on One Health surveillance was based on a combination of multi‐criteria decision analysis and the Delphi method. It comprised the establishment of a list of zoonotic diseases, definition of pathogen‐ and surveillance‐related criteria, weighing of those criteria, scoring of zoonotic diseases by Member States, calculation of summary scores, and ranking of the list of zoonotic diseases according to those scores. Results were presented at EU and country level. A prioritisation workshop was organised with the One Health subgroup of EFSA's Scientific Network for Risk Assessment in Animal Health and Welfare in November 2022 to discuss and agree on a final list of priorities for which specific surveillance strategies would be developed. Those 10 priorities were Crimean‐Congo haemorrhagic fever, echinococcosis (both E. granulosus and E. multilocularis), hepatitis E, influenza (avian), influenza (swine), Lyme borreliosis, Q‐fever, Rift Valley fever, tick‐borne encephalitis and West Nile fever. ‘Disease X' was not assessed in the same way as other zoonotic diseases on the list, but it was added to the final list of priorities due to its relevance and importance in the One Health context.

Abstract This report provides guidance for Member states who plan to submit applications under the work programme ‘CP‐g‐22‐04.01 Direct grants to Member States' authorities’. The priority pathogens on which the coordinated surveillance under the grant initiative shall focus have been identified in a prioritisation exercise with Member States and ECDC. These are Crimean Congo haemorrhagic fever, echinococcosis, hepatitis E, highly pathogenic avian influenza (HPAI), influenza in swine, Lyme disease, Q‐fever, Rift Valley fever, tick‐borne encephalitis, West Nile fever and Disease X (Disease Y of animals). Surveillance activities (surveillance cards) have been proposed for these agents in this report. Member States should select one or more diseases from the list of priority diseases and then choose surveillance activities from the surveillance cards and modify them where needed, to reflect their national needs and situation. Member States can also design alternative surveillance activities for the priority infectious agents that may better fit the epidemiological situation in their country. Further, this report provides a section on surveillance perspectives that links infectious agents to different hosts, allowing Member States to consider the testing for multiple infectious agents in samples from a single host population, as well as sections providing guidance on surveillance in vectors and wildlife and for Disease X (Disease Y in animals). Member States are encouraged to develop cross‐sectoral collaborations and the report provides guidance on cross‐sectoral collaboration to help them. Finally, there is a roadmap providing an overall description of the steps in the process of developing a surveillance system in order to apply for the grant.

Abstract EFSA received a mandate from the European Commission to assess the effectiveness of prohibitions of certain activities in restricted zones, and of certain risk mitigation treatments for products of animal origin and other materials with respect to diseases included in the Category A list in the Animal Health Law (Regulation (EU) 2016/429). This opinion belongs to a series of opinions where other disease‐specific control measures have been assessed. In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of (i) prohibiting the movements of certain products, notably germinal products (semen, oocytes, embryos and hatching eggs), products of animal origin and animal by‐products and feed of plant origin, hay and straw, and (ii) risk mitigation treatments for products of animal origin. In terms of semen, oocytes, embryos and hatching eggs, it was agreed that there was a lack of evidence particularly for embryos and oocytes reflected in a varying degree of uncertainty, whether these commodities could potentially contain the pathogen under consideration. The scenario assessed did not consider whether the presence of pathogen would lead to infection in the recipient animal. In terms of animal products, certain animal by‐products and movement of feed of plant origin and straw, the assessment considered the ability of the commodity to transmit disease to another animal if exposed. For most pathogens, products were to some degree considered a risk, but lack of field evidence contributed to the uncertainty, particularly as potential exposure of ruminants to meat products is concerned. In terms of the risk mitigating treatments, recommendations have been made for several of these treatments, because the treatment description is not complete, the evidence is poor or inconclusive, or the evidence points to the treatment being ineffective.

Abstract The EFSA asked the Panel on Animal Health and Welfare to develop a guidance document on good practice in conducting scientific assessments in animal health using modelling. In previous opinions, the AHAW Panel has responded to two‐thirds of animal health‐related mandates using some kind of modelling. These models range from simple to complex, employing a combination of scientific, economic, socio‐economic or other types of data. Hence, there is strong interest in the development of a guidance document to integrate modelling efforts into the routine process of EFSA working groups. In this document, an ‘operating procedure' (OP) for the use of modelling within an AH working group is presented. The OP provides a detailed flowchart enabling modelling to be transparently and consistently integrated in the assessment. The OP is structured into phases. These phases combine the relevant standard operating procedures and working instructions of EFSA with the modelling process. Each phase includes roles and actions to be taken, expected output and the sequence of agreements that need to be made between all partners in the scientific assessment. In conclusion, it is expected that adherence to the OP will improve transparency of models in EFSA outputs, and it is recommended to adopt it as a standard procedure when responding to AHAW mandates.

Abstract EFSA received a mandate from the European Commission to assess the effectiveness of 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 rinderpest (RP), the only animal disease to have been globally eradicated. In this opinion, the AHAW Panel 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. The transmission kernels used for the assessment of the minimum radius of the protection and surveillance zones are shown. Several scenarios for which control measures had to be assessed were agreed prior to the assessment. Considering that RP has been eradicated globally, a re‐emergence that is not stopped in its early phases could have a devastating impact on animal health and the economy. The panel concludes that no suitable strategies are available to entirely mitigate the risk associated with granting derogations from killing of animals in an affected establishment or for animal movements. Therefore, the panel recommends to not grant any derogations. The monitoring period of 21 days was assessed as effective, except for the hypothetical first re‐emergence of RP, when lack of awareness and diagnostic capability may extend the time to detection. It was concluded that the protection and the surveillance zones would contain 90% and > 99%, respectively, of the infections from an affected establishment. Enlarging the protection zone to 4 km would contain the disease spread with 95% probability.

Abstract 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.

Abstract This opinion assesses the risk posed by different matrices to introduce African swine fever virus (ASFV) to non‐affected regions of the EU. Matrices assessed are feed materials, enrichment/bedding materials and empty live pigs transport vehicles returning from affected areas. Although the risk from feed is considered to be lower than several other pathways (e.g. contact with infected live animals and swill feeding), it cannot be ruled out that matrices assessed in this opinion pose a risk. Evidence on survival of ASFV in different matrices from literature and a public consultation was used in an Expert Knowledge Elicitation (EKE) on the possible contamination of products and traded or imported product volumes used on pig farms. The EKE results were used in a model that provided a risk‐rank for each product's contamination likelihood (‘q’), its trade or import volume from affected EU or Eurasian areas (N) and the modelled number of potentially infected pig farms (N × q). The products ranking higher regardless of origin or destination were mash and pelleted compound feed, feed additives and cereals. Bedding/enrichment materials, hydrolysed proteins and blood products ranked lowest regardless of origin or destination. Empty vehicles ranked lower than compound feed but higher than non‐compound feed or bedding/enrichment material. It is very likely (95–99% certainty) that compound feed and cereals rank higher than feed materials, which rank higher than bedding/enrichment material and forage. As this is an assessment based on several parameters including the contamination and delivery to a pig farm, all of which have the same impact on the final ranking, risk managers should consider how the relative rank of each product may change with an effective storage period or a virus inactivation step.

Abstract EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases of the different epidemiological study designs. It describes key epidemiological concepts relevant for evidence appraisal. Regarding study reliability, measures of association, exposure assessment, statistical inferences, systematic error and effect modification are explained. Regarding study relevance, the guidance describes the concept of external validity. The principles of appraising epidemiological studies are illustrated, and an overview of Risk of Bias (RoB) tools is given. A decision tree is developed to assist in the selection of the appropriate Risk of Bias tool, depending on study question, population and design. The customisation of the study appraisal process is explained, detailing the use of RoB tools and assessing the risk of bias in the body of evidence. Several examples of appraising experimental and observational studies using a Risk of Bias tool are annexed to the document to illustrate the application of the approach. This document constitutes a draft that will be applied in EFSA's assessments during a 1‐year pilot phase and be revised and complemented as necessary. Before finalisation of the document, a public consultation will be launched.

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. To take better account of the uncertainties involved, a quantitative instead of a categorical approach has been followed from 2021. The output henceforth consists in the individual probability ranges provided by the experts and their computed median range.

Abstract African swine fever virus (ASFV) has been notified in the Baltic countries and the eastern part of Poland from the beginning of 2014 up to now. In collaboration with the ASF‐affected Member States (MS), EFSA is updating the epidemiological analysis of ASF in the European Union which was carried out in 2015. For this purpose, the latest epidemiological and laboratory data were analysed in order to identify the spatial–temporal pattern of the epidemic and a risk factors facilitating its spread. Currently, the ASF outbreaks in wild boar in the Baltic countries and Poland can be defined as a small‐scale epidemic with a slow average spatial spread in wild boar subpopulations (approximately from 1 in Lithuania and Poland to 2 km/month in Estonia and Latvia). The number of positive samples in hunted wild boar peaks in winter which can be explained by human activity patterns (significant hunting activity over winter). The number of positive samples in wild boar found dead peaks in summer. This could be related to the epidemiology of the disease and/or the biology of wild boar; however, this needs further investigation. Virus prevalence in hunted wild boar is very low (0.04–3%), without any apparent trend over time. Apparent virus prevalence at country level in wild boar found dead in affected countries ranges from 60% to 86%, with the exception of Poland, where values between 0.5% and 1.42%, were observed. Since the beginning of the epidemic, the apparent antibody prevalence in hunted wild boar has always been lower than the apparent virus prevalence, indicating an unchanged epidemiological/immunological situation. The risk factor analysis shows an association between the number of settlements, human and domestic pigs population size or wild boar population density and the presence of ASF in wild boar for Estonia, Latvia and Lithuania.

Abstract A new fungus, Batrachochytrium salamandrivorans (Bsal), was identified in wild populations of salamanders in the Netherlands and Belgium, and in kept salamander populations in Germany and the United Kingdom. EFSA assessed the potential of Bsal to affect the health of wild and kept salamanders in the EU, the effectiveness and feasibility of a movement ban of traded salamanders, the validity, reliability and robustness of available diagnostic methods for Bsal detection, and possible alternative methods and feasible risk mitigation measures to ensure safe international and EU trade of salamanders and their products. Bsal was isolated and characterised in 2013 from a declining fire salamander (Salamandra salamandra) population in the Netherlands. Based on the available evidence, it is likely that Bsal is a sufficient cause for the death of S. salamandra both in the laboratory and in the wild. Despite small sample sizes, the available experimental evidence indicates that Bsal is associated with disease and death in individuals of 12 European and 3 Asian salamander species, and with high mortality rate outbreaks in kept salamanders. Bsal experimental infection was detected in individuals of at least one species pertaining to the families Salamandridae, Plethodontidae, Hynobiidae and Sirenidae. Movement bans constitute key risk mitigation measures to prevent pathogen spread into naïve areas and populations. The effectiveness of a movement ban is mainly dependent on the import volumes, possibility of Bsal to remain viable outside susceptible/tolerant species, and the capacity to limit illegal movements. Duplex real‐time PCR can be used to detect Bsal DNA, but has not been fully validated. Quarantining salamanders, enacting legislation that requires testing of animals to demonstrate freedom from Bsal, before movement can take place, restricting salamander movements, tracking all traded species, hygienic procedures/biosecurity measures before and during movements, and increasing public awareness are relevant measures for ensuring safe intra‐EU and international trade of salamanders.