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Executive summary When investigating and controlling outbreaks caused by zoonotic avian influenza viruses (AIV), a One Health approach is key. However, knowledge‐sharing on AIV‐specific One Health strategies, tools and action plans remains limited across the EU/EEA. It is crucial to establish responsibilities, capacity requirements, and collaboration mechanisms during 'peace time' to enable timely and effective outbreak investigations and management. This report focuses on five scenarios for outbreak investigation and management of zoonotic AIV at the human‐animal‐environment interface, emphasising key actions for the stakeholders involved. The document primarily highlights the collaborative framework necessary for interdisciplinary coordinated responses, referring to more detailed guidance and technical reports published elsewhere when applicable. Three scenarios are triggered by suspected outbreaks in animals, including kept animals of listed species, non‐listed species, companion animals and wild birds/mammals. The other two scenarios are initiated by a probable human case or detection of the virus in wastewater or environmental samples (e.g. surface water or other sources). All scenarios require cross‐sectoral coordination and a One Health approach. While the specific sequence of actions and communication needs may differ across scenarios, the overarching response mechanisms for outbreak investigations and management remain consistent. By presenting each scenario alongside the integrated actions of stakeholders, the report identifies critical development needs, such as tools (e.g. communication and data sharing platforms); key points for information exchange across sectors, triggers for joint risk assessments, and gaps in existing knowledge. The document should assist in developing guidance documents to facilitate coordinated One Health investigations and the management of outbreaks in humans and animals caused by zoonotic avian influenza viruses. This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9191/full

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.

The emergence of highly pathogenic avian influenza (HPAI) A(H5N1), clade 2.3.4.4b, genotype B3.13 in U.S. dairy cattle marks a significant shift in the virus' host range and epidemiological profile. Infected cattle typically exhibit mild clinical signs, such as reduced milk production, mastitis and fever, with morbidity generally below 20% and mortality averaging 2%. Transmission within farms is primarily driven by contaminated milk and milking procedures, while farm‐to‐farm spread is mainly linked to cattle movement and shared equipment. The virus demonstrates high replication in mammary glands, with infected cows shedding large quantities of virus in milk for up to 3 weeks, even in the absence of clinical signs. Shedding through other routes appears limited. Infected cattle develop virus‐specific antibodies within 7–10 days, offering short‐term protection, though the duration and robustness of immunity remain unclear. Between March 2024 and May 2025, the virus was confirmed in 981 dairy herds across 16 U.S. states, with California particularly affected. Risk factors identified for between‐farm spread include cattle movement, shared equipment and contact with external personnel, while biosecurity measures, including waste management and wildlife deterrence, may reduce the risk of virus introduction. In response to the outbreaks, U.S. authorities implemented strict movement controls, mandatory testing and enhanced biosecurity protocols. Potential pathways of introduction of HPAI B3.13 virus into EU via trade from US could be the import of lactating cows and bovine meat, although strict trade regulations, absence of animal import and limited virus detection in meat, especially in muscle tissue, do not support this occurrence. Import of products containing raw milk could also be potential pathways for virus introduction. Migratory birds – particularly waterfowl – pose potential pathways for introduction during seasonal migrations. The detection of mammalian‐adaptive mutations and zoonotic cases underscores the virus' public health relevance and the need for research, surveillance and cross‐sectoral preparedness.

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.

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. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2022.EN-7349/full

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.

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. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6595/full

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.

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. This publication is linked to the following EFSA Supporting Publications articles: http://www.efsa.europa.eu/en/supporting/pub/9993e and http://www.efsa.europa.eu/en/supporting/pub/9994e

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.