Computing metrics to inform selection of candidate areas for a regionalized approach to bovine tuberculosis eradication in Ireland.

We describe the computation of metrics to inform the selection of areas for a regionalised approach to bovine tuberculosis eradication in Ireland. Our aim was not to recommend suitable regions but to elucidate the criteria used in metric selection and comment on the diversity of metric values amongst regions. The 26 counties of Ireland were compared using 20 metrics, grouped into five categories: region size and cattle population, herd fragmentation, cattle movement, bovine TB testing, badger population and control. Fragmentation metrics, measuring the proportion of herds with land in at least two counties, varied considerably by county, from 1% to 24 %.  Between 25 % and 92 % of moves into herds came from a different county, illustrating the likely disruption in trade that a regionalized approach could entail. Cattle movement networks were combined with a risk model to calculate the proportion of moves which would be deemed risky under a risk-based trading regime and these results were compared to a more traditional approach based on the herd type and test history of each herd, with many fewer moves potentially restricted using the latter approach. We show how correlation between region size and some of the metrics complicates their interpretation.

The impact of changing the cut-off threshold of the interferon-gamma (IFN-γ) assay for diagnosing bovine tuberculosis in Ireland.

In Ireland, the interferon-gamma (IFN-γ) assay is routinely used as an ancillary test interpreted in parallel with the single intradermal comparative tuberculin test (SICTT) to maximize the detection of bovine tuberculosis (bTB) infected animals. Up until 2018, a positive test result was recorded in the IFN-γ ELISA assay following whole blood stimulation with purified protein derivative (PPD)-bovine (B), PPD-avian (A) and nil sample (N), using the interpretation criteria, B-N > 50 optical density units (OD), B > 100 and B-A > 0. Following a review of available data, the threshold of the B-A component changed to B-A > 80. As predicting the impact of changing the cut-off thresholds for the IFN-γ test de novo is challenging, the aims of this study were to follow animals that initially tested negative using the new IFN-γ assay interpretation criteria and investigate their future risk of disclosure with bTB, with a focus on animals that otherwise would have been removed when using the older interpretation criteria (0 < B-A ≤ 80). Enrolled animals (n = 28,669 cattle from 527 herds) were followed up for two years (2019-2021), or to point of bTB detection or death. At the end of follow-up, 1151 (4.0%) of enrolled animals were bTB cases. The majority of these cases were diagnosed using SICTT (80.5%). The cumulative number of positive animals that would have been removed if the old cut-off (0 < B-A ≤ 80) was used amounted to 1680 cattle (5.9% of the enrolled cohort). Of these, 127 (7.5%) were diagnosed with bTB during follow-up. In contrast, 1024 of the 1151 cattle which subsequently tested positive during the study period following a negative IFN-γ test would not have been identified with the old or new IFN-γ cut-off criteria. Survival analysis showed that animals that would have been removed under the old interpretation criteria were at increased risk of a positive diagnosis with bTB during follow-up compared to other test negative animals. A newly developed risk prediction model (using a Cox proportional hazard model) showed that age, animal number of SICTT tests, number of inconclusive SICTT tests, B-A (IFN-γ assay), B-N (IFN-γ assay), animals from store herds and the percentage of the rest of the herd that were positive during the breakdown were statistically significantly associated with bTB detection. However, inclusion of the IFN-γ OD variables did not show added value in terms of prediction performance of the model.

Investigation of the association between the Enferplex bovine tuberculosis antibody test and the future risk of bovine tuberculosis in irish cattle in infected herds: a pilot field study.

The Single Intradermal Comparative Tuberculin Test (SICTT) and the interferon-gamma (IFN-γ) assay are the approved diagnostic tests for bovine tuberculosis (bTB) in Ireland. The aim of this pilot study was to explore if there was any added diagnostic benefit from applying the Enferplex bTB test (an antibody test) in severe bTB herd breakdowns after the removal of cattle that had tested positive to the SICTT and the IFN-γ test. In addition to the normal bTB testing and management protocols, the animals in these herds that tested negative to SICTT and the IFN-γ test were followed forward for a period of two years. All animals were tested by Enferplex at enrolment. The time to subsequent bTB detection (diagnosed with SICTT/IFN-γ tests or detection of visible lesions at routine slaughter) for animals that tested positive or negative to the Enferplex bTB test at the start of the study was compared using Kaplan-Meier survival curves and Cox based survival models. Of the 484 enrolled animals (from 11 herds), 171 (35.3%) and 151 (31.1%) initially tested positive in the Enferplex assay under the high sensitivity and high specificity interpretation settings respectively. The results of the survival analysis showed that there was no difference in the survival time to a positive diagnosis with bTB during the follow-up period between animals initially classified as positive and negative by the Enferplex test. Further research is warranted to explore the potential benefit of using the Enferplex test in other scenarios.

Guidance on protocol development for EFSA generic scientific assessments.

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.

The opinions of farm animal veterinarians in Ireland on antibiotic use and their role in antimicrobial stewardship.

BACKGROUND: Antibiotic use and resistance in animal production are a concern to public health, and there is an urgent need to reduce antibiotic use in farm animals. To prevent blame shifting, professionals from human medicine, animal medicine and environmental backgrounds must collaborate to tackle this issue. Veterinarians are typically responsible for overseeing and prescribing antibiotic use in animals. There are currently no available studies on the opinions of Irish farm animal veterinarians on antibiotic use, reduction opportunities and their relationships with farmers. A digital survey was developed and sent out to Irish farm animal veterinarians. This paper presents the results of a cross-sectional study of Irish farm animal veterinarians' attitudes towards antimicrobial stewardship, their prescribing behaviours, antibiotic reduction opportunities and their attitudes for the future of antibiotic use. The veterinarian-farmer relationship is examined and potential interventions to reduce antibiotic use on farms are identified. RESULTS: In total, 114 complete questionnaires were received, representing approximately 11 per cent of all farm animal veterinarians in Ireland. Respondents were aware of the problem of antibiotic resistance and recognise their role in the fight against it. They realise what actions they must take to reduce antibiotic use and identify barriers that prevent their farmer clients from implementing their advice. Many of them say that they can reduce antibiotic use on farms in the future, but some remain doubtful. There was no statistical difference between veterinarians that had less experience working than those that had more experience in their attitudes towards future reduction in antibiotic use. CONCLUSION: Most of the respondents seek to use antibiotics as judiciously as they can. The majority agree that antibiotic overuse is the main contributor to antibiotic resistance. Possible solutions to reduce antibiotic use include the development of antibiotic treatment guidelines, assigning one unique practice to each farm and compulsory CPD (Continuous Professional Development) courses.

Inferring bovine tuberculosis transmission between cattle and badgers via the environment and risk mapping.

Bovine tuberculosis (bTB), caused by Mycobacterium bovis, is one of the most challenging and persistent health issues in many countries worldwide. In several countries, bTB control is complicated due to the presence of wildlife reservoirs of infection, i.e. European badger (Meles meles) in Ireland and the UK, which can transmit infection to cattle. However, a quantitative understanding of the role of cattle and badgers in bTB transmission is elusive, especially where there is spatial variation in relative density between badgers and cattle. Moreover, as these two species have infrequent direct contact, environmental transmission is likely to play a role, but the quantitative importance of the environment has not been assessed. Therefore, the objective of this study is to better understand bTB transmission between cattle and badgers via the environment in a spatially explicit context and to identify high-risk areas. We developed an environmental transmission model that incorporates both within-herd/territory transmission and between-species transmission, with the latter facilitated by badger territories overlapping with herd areas. Model parameters such as transmission rate parameters and the decay rate parameter of M. bovis were estimated by maximum likelihood estimation using infection data from badgers and cattle collected during a 4-year badger vaccination trial. Our estimation showed that the environment can play an important role in the transmission of bTB, with a half-life of M. bovis in the environment of around 177 days. Based on the estimated transmission rate parameters, we calculate the basic reproduction ratio (R) within a herd, which reveals how relative badger density dictates transmission. In addition, we simulated transmission in each small local area to generate a first between-herd R map that identifies high-risk areas.

A mixed-method survey to understand the role of dog welfare organisations in Ireland, including reported challenges and potential solutions.

BACKGROUND: This novel study forms part of a larger research programme seeking an improved understanding of aspects of the owned dog population in Ireland. Dog welfare organisations (DWOs) in Ireland are recognised as an instrumental pillar of the animal welfare sector with some receiving substantial public funding. We conducted a survey of DWOs in Ireland (n = 39) to gain a better understanding of their role and function, including their policies and procedures and the rehoming of dogs to other regions. In addition, we wanted to get a better understanding of the challenges experienced by DWOs in fulfilling their role and their perspectives on potential solutions to these challenges. The survey questions consisted of closed and open-ended items. Closed items were analysed quantitively; open-ended items were analysed thematically. RESULTS: Most DWOs (> 80%) had written protocols for important welfare actions including rehoming procedures, assessment of owner suitability and euthanasia. DWOs sent dogs to Northern Ireland (13%), Great Britain (38.5%) and to other countries outside the United Kingdom (36%, including Germany, Sweden, Italy, the Netherlands and Czechia). Reported challenges included a general lack of funding, limited public awareness of the importance of dog welfare and insufficient capacity to handle dog numbers. To address these challenges, the DWOs highlighted the potential contribution of subsidised programmes and access to resources to educate potential owners. In a further qualitative evaluation to capture perceptions of appropriate solutions by DWOs, several themes emerged, relating to legislation, education, an overwhelmed workforce, and funding. CONCLUSIONS: This study provides important insights into the roles and functions of DWOs and challenges they experience in Ireland. It is hoped that the findings from this research will inform future research investigating potential solutions to these challenges as well as the development of policy in Ireland.

bTB eradication in Ireland: where to from here?

BACKGROUND: In an earlier paper from 2019, this author concluded that successful eradication of bovine tuberculosis (bTB) from Ireland by 2030 would be unlikely, given control strategies in place at that time plus the addition of badger vaccination. He argued that additional measures will be needed, broadly focusing on bTB risks from wildlife, risk-based cattle controls, and industry commitment. This paper considers these points in further detail. MAIN TEXT: Ongoing monitoring of the badger vaccination programme (which is progressively being rolled out nationally) and associated research will be critical, with a focus both on programme inputs and outcomes. The direct contribution of cattle movements to bTB restrictions in Ireland has been evaluated. However, it is the indirect role of cattle movements in bTB restrictions that is likely of greater importance, particularly towards the latter phase of the eradication programme. In other national programmes, a range of risk-based approaches have been used to address the challenge of residual infection in cattle (that is, the presence of animals with persistent but undetected infection), and similar approaches are needed in Ireland. A number of authors have highlighted the critical importance of industry commitment to programme success, and the key role of programme governance to achieving this. In this commentary, the author briefly considers experiences from Australia and New Zealand in this regard. The author also reflects on the challenge of uncertainty in decision-making, the relevance to Ireland of lessons from other countries, and the potential contribution of new methodologies in support of the national programme. CONCLUSIONS: 'The tragedy of the horizon' was a term first used in the context of climate change, referring to the costs imposed on future generations that the current generation has no direct incentives to fix. This concept is equally relevant to bTB eradication in Ireland, where current decisions will have long-term consequences for future generations, including both the general public (through the Exchequer) and future Irish farmers.

An observational study of ear-tagged calf mortality (1 to 100 days) on Irish dairy farms and associations between biosecurity practices and calf mortality on farms participating in a Johne's disease control program.

Postnatal mortality among replacement stock has a detrimental effect on the social, economic, and environmental sustainability of dairy production. Calf mortality rates vary between countries and show differences in temporal trends; most, however, are characterized by high levels of between-farm variability. Explaining this variation can be difficult because herd-level information on management practices relevant to calf health is often not available. The Irish Johne's Control Programme (IJCP) contains a substantial on-farm monitoring program called the Veterinary Risk Assessment and Management Plan (VRAMP). Although this risk assessment is largely focused on factors relevant to the transmission of paratuberculosis, many of its principles are good practice biocontainment policies that are also advocated for the protection of calf health. The objectives of this study were (1) to quantify mortality in ear-tagged Irish dairy calves between 2016 and 2020 using both survival and risk approaches, (2) to determine risk factors for 100-d cumulative mortality hazard in ear-tagged Irish dairy calves between 2016 and 2020, (3) to determine whether 100-d cumulative mortality hazard was higher in ear-tagged calves within herds registered in the IJCP versus those that were not registered in the IJCP and whether there were differences between these cohorts over time, and (4) within IJCP herds, to determine whether VRAMP score or changes in VRAMP score were associated with 100-d cumulative mortality hazard. Excluding perinatal mortality, the overall 100-d cumulative mortality hazard was 4.1%. Calf mortality was consistently underestimated using risk approaches that did not account for calf censoring. Cox proportional hazards models showed that cumulative mortality hazard was greater in male calves; particularly, calves born to Jersey breed dams and those with a beef breed sire. Mortality hazard increased with increasing herd size, was highest in calves born in herds that contract-reared heifers, and lowest in those born in mixed dairy-beef enterprises. Mortality hazard decreased over time with the mortality hazard in 2020 being 0.83 times that of 2016. Mortality hazard was higher in IJCP-registered herds than nonregistered herds (hazard ratio 1.06, 95% CI 1.01-1.12), likely reflecting differences in herds that enrolled in the national program. However, we detected a significant interaction between IJCP status (enrolled vs. not enrolled) and year (hazard ratio 0.96, 95% CI 0.92-1.00), indicating that the decrease in mortality hazard between 2016 and 2020 was greater in IJCP herds versus non-IJCP herds. Finally, increasing VRAMP scores (indicating higher risk for paratuberculosis transmission) were positively associated with increased calf mortality hazard. Postnatal calf mortality rates in Irish dairy herds declined between 2016 and 2020. Our study suggests that implementation of recommended biocontainment practices to control paratuberculosis in IJCP herds was associated with a reduction in calf mortality hazard.

Seeing our hand or a tool during visually-guided actions: Different effects on the somatosensory and visual cortices.

The processing of proprioceptive information in the context of a conflict between visual and somatosensory feedbacks deteriorates motor performance. Previous studies have shown that seeing one's hand increases the weighting assigned to arm somatosensory inputs. In this light, we hypothesized that the sensory conflict, when tracing the contour of a shape with mirror-reversed vision, will be greater for participants who trace with a stylus seen in their hand (Hand group, n = 17) than for participants who trace with the tip of rod without seen their hand (Tool group, n = 15). Based on this hypothesis, we predicted that the tracing performance with mirror vision will be more deteriorated for the Hand group than for the Tool group, and we predicted a greater gating of somatosensory information for the Hand group to reduce the sensory conflict. The participants of both groups followed the outline of a shape in two visual conditions. Direct vision: the participants saw the hand or portion of a light 40 cm rod directly. Mirror Vision: the hand or the rod was seen through a mirror. We measured tracing performance using a digitizing tablet and the cortical activity with electroencephalography. Behavioral analyses revealed that the tracing performance of both groups was similarly impaired by mirror vision. However, contrasting the spectral content of the cortical oscillatory activity between the Mirror and Direct conditions, we observed that tracing with mirror vision resulted in significantly larger alpha (8-12 Hz) and beta (15-25 Hz) powers in the somatosensory cortex for participants of the Hand group. The somatosensory alpha and beta powers did not significantly differ between Mirror and Direct vision conditions for the Tool group. For both groups, tracing with mirror vision altered the activity of the visual cortex: decreased alpha power for the Hand group, decreased alpha and beta power for the Tool group. Overall, these results suggest that seeing the hand enhanced the sensory conflict when tracing with mirror vision and that the increase of alpha and beta powers in the somatosensory cortex served to reduce the weight assigned to somatosensory information. The increased activity of the visual cortex observed for both groups in the mirror vision condition suggests greater visual processing with increased task difficulty. Finally, the fact that the participants of the Tool group did not show better tracing performance than those of the Hand group suggests that tracing deterioration resulted from a sensorimotor conflict (as opposed to a visuo-proprioceptive conflict).

Re-evaluation of the existing health-based guidance values for copper and exposure assessment from all sources.

Copper is an essential micronutrient and also a regulated product used in organic and in conventional farming pest management. Both deficiency and excessive exposure to copper can have adverse health effects. In this Scientific Opinion, the EFSA 2021 harmonised approach for establishing health-based guidance values (HBGVs) for substances that are regulated products and also nutrients was used to resolve the divergent existing HBGVs for copper. The tightly regulated homeostasis prevents toxicity manifestation in the short term, but the development of chronic copper toxicity is dependent on copper homeostasis and its tissue retention. Evidence from Wilson disease suggests that hepatic retention is indicative of potential future and possibly sudden onset of copper toxicity under conditions of continuous intake. Hence, emphasis was placed on copper retention as an early marker of potential adverse effects. The relationships between (a) chronic copper exposure and its retention in the body, particularly the liver, and (b) hepatic copper concentrations and evidence of toxicity were examined. The Scientific Committee (SC) concludes that no retention of copper is expected to occur with intake of 5 mg/day and established an Acceptable Daily Intake (ADI) of 0.07 mg/kg bw. A refined dietary exposure assessment was performed, assessing contribution from dietary and non-dietary sources. Background copper levels are a significant source of copper. The contribution of copper from its use as plant protection product (PPP), food and feed additives or fertilisers is negligible. The use of copper in fertilisers or PPPs contributes to copper accumulation in soil. Infant formula and follow-on formula are important contributors to dietary exposure of copper in infants and toddlers. Contribution from non-oral sources is negligible. Dietary exposure to total copper does not exceed the HBGV in adolescents, adults, elderly and the very elderly. Neither hepatic copper retention nor adverse effects are expected to occur from the estimated copper exposure in children due to higher nutrient requirements related to growth.

Can Ingoing Contact Chains and other cattle movement network metrics help predict herd-level bovine tuberculosis in Irish cattle herds?

We used logistic regression to investigate whether the risk of an Irish cattle herd undergoing a bovine tuberculosis (bTB) breakdown increased with the size of the Ingoing Contact Chain (ICC) of previous herd to herd cattle movements, in a sequence up to eight moves back from the most recent, direct, movement into the herd. We further examined whether taking into account the bTB test history of each herd in the chain would improve model fit. We found that measures of cattle movements directly into the herd were risk factors for subsequent bTB restrictions, and the number of herds that animals were coming from was the most important of these. However, in contrast to a previous study in Great Britain, the ICC herd count at steps more remote than direct movements into the herd did not result in better fitting models than restricting the count to direct movements. Restricting the ICC counts to herds which had previously or would in the future test positive for bTB resulted in improved model fits, but this was not the case if only the previous test status was considered. This suggests that in many cases bTB infected animals are moving out of herds before being identified through testing, and that risk-based trading approaches should not rely solely on the previous test history of source herds as a proxy for future risk. Model fit was also improved by the inclusion of variables measuring bTB history of the herd, bTB in neighbouring herds, herd size, herd type, the movement network measures "in strength" and "betweenness", altitude, modelled badger abundance and county. Rainfall was not a good predictor. The most influential measures of bTB in nearby herds (a proxy for neighbourhood infection) were the proportion of herds with a history of bTB whose centroids were within 6 km, or whose boundaries were within 4 km, of the index herd. As well as informing national control and surveillance measures, our models can be used to identify areas where bTB rates are anomalously high, to prompt further investigation in these areas.

A Qualitative Exploration of Challenges and Opportunities for Dog Welfare in Ireland Post COVID-19, as Perceived by Dog Welfare Organisations.

This novel qualitative study identifies challenges and opportunities to improve dog welfare in Ireland, as perceived by dog welfare organisations (DWOs), a previously underutilised stakeholder. This study sought the views of this predominantly voluntary sector of the next steps for policy and action in dog welfare, in light of the effects of the "puppy pandemic", increased costs and COVID-19 restrictions. An integrated online focus group and interview design involving DWOs was analysed using inductive thematic analysis. Thematic analysis identified 2 key themes: (1) Key challenges and solutions in general dog welfare and (2) Challenges and opportunities in the welfare organisation sector. DWOs perceived poor public awareness of appropriate dog-husbandry, inadequate legislation enforcement, negative impact of puppy farms, and increased financial and volunteer burden. DWOs helped construct a best practice rehoming pathway, identified how overall standards could be improved and recommendations to enhance dog welfare. The DWOs perceived an increased numbers of households acquiring dogs, difficulties in rehoming, and financial challenges as threatening their viability as organisations and Irish dog welfare. Greater enforcement of legislation, greater communication between organisations and the government, and more media awareness were seen as helpful by the DWOs to improve dog welfare standards and their organisations.

Prescribing and sales of intramammary antimicrobials in Ireland in 2019 and 2020: the role of milk purchasers.

BACKGROUND: In Ireland between 2008 and 2022, intramammary antimicrobial (AM) products could be prescribed by a veterinary practitioner under what was known as Schedule 8 (or remote) prescribing. Under this prescribing route, an annual herd visit was not required when criteria were met as outlined in Animal Remedies Regulation 2007 to 2017 (statutory instruments No. 786/2007 and 558/2017). Under this prescribing route, the responsibilities of the milk purchaser, the farmer and the veterinary practitioner were each outlined, and a written mastitis control programme (MCP) was required. Milk purchasers implemented MCPs on participating farms (so-called MCP herds) with support from veterinary practitioner(s) who undertook Schedule 8 prescribing of intramammary AM tubes. This study seeks a clearer understanding of the role of milk purchasers in the prescribing and sale of intramammary AM products in Ireland during 2019 and 2020, whilst this Regulation was in force. Specifically, the study sought insights into the role of milk purchasers in the prescribing and sale of intramammary AM products in the Irish dairy industry during 2019 and 2020, using anonymised and highly aggregated milk purchaser data. The study also provided insights into milk quality among supplying herds during this period. METHODS: For this study, we had access to anonymised, highly aggregated data from all milk purchasers that operated a MCP on at least some of their supplying herds during 2019 or 2020. Data collection was undertaken by the Department of Agriculture, Food and Marine. Data analysis was primarily descriptive. RESULTS: Data were available on 11 milk purchasers (64.7% of all) and 13,251 supplying herds. Of these, 52% were MCP herds. The quality of milk from supplying herds varied significantly by month, year and milk purchaser. During 2019 and 2020, there was a single Schedule 8 prescriber (a private veterinary practitioner prescribing intramammary AMs as part of a MCP), on average, for 549.3 herds. The sale of intramammary AM products through milk purchasers represented 15.2% and 26.9% of national sales in in-lactation and dry cow tubes, respectively. There was an overall 2% increase in sales through milk purchasers between 2019 and 2020. Few European Medicines Agency (EMA) category B ('Restrict') intramammary AM products were sold by milk purchasers. For both in-lactation and dry cow tubes, there was a statistically significant association between EMA classification and route of sale (through milk purchasers or otherwise). CONCLUSIONS: The study findings provide important insights into mastitis control and intramammary AM stewardship in the Irish dairy industry. Significant differences between milk purchasers were observed in the quality of milk, as measured through somatic cell count (SCC) values, from supplying herds. This warrants further research. In the context of intramammary AM prescribing, veterinary oversight under the Animal Remedies Regulation 2007 to 2017 was very limited during 2019 and 2020. There were also significant associations between EMA classification and route of sale during 2019 and 2020, reinforcing the need for Irish veterinary practitioners to move away from EMA category B intramammary AMs. Higher quality data are needed to address important industry questions. Specifically it is recommended that national bulk tank SCC data are made available for public good research. Past experiences with Schedule 8 prescribing (no longer permitted from 28 January 2022) may influence current efforts towards improved intramammary AM stewardship.

Guidance on the use of the benchmark dose approach in risk assessment.

The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no-observed-adverse-effect-level (NOAEL) approach for deriving a Reference Point (RP). The major change compared to the previous Guidance (EFSA SC, 2017) concerns the Section 2.5, in which a change from the frequentist to the Bayesian paradigm is recommended. In the former, uncertainty about the unknown parameters is measured by confidence and significance levels, interpreted and calibrated under hypothetical repetition, while probability distributions are attached to the unknown parameters in the Bayesian approach, and the notion of probability is extended to reflect uncertainty of knowledge. In addition, the Bayesian approach can mimic a learning process and reflects the accumulation of knowledge over time. Model averaging is again recommended as the preferred method for estimating the BMD and calculating its credible interval. The set of default models to be used for BMD analysis has been reviewed and amended so that there is now a single set of models for quantal and continuous data. The flow chart guiding the reader step-by-step when performing a BMD analysis has also been updated, and a chapter comparing the frequentist to the Bayesian paradigm inserted. Also, when using Bayesian BMD modelling, the lower bound (BMDL) is to be considered as potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re-evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 or 2017 Guidance was used, in particular when the exposure is clearly lower (e.g. more than one order of magnitude) than the health-based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the wide application of the BMD approach.

Evaluation of existing guidelines for their adequacy for the food and feed risk assessment of microorganisms obtained through synthetic biology.

EFSA was asked by the European Commission to evaluate synthetic biology (SynBio) developments for agri-food use in the near future and to determine whether or not they are expected to constitute potential new hazards/risks. Moreover, EFSA was requested to evaluate the adequacy of existing guidelines for risk assessment of SynBio and if updated guidance is needed. The scope of this Opinion covers food and feed risk assessment, the variety of microorganisms that can be used in the food/feed chain and the whole spectrum of techniques used in SynBio. This Opinion complements a previously adopted Opinion with the evaluation of existing guidelines for the microbial characterisation and environmental risk assessment of microorganisms obtained through SynBio. The present Opinion confirms that microbial SynBio applications for food and feed use, with the exception of xenobionts, could be ready in the European Union in the next decade. New hazards were identified related to the use or production of unusual and/or new-to-nature components. Fifteen cases were selected for evaluating the adequacy of existing guidelines. These were generally adequate for assessing the product, the production process, nutritional and toxicological safety, allergenicity, exposure and post-market monitoring. The comparative approach and a safety assessment per se could be applied depending on the degree of familiarity of the SynBio organism/product with the non-genetically modified counterparts. Updated guidance is recommended for: (i) bacteriophages, protists/microalgae, (ii) exposure to plant protection products and biostimulants, (iii) xenobionts and (iv) feed additives for insects as target species. Development of risk assessment tools is recommended for assessing nutritional value of biomasses, influence of microorganisms on the gut microbiome and the gut function, allergenic potential of new-to-nature proteins, impact of horizontal gene transfer and potential risks of living cell intake. A further development towards a strain-driven risk assessment approach is recommended.

Understanding the dog population in the Republic of Ireland: insight from existing data sources?

BACKGROUND: Reliable information about national pet dog populations is an important contributor to informed decision-making, both by governments and national dog welfare organisations. In some countries, there is an improved understanding of aspects of the national pet dog population, but as yet limited published information is available in Ireland. The current study reviews the utility of existing data to inform our understanding of recent changes to the pet dog population in Ireland, including both biological and organisational processes. RESULTS: Based on national data on dog licencing and microchipping registration, pet dog numbers have remained relatively stable in recent years (ie prior to the COVID-19 pandemic). Since 2015, there has been a substantial decrease in the number of dogs managed through dog control centres. Although the completeness of the data are likely variable, there appears to be substantial, and increasing, number of dogs moving from Ireland to other countries, including UK, Sweden, Italy, Germany and Singapore. We also note an increase (albeit much smaller) in the number of dogs being moved into Ireland. CONCLUSIONS: This study highlights the challenges faced when using existing national data to gain insights into the dog population of Ireland. The linking of existing national databases (individual dog identification, dog licencing, dog control statistics) has the potential to improve both the representativeness and accuracy of information about the Irish pet dog population. In the next phases of our work, we will focus on the work of dog welfare organisations, given both the increased role played by these organisations and the substantial public funding that has been committed in this sector.

Modelling transmission of Mycobacterium avium subspecies paratuberculosis between Irish dairy cattle herds.

Bovine paratuberculosis is an endemic disease caused by Mycobacterium avium subspecies paratuberculosis (Map). Map is mainly transmitted between herds through movement of infected but undetected animals. Our objective was to investigate the effect of observed herd characteristics on Map spread on a national scale in Ireland. Herd characteristics included herd size, number of breeding bulls introduced, number of animals purchased and sold, and number of herds the focal herd purchases from and sells to. We used these characteristics to classify herds in accordance with their probability of becoming infected and of spreading infection to other herds. A stochastic individual-based model was used to represent herd demography and Map infection dynamics of each dairy cattle herd in Ireland. Data on herd size and composition, as well as birth, death, and culling events were used to characterize herd demography. Herds were connected with each other through observed animal trade movements. Data consisted of 13 353 herds, with 4 494 768 dairy female animals, and 72 991 breeding bulls. We showed that the probability of an infected animal being introduced into the herd increases both with an increasing number of animals that enter a herd via trade and number of herds from which animals are sourced. Herds that both buy and sell a lot of animals pose the highest infection risk to other herds and could therefore play an important role in Map spread between herds.