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Several studies have demonstrated that predicting complications of preeclampsia up to 48 h before their occurrence enhances clinical management. This predictive ability allows for rational approaches in dealing with groups at high risk of maternal-fetal complications., Objective: This study aims to identify the clinical parameters strongly associated with maternal-fetal complications during preeclampsia in Congolese pregnant women., Method: A descriptive and analytical study was conducted in the provincial city of Kinshasa from July 2018 to December 2021. The study population consisted of pregnant women with preeclampsia in three maternity units in Kinshasa. Determinants of complications were assessed using univariate and multivariate logistic regression., Results: In univariate logistic regression models, obesity, a history of hypertension, severe hypertension, and SpO 2  < 90 % were identified as determinants of maternal-fetal complications. Conversely, a history of preeclampsia, treatment with MgSO 4 , or a combination of AntiHTA and MgSO 4 reduced the risk of complications. In the multivariate model, after adjusting for all significant variables in the univariate model, severe hypertension, obesity, and SpO 2  < 90 % were identified as independent determinants of maternal-fetal complications. The risk of complication was multiplied by 5 for severe hypertension, by 4 for obesity, and by 2 for SpO 2  < 90 %. However, treating women with MgSO 4 or a combination of AntiHTA and MgSO 4 reduced the risk of complications by a factor of 4 and 6, respectively., Conclusion: The presence of symptoms is more useful in predicting complications of preeclampsia than their absence in ruling out adverse events., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. A study grant was awarded by the alumni of KULeuven., (Copyright © 2024. Published by Elsevier B.V.)

Surfactants are widely used 'down-the-drain' chemicals with the potential to occur at high concentrations in local water bodies and to be part of unintentional environmental mixtures. Recently, increased regulatory focus has been placed on the impacts of complex mixtures in aquatic environments and the substances that are likely to drive mixture risk. This study assessed the contribution of surfactants to the total mixture pressure in freshwater ecosystems. Environmental concentrations, collated from existing French monitoring data, were combined with estimated ecotoxicological thresholds to calculate hazard quotients (HQ) for each substance, and hazard indices (HI) for each mixture. Two scenarios were investigated to correct for concentrations below the limit of quantification (LOQ) in the dataset. The first (best-case) scenario assumed all values

Background: Standard approaches for the assessment of Man via the Environment exposure are designed to be conservative. However, propagating these exposures into health impact assessment might lead to questionable socio-economic costs., Objective: The objective of this study was to develop a novel tiered modelling approach to assess human exposure to lead (Pb) via the environment., Method: The approach starts in Tier 1 from EUSES modelling approach, modified with metal specific transfer factors. The generic Tier 2 approach uses the higher tier model GPM for air quality, and dietary exposure modelling based on EFSA's Comprehensive Food Database, in combination with crop specific transfer factors. Tier 3 considers additional site-specific information such as proximity of inhabitants and agricultural activities in relation to industrial sites., Results: This tiered modelling approach was applied to a case study of 50 lead battery manufacturing and recycling sites across Europe. Data sets from general population human biomonitoring studies were used to compare the predicted additional bioburden of Pb resulting from lead battery manufacturing and recycling. The higher tier assessments were able to demonstrate a >20-fold reduction in modelled Pb exposure compared to default assumptions made in Tier 1., Significance: Leading to better estimates for socio-economic costs in health impact assessment., (© 2021. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Background: The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requires the establishment of Conditions of Use (CoU) for all exposure scenarios to ensure good communication of safe working practices. Setting CoU requires the risk assessment of all relevant Contributing Scenarios (CSs) in the exposure scenario. A new CS has to be created whenever an Operational Condition (OC) is changed, resulting in an excessive number of exposure assessments. An efficient solution is to quantify OC concentrations and to identify reasonable worst-case scenarios with probabilistic exposure modeling. Methods: Here, we appoint CoU for powder pouring during the industrial manufacturing of a paint batch by quantifying OC exposure levels and exposure determinants. The quantification was performed by using stationary measurements and a probabilistic Near-Field/Far-Field (NF/FF) exposure model. Work shift and OC concentration levels were quantified for pouring TiO 2 from big bags and small bags, pouring Micro Mica from small bags, and cleaning. The impact of exposure determinants on NF concentration level was quantified by (1) assessing exposure determinants correlation with the NF exposure level and (2) by performing simulations with different OCs. Results: Emission rate, air mixing between NF and FF and local ventilation were the most relevant exposure determinants affecting NF concentrations. Potentially risky OCs were identified by performing Reasonable Worst Case (RWC) simulations and by comparing the exposure 95 th percentile distribution with 10% of the occupational exposure limit value (OELV). The CS was shown safe except in RWC scenario (ventilation rate from 0.4 to 1.6 1/h, 100 m 3 room, no local ventilation, and NF ventilation of 1.6 m 3 /min). Conclusions: The CoU assessment was considered to comply with European Chemicals Agency (ECHA) legislation and EN 689 exposure assessment strategy for testing compliance with OEL values. One RWC scenario would require measurements since the exposure level was 12.5% of the OELV., Competing Interests: No competing interests were disclosed., (Copyright: © 2021 Koivisto AJ et al.)

The importance of considering the bioavailability of metals in understanding and assessing their toxicity in freshwaters has been recognized for many years. Currently, biotic ligand models (BLMs) are being applied for the derivation and implementation of environmental quality standards (EQS) for metals under the Water Framework Directive in Europe. bio-met is a simplified tool that was developed for implementing bioavailability-based EQS for metals in European freshwaters. We demonstrate the reliability of the relationship between the full BLM predictions and the thresholds (hazardous concentration affecting 5% of species [HC5] values) predicted by bio-met in 3 stages, for the metals copper, nickel, and zinc. First, ecotoxicity data for specific species from laboratory tests in natural waters are compared with predictions by the individual species BLMs included in the full BLMs. Second, the site-specific HC5 values predicted by bio-met for the natural waters used for ecotoxicity testing are compared with those provided by the full BLMs. The reliability of both relationships is demonstrated for all 3 metals, with more than 80% of individual species BLM predictions being within a factor of 3 of the experimental results, and 99% of bio-met local HC5 predictions being within a factor of 2 of the full BLM result. Third, using a larger set of European natural waters in addition demonstrates the reliability of bio-met over a broad range of water chemistry conditions. bio-met is therefore an appropriate tool for performing compliance assessments against EQS values in Europe, due to the demonstrated consistency with the toxicity test data. Environ Toxicol Chem 2020;39:2361-2377. © 2020 SETAC., (© 2020 SETAC.)

We estimated that more than 11,000 people were exposed to highly pathogenic avian influenza viruses in EU/EEA countries over the outbreak period October 2016-September 2018 by cross-linking data submitted by Member States to European Food Safety Authority and EMPRES-i. A stronger framework for collecting human exposure data is required., (© 2019 The Authors. Zoonoses and Public Health published by Blackwell Verlag GmbH.)

Avian influenza viruses infect domestic poultry and wild birds as well as humans. In poultry, depending on whether these viruses are of high pathogenicity (HPAI) or low pathogenicity (LPAI), the infection can cause different clinical signs, with HPAI causing high mortality in poultry flocks. In order to ensure early detection of avian influenza viruses, surveillance in poultry and wild birds is considered essential. In 2010, the European Commission provided some guidelines to Member States (MSs) on how this surveillance should be carried out, both in poultry and wild birds. EFSA received a mandate from the Commission to collate, validate, analyse, and summarise in an annual report the data resulting from the ongoing avian influenza surveillance programmes established in the different MSs. To deliver on this mandate, EFSA, in collaboration with the Standing Working Group on AI, initiated its activities with the drafting of a scientific report where the future vision of this collection framework was presented. Initial and later drafts of this report were shared with MS representatives in order to get feedback on the practicalities concerning the collection and submission of avian influenza surveillance data to EFSA. In the present report, the data that MSs are legally requested to submit to EFSA ('mandatory') and also the data that would be important to collect in order to optimise the outputs ('desirable') are described. A number of actions that would lead to the optimal data collection are also presented and the added value to MSs is discussed. A step-by-step implementation of the outlined actions is anticipated, with a description of the initial collection framework for 2019 being included in this report., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

This update on the African swine fever (ASF) outbreaks in the EU demonstrated that out of all tested wild boar found dead, the proportion of positive samples peaked in winter and summer. For domestic pigs only, a summer peak was evident. Despite the existence of several plausible factors that could result in the observed seasonality, there is no evidence to prove causality. Wild boar density was the most influential risk factor for the occurrence of ASF in wild boar. In the vast majority of introductions in domestic pig holdings, direct contact with infected domestic pigs or wild boar was excluded as the route of introduction. The implementation of emergency measures in the wild boar management zones following a focal ASF introduction was evaluated. As a sole control strategy, intensive hunting around the buffer area might not always be sufficient to eradicate ASF. However, the probability of eradication success is increased after adding quick and safe carcass removal. A wider buffer area leads to a higher success probability; however it implies a larger intensive hunting area and the need for more animals to be hunted. If carcass removal and intensive hunting are effectively implemented, fencing is more useful for delineating zones, rather than adding substantially to control efficacy. However, segments of fencing will be particularly useful in those areas where carcass removal or intensive hunting is difficult to implement. It was not possible to demonstrate an effect of natural barriers on ASF spread. Human-mediated translocation may override any effect of natural barriers. Recommendations for ASF control in four different epidemiological scenarios are presented., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non-commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission to animals and humans. The combined probability of exposure and subsequent LPAIV infection via raw poultry meat containing LPAIV is negligible for commercial poultry and humans exposed via consumption whereas it is very unlikely for non-commercial poultry, wild birds and humans exposed via handling and manipulation. The probability of LPAIV transmission from an individual infected via raw poultry meat containing LPAIV is negligible for commercial poultry and humans, whereas it is very unlikely for non-commercial poultry and wild birds. The combined probability of exposure and subsequent LPAIV infection via raw table eggs containing LPAIV is negligible for commercial poultry and humans and extremely unlikely to negligible for non-commercial poultry and wild birds. The probability of LPAIV transmission from an individual infected via raw table eggs containing LPAIV is negligible for commercial poultry and humans and very unlikely to negligible for non-commercial poultry and wild birds. Although the presence of LPAIV in raw poultry meat and table eggs is very unlikely to negligible, there is in general a high level of uncertainty on the estimation of the subsequent probabilities of key steps of the transmission pathways for poultry and wild birds, mainly due to the limited number of studies available, for instance on the viral load required to infect a bird via raw poultry meat or raw table eggs containing LPAIV., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 EFSA's 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., Competing Interests: 3.2.5Report the sources of funding and the role of the funders for the submitted study. State any potential conflicts of interest., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The European Commission requested EFSA to 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., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Between 16 February and 15 May 2018, three highly pathogenic avian influenza (HPAI) A(H5N6) and 11 HPAI A(H5N8) outbreaks in poultry holdings, one HPAI A(H5N6) and one HPAI A(H5N8) outbreak in captive birds, and 55 HPAI A(H5N6) wild bird events were reported in Europe. There is no evidence to date that HPAI A(H5N6) viruses circulating in Europe are associated with clades infecting humans. Fewer HPAI wild bird cases have been detected than during the same period of previous year. Most of mortality events among wild birds involved single birds and species listed in the revised list of target species for passive surveillance. Raptor species constitute 74% of the HPAI-infected wild birds found dead. Those raptor species probably became infected by hunting or scavenging HPAI virus-positive birds, and so raptor cases may predominate later in the course of an HPAI epidemic. Despite the important HPAI virus incursion via wild birds there have been few associated HPAI A(H5N6) outbreaks in poultry. Fifteen low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. The risk of zoonotic transmission to the general public in Europe is considered to be very low. The situation in Africa and the Middle East should be closely monitored with regards to HPAI A(H5N1) and A(H5N8). Uncontrolled spread of the virus and subsequent further genetic evolution in regions geographically connected to Europe may increase uncertainty and the risk for further dissemination of virus. Long-distance migrating wild birds from southern Africa, e.g. the common tern ( Sterna hirundo ), may be included in targeted active surveillance schemes at a few priority locations in Europe in order to detect HPAI A(H5)-infected migrating birds early. However, the risk of HPAI introduction from non-EU countries via migratory wild birds to Europe is still considered to be much lower for wild birds crossing the southern borders than for those crossing the north-eastern borders., (© 2018 European Food Safety Authority, © European Centre for Disease Prevention and Control, and © European Union Reference Laboratory for Avian Influenza. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Between 16 November 2017 and 15 February 2018, one highly pathogenic avian influenza (HPAI) A(H5N6) and five HPAI A(H5N8) outbreaks in poultry holdings, two HPAI A(H5N6) outbreaks in captive birds and 22 HPAI A(H5N6) wild bird events were reported within Europe. There is a lower incursion of HPAI A(H5N6) in poultry compared to HPAI A(H5N8). There is no evidence to date that HPAI A(H5N6) viruses circulating in Europe are associated with clades infecting humans. Clinical signs in ducks infected with HPAI A(H5N8) seemed to be decreasing, based on reports from Bulgaria. However, HPAI A(H5N8) is still present in Europe and is widespread in neighbouring areas. The majority of mortality events of wild birds from HPAIV A(H5) in this three-month period involved single birds. This indicates that the investigation of events involving single dead birds of target species is important for comprehensive passive surveillance for HPAI A(H5). Moreover, 20 low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. The risk of zoonotic transmission to the general public in Europe is considered to be very low. The first human case due to avian influenza A(H7N4) was notified in China underlining the threat that newly emerging avian influenza viruses pose for transmission to humans. Close monitoring is required of the situation in Africa and the Middle East with regards to HPAI A(H5N1) and A(H5N8). Uncontrolled spread of virus and subsequent further genetic evolution in regions geographically connected to Europe may increase uncertainty and risk for further dissemination of virus. The risk of HPAI introduction from Third countries via migratory wild birds to Europe is still considered much lower for wild birds crossing the southern borders compared to birds crossing the north-eastern borders, whereas the introduction via trade is still very to extremely unlikely., (© 2018 European Food Safety Authority, © European Centre for Disease Prevention and Control, and © European Union Reference Laboratory for Avian Influenza. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Between 1 September and 15 November 2017, 48 A(H5N8) highly pathogenic avian influenza (HPAI) outbreaks in poultry holdings and 9 H5 HPAI wild bird events were reported within Europe. A second epidemic HPAI A(H5N8) wave started in Italy on the third week of July and is still ongoing on 15 November 2017. The Italian epidemiological investigations indicated that sharing of vehicles, sharing of personnel and close proximity to infected holdings are the more likely sources of secondary spread in a densely populated poultry area. Despite the ongoing human exposures to infected poultry during the outbreaks, no transmission to humans has been identified in the EU. The report includes an update of the list of wild bird target species for passive surveillance activities that is based on reported AI-infected wild birds since 2006. The purpose of this list is to provide information on which bird species to focus in order to achieve the most effective testing of dead birds for detection of H5 HPAI viruses. Monitoring the avian influenza situation in other continents revealed the same risks as in the previous report (October 2016-August 2017): the recent human case of HPAI A(H5N6) in China underlines the continuing threat of this avian influenza virus to human health and possible introduction via migratory wild birds into Europe. Close monitoring is required of the situation in Africa with regards to HPAI of the subtypes A(H5N1) and A(H5N8), given the rapidity of the evolution and the uncertainty on the geographical distribution of these viruses. Interactions between EFSA and member states have taken place to initiate discussions on improving the quality of data collections and to find a step-wise approach to exchange relevant (denominator) data without causing an additional resource burden., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

EFSA assisted four countries in the analysis of epidemiological data on African swine fever (ASF), collected until September 2017. The temporal analysis demonstrated that the average proportions of PCR and antibody-ELISA positive samples from the hunted wild boar remained below 3.9 and 6.6, respectively. A peak in the ASF incidence was observed 6 months after the first observed case, followed by a significant reduction of the number of cases and low levels of African swine fever virus (ASFV) circulation at the end of 38 months follow-up period at different spatial resolutions. The spatial analysis concluded that human-mediated spread of ASFV continues to play a critical role in the ASF epidemiology, despite all measures currently taken. 'Wild boar density', 'total road length' (as proxy for human activity) and 'average suitable wild boar habitat availability' were identified as predictors for the occurrence of ASF in Estonia by a Bayesian hierarchical model, whereas 'wild boar density' and 'density of pig farms' were predictors according to a generalised additive model. To evaluate the preventive strategies proposed in EFSA's Scientific Opinion (2015) to stop the spread of ASFV in the wild boar population, a simulation model, building on expert knowledge and literature was used. It was concluded that reduction of wild boar population and carcass removal to stop the spread of ASFV in the wild boar population are more effective when applied preventively in the infected area. Drastic depopulation, targeted hunting of female wild boar and carcass removal solely implemented as measures to control ASF in the wild boar population need to be implemented in a highly effective manner (at or beyond the limit of reported effectivity in wild boar management) to sustainably halt the spread of ASF., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The A(H5N8) highly pathogenic avian influenza (HPAI) epidemic occurred in 29 European countries in 2016/2017 and has been the largest ever recorded in the EU in terms of number of poultry outbreaks, geographical extent and number of dead wild birds. Multiple primary incursions temporally related with all major poultry sectors affected but secondary spread was most commonly associated with domestic waterfowl species. A massive effort of all the affected EU Member States (MSs) allowed a descriptive epidemiological overview of the cases in poultry, captive birds and wild birds, providing also information on measures applied at the individual MS level. Data on poultry population structure are required to facilitate data and risk factor analysis, hence to strengthen science-based advice to risk managers. It is suggested to promote common understanding and application of definitions related to control activities and their reporting across MSs. Despite a large number of human exposures to infected poultry occurred during the ongoing outbreaks, no transmission to humans has been identified. Monitoring the avian influenza (AI) situation in other continents indicated a potential risk of long-distance spread of HPAI virus (HPAIV) A(H5N6) from Asia to wintering grounds towards Western Europe, similarly to what happened with HPAIV A(H5N8) and HPAIV A(H5N1) in previous years. Furthermore, the HPAI situation in Africa with A(H5N8) and A(H5N1) is rapidly evolving. Strengthening collaborations at National, EU and Global levels would allow close monitoring of the AI situation, ultimately helping to increase preparedness. No human case was reported in the EU due to AIVs subtypes A(H5N1), A(H5N6), A(H7N9) and A(H9N2). Direct transmission of these viruses to humans has only been reported in areas, mainly in Asia and Egypt, with a substantial involvement of wild bird and/or poultry populations. It is suggested to improve the collection and reporting of exposure events of people to AI., (© 2017 European Food Safety Authority, © European Centre for Disease Prevention and Control, and © European Union Reference Laboratory for Avian influenza EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Previous introductions of highly pathogenic avian influenza virus (HPAIV) to the EU were most likely via migratory wild birds. A mathematical model has been developed which indicated that virus amplification and spread may take place when wild bird populations of sufficient size within EU become infected. Low pathogenic avian influenza virus (LPAIV) may reach similar maximum prevalence levels in wild bird populations to HPAIV but the risk of LPAIV infection of a poultry holding was estimated to be lower than that of HPAIV. Only few non-wild bird pathways were identified having a non-negligible risk of AI introduction. The transmission rate between animals within a flock is assessed to be higher for HPAIV than LPAIV. In very few cases, it could be proven that HPAI outbreaks were caused by intrinsic mutation of LPAIV to HPAIV but current knowledge does not allow a prediction as to if, and when this could occur. In gallinaceous poultry, passive surveillance through notification of suspicious clinical signs/mortality was identified as the most effective method for early detection of HPAI outbreaks. For effective surveillance in anseriform poultry, passive surveillance through notification of suspicious clinical signs/mortality needs to be accompanied by serological surveillance and/or a virological surveillance programme of birds found dead (bucket sampling). Serosurveillance is unfit for early warning of LPAI outbreaks at the individual holding level but could be effective in tracing clusters of LPAIV-infected holdings. In wild birds, passive surveillance is an appropriate method for HPAIV surveillance if the HPAIV infections are associated with mortality whereas active wild bird surveillance has a very low efficiency for detecting HPAIV. Experts estimated and emphasised the effect of implementing specific biosecurity measures on reducing the probability of AIV entering into a poultry holding. Human diligence is pivotal to select, implement and maintain specific, effective biosecurity measures., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Infestation with Varroa spp. (varroosis) 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 varroosis to be listed, Article 9 for the categorisation of varroosis according to disease prevention and control rules as in Annex IV and Article 8 on the list of animal species related to varroosis. 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 varroosis 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 criterion 5 A(v). Consequently, the assessment on compliance of varroosis with the criteria as in Annex IV to the AHL, for the application of the disease prevention and control rules referred to in Article 9(1), and which animal species can be considered to be listed for varroosis according to Article 8(3) are also inconclusive., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

MeClas is a web-based tool to generate (eco)toxicity hazard categories and corresponding classification & labelling information of inorganic metal-containing complex materials such as ores, concentrates, intermediates or alloys for which the manual application of the GHS/CLP rules is very complex and requires a high level of consistency. The tool comprises several tiers, aimed at the progressive refinement of classification through recognition of specific mineral content, speciation/mineralogy up to bio-availability corrections. Where relevant in a regional jurisdiction (EU and US), mandatory classification references are used complementary to high quality (eco)toxicity reference values (ERV/TRV) and self-classifications. MeClas addresses the GHS human health and environmental hazard endpoints, is based on an unambiguous algorithm defined under GHS/CLP, has a well defined domain of applicability and robust predictability. MeClas allows a consistent approach across companies in line with GHS ruling (and regional implementations), considering the metal specificities and related classification GHS/CLP Guidance, and the most up to date (eco)-toxicological hazard information on self-classifications and ERV/TRV., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Low pathogenic avian influenza (LPAI) 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 LPAI to be listed, Article 9 for the categorisation of LPAI according to disease prevention and control rules as in Annex IV and Article 8 on the list of animal species related to LPAI. 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 levels. 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, LPAI 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 3 and 5 of Annex IV of the AHL, for the application of the disease prevention and control rules referred to in points (c) and (e) of Article 9(1). The animal species to be listed for LPAI according to Article 8(3) criteria are all species of domestic poultry and wild species of mainly Anseriformes and Charadriiformes, as indicated in the present opinion., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Current approaches to risk assessment in bees do not take into account co-exposures from multiple stressors. The European Food Safety Authority (EFSA) is deploying resources and efforts to move towards a holistic risk assessment approach of multiple stressors in bees. This paper describes the general principles of pesticide risk assessment in bees, including recent developments at EFSA dealing with risk assessment of single and multiple pesticide residues and biological hazards. The EFSA Guidance Document on the risk assessment of plant protection products in bees highlights the need for the inclusion of an uncertainty analysis, other routes of exposures and multiple stressors such as chemical mixtures and biological agents. The EFSA risk assessment on the survival, spread and establishment of the small hive beetle, Aethina tumida, an invasive alien species, is provided with potential insights for other bee pests such as the Asian hornet, Vespa velutina. Furthermore, data gaps are identified at each step of the risk assessment, and recommendations are made for future research that could be supported under the framework of Horizon 2020. Finally, the recent work conducted at EFSA is presented, under the overarching MUST-B project ("EU efforts towards the development of a holistic approach for the risk assessment on MUltiple STressors in Bees") comprising a toolbox for harmonised data collection under field conditions and a mechanistic model to assess effects from pesticides and other stressors such as biological agents and beekeeping management practices, at the colony level and in a spatially complex landscape. Future perspectives at EFSA include the development of a data model to collate high quality data to calibrate and validate the model to be used as a regulatory tool. Finally, the evidence collected within the framework of MUST-B will support EFSA's activities on the development of a holistic approach to the risk assessment of multiple stressors in bees. In conclusion, EFSA calls for collaborative action at the EU level to establish a common and open access database to serve multiple purposes and different stakeholders., (Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.)

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., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

MERLIN-Expo is a library of models that was developed in the frame of the FP7 EU project 4FUN in order to provide an integrated assessment tool for state-of-the-art exposure assessment for environment, biota and humans, allowing the detection of scientific uncertainties at each step of the exposure process. This paper describes the main features of the MERLIN-Expo tool. The main challenges in exposure modelling that MERLIN-Expo has tackled are: (i) the integration of multimedia (MM) models simulating the fate of chemicals in environmental media, and of physiologically based pharmacokinetic (PBPK) models simulating the fate of chemicals in human body. MERLIN-Expo thus allows the determination of internal effective chemical concentrations; (ii) the incorporation of a set of functionalities for uncertainty/sensitivity analysis, from screening to variance-based approaches. The availability of such tools for uncertainty and sensitivity analysis aimed to facilitate the incorporation of such issues in future decision making; (iii) the integration of human and wildlife biota targets with common fate modelling in the environment. MERLIN-Expo is composed of a library of fate models dedicated to non biological receptor media (surface waters, soils, outdoor air), biological media of concern for humans (several cultivated crops, mammals, milk, fish), as well as wildlife biota (primary producers in rivers, invertebrates, fish) and humans. These models can be linked together to create flexible scenarios relevant for both human and wildlife biota exposure. Standardized documentation for each model and training material were prepared to support an accurate use of the tool by end-users. One of the objectives of the 4FUN project was also to increase the confidence in the applicability of the MERLIN-Expo tool through targeted realistic case studies. In particular, we aimed at demonstrating the feasibility of building complex realistic exposure scenarios and the accuracy of the modelling predictions through a comparison with actual measurements., (Copyright © 2016 Elsevier B.V. All rights reserved.)

An important step in building a computational model is its documentation; a comprehensive and structured documentation can improve the model applicability and transparency in science/research and for regulatory purposes. This is particularly crucial and challenging for environmental and/or human exposure models that aim to establish quantitative relationships between personal exposure levels and their determinants. Exposure models simulate the transport and fate of a contaminant from the source to the receptor and may involve a large set of entities (e.g. all the media the contaminants may pass though). Such complex models are difficult to be described in a comprehensive, unambiguous and accessible way. Bad communication of assumptions, theory, structure and/or parameterization can lead to lack of confidence by the user and it may be source of errors. The goal of this paper is to propose a standard documentation protocol (SDP) for exposure models, i.e. a generic format and a standard structure by which all exposure models could be documented. For this purpose, a CEN (European Committee for Standardisation) workshop was set up with objective to agree on minimum requirements for the amount and type of information to be provided on exposure models documentation along with guidelines for the structure and presentation of the information. The resulting CEN workshop agreement (CWA) was expected to facilitate a more rigorous formulation of exposure models description and the understanding by users. This paper intends to describe the process followed for defining the SDP, the standardisation approach, as well as the main components of the SDP resulting from a wide consultation of interested stakeholders. The main outcome is a CEN CWA which establishes terms and definitions for exposure models and their elements, specifies minimum requirements for the amount and type of information to be documented, and proposes a structure for communicating the documentation to different users., (Copyright © 2016 Elsevier B.V. All rights reserved.)

The European Union (EU) chemicals regulation Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) requires a hazardous substance registration to identify the uses of a substance and the corresponding conditions of safe use. This requirement includes a human and an environmental safety assessment. Exposure scenarios are developed and employed for estimating emissions resulting from the uses of hazardous substances. To support the environmental assessments, the REACH guidance documents define 22 environmental release categories (ERCs) with conservative release factors (RFs) to water, air, and soil. Several industry associations target the ERCs to more specific uses and respective emission scenarios to enable more realistic emission estimations. They have developed more than 190 specific ERCs (SPERCs) as standardized descriptions of operational conditions (OCs) and risk management measures (RMMs). SPERCs reflect the current good practice and are documented in factsheets. These factsheets contain the information necessary for environmental emission modeling. Key parameters are the substance use rate, the efficiency of the risk management measures (if applicable), and the RFs. These parameters can be based on literature or measured company data or are justified by qualitative arguments. The majority of SPERCs have been implemented as realistic worst-case emission values in screening-level chemical safety assessment (CSA) tools. Three regulatory reviews in Europe have established requirements for documenting the SPERCs and for justifying the RFs. In addition, each of the reviews included recommendations for improving the SPERCs. The latest review proposed a condensed factsheet that focuses on the essentials for exposure assessment and subsequent communication in safety data sheets. It is complemented with a background document for providing details on the emission scenarios and justifications. In the EU the SPERCs will be further progressed in a consensus process using the multi-stakeholder expert network on exposure scenarios. The SPERCs have the potential to be used in environmental risk assessments within other regulatory frameworks or in other geographical regions. Integr Environ Assess Manag 2016;12:772-781. © 2015 SETAC., (© 2015 SETAC.)

MERLIN-Expo merges and integrates advanced exposure assessment methodologies, allowing the building of complex scenarios involving several pollution sources and targets. The assessment of exposure and risks to human health from chemicals is of major concern for policy and ultimately benefits all citizens. The development and operational fusion of the advanced exposure assessment methodologies envisaged in the MERLIN-Expo tool will have a significant impact in the long term on several policies dealing with chemical safety management. There are more than 30 agencies in Europe related to exposure and risk evaluation of chemicals, which have an important role in implementing EU policies, having especially tasks of technical, scientific, operational and/or regulatory nature. The main purpose of the present paper is to introduce MERLIN-Expo and to highlight its potential for being effectively integrated within the group of tools available to assess the risk and exposure of chemicals for EU policy. The main results show that the tool is highly suitable for use in site-specific or local impact assessment, with minor modifications it can also be used for Plant Protection Products (PPPs), biocides and REACH, while major additions would be required for a comprehensive application in the field of consumer and worker exposure assessment., (Copyright © 2016. Published by Elsevier B.V.)

Background: Preeclampsia is frequent in Kinshasa (Democratic Republic of Congo), especially during the dry season. We tested whether preeclampsia was associated with exposure to environmental metals., Methods: Using a case-control design, 88 women hospitalized with preeclampsia (cases) and 88 healthy pregnant women from the antenatal clinic (controls) were included in the study; 67 and 109 women were enrolled during the rainy and dry season, respectively. The concentrations of 24 elements were quantified by inductively coupled plasma mass spectrometry (ICP-MS) in 24-h urine collections. Differences in the urinary excretion of metals were investigated between cases and controls, and the interaction with season was assessed., Results: Cases and controls were well matched regarding age, parity and duration of pregnancy. In controls, the urinary concentrations of most elements were substantially higher than reference values for adults from industrially developed countries, e.g. for lead: geometric mean (GM) 8.0 μg/L [25(th)-75(th) percentile 3.1-13.8]. The daily urinary excretions of 14 metals were significantly higher in women with preeclampsia than in control women, e.g. for lead: GM 61 μg/day (25(th)-75(th) percentile 8-345) in women with preeclampsia vs 9 μg/day (25(th)-75(th) percentile 3-21) in controls (p < 0.001). A significant interaction was found between season and preeclampsia for several elements, with higher urinary excretions in preeclamptic women than controls during the dry season, but not during the rainy season., Conclusions: This study revealed not only that women with preeclampsia excrete higher amounts of several toxic metals, especially lead, than control women, but also that this excretion exhibits seasonal variation, thus possibly explaining the high incidence and seasonal variation of preeclampsia in Kinshasa. Although the exact sources of this exposure are unknown, these findings underscore the need for preventing environmental exposures to lead and other toxic metals.

Little is known about the magnitude of the effects of lead shot ingestion alone or combined with poisons (e.g., in bait or seeds/granules containing pesticides) on population size, growth, and extinction of non-waterbird avian species that ingest these substances. We used population models to create example scenarios demonstrating how changes in these parameters might affect three susceptible species: grey partridge (Perdix perdix), common buzzard (Buteo buteo), and red kite (Milvus milvus). We added or subtracted estimates of mortality due to lead shot ingestion (4-16% of mortality, depending on species) and poisons (4-46% of mortality) reported in the UK or France to observed mortality of studied populations after models were calibrated to observed population trends. Observed trends were decreasing for partridge (in continental Europe), stable for buzzard (in Germany), and increasing for red kite (in Wales). Although lead shot ingestion and poison at modeled levels did not change the trend direction for the three species, they reduced population size and slowed population growth. Lead shot ingestion at modeled rates reduced population size of partridges by 10%, and when combined with bait and pesticide poisons, by 18%. For buzzards, decrease in mean population size by lead shot and poisons combined was much smaller (≤ 1%). The red kite population has been recovering; however, modeled lead shot ingestion reduced its annual growth rate from 6.5% to 4%, slowing recovery. If mortality from poisoned baits could be removed, the kite population could potentially increase at a rapid annual rate of 12%. The effects are somewhat higher if ingestion of these substances additionally causes sublethal reproductive impairment. These results have uncertainty but suggest that declining or recovering populations are most sensitive to lead shot or poison ingestion, and removal of poisoned baits can have a positive impact on recovering raptor populations that frequently feed on carrion.

Since the beginning of November 2014, nine outbreaks of highly pathogenic avian influenza virus (HPAIV) A(H5N8) in poultry have been detected in four European countries. In this report, similarities and differences between the modes of introduction of HPAIV A(H5N1) and A(H5N8) into Europe are described. Experiences from outbreaks of A(H5N1) in Europe demonstrated that early detection to control HPAIV in poultry has proven pivotal to minimise the risk of zoonotic transmission and prevention of human cases.

Background: Breast cancer incidence in African population is low compared to western countries but the mortality rate is higher and the disease presents at a younger age and at a more advanced stage. The World Health Organisation and the Breast Health Global Initiative concluded that in low and middle income countries early breast cancer detection can be achieved by informing women on symptoms of breast cancer, on the practice of breast self-examination and clinical breast examination by trained health care workers. Based on these recommendations, we set up a breast cancer awareness campaign in Kinshasa, Democratic Republic of Congo (DRC). This paper describes the strategy that was established and the results that were achieved., Methods: A breast cancer awareness campaign was started in 2010 and data were collected until the end of 2012. Clinicians (expert group) trained nurses and health care workers (awareness groups) on clinical, technical and social aspects of breast cancer. Different channels were used to inform women about the campaign and clinical data (on medical and family history) were collected. The participating women were investigated with clinical breast examination by the awareness group. Women in whom a palpable mass was detected were referred to the hospital: they received a mammography and ultrasound and--in case of suspicious findings--additionally a core needle biopsy. In case of a positive family history, a blood sample was taken for genetic investigation., Results: In total, 4,315 women participated, resulting in 1,113 radiological breast examinations, performed in the General Hospital of Kinshasa of which 101 turned out to be malignant lesions. Fifty six percent of the women with breast cancer were less than 50 years old and 75% (65/87) were stage III tumors. A BRCA gene mutation was identified in a family with a severe history of breast cancer., Conclusions: Even without financial support, it was possible to start an awareness campaign for breast cancer in Kinshasa. This campaign increased the awareness on cancer of the women in Kinshasa. The results demonstrate that this campaign had an immediate impact on patients and their families.

Vertebrate testing under the European Union's regulation on Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) is discouraged, and the use of alternative nontesting approaches such as quantitative structure-activity relationships (QSARs) is encouraged. However, robust QSARs predicting chronic ecotoxicity of organic compounds to fish are not available. The Ecological Structure Activity Relationships (ECOSAR) Class Program is a computerized predictive system that estimates the acute and chronic toxicity of organic compounds for several chemical classes based on their log octanol-water partition coefficient (K(OW)). For those chemical classes for which chronic training data sets are lacking, acute to chronic ratios are used to predict chronic toxicity to aquatic organisms. Although ECOSAR reaches a high score against the Organisation for Economic Co-operation and Development (OECD) principles for QSAR validation, the chronic QSARs in ECOSAR are not fully compliant with OECD criteria in the framework of REACH or CLP (classification, labeling, and packaging) regulation. The objective of the present study was to develop a chronic ecotoxicity QSAR for fish for compounds acting via nonpolar and polar narcosis. These QSARs were built using a database of quality screened toxicity values, considering only chronic exposure durations and relevant end points. After statistical multivariate diagnostic analysis, literature-based, mechanistically relevant descriptors were selected to develop a multivariate regression model. Finally, these QSARs were tested for their acceptance for regulatory purposes and were found to be compliant with the OECD principles for the validation of a QSAR., (© 2013 SETAC.)

The environmental risks of 33 micropollutants occurring in Belgian coastal zone were assessed as single-substances and as mixtures. Water and sediment samples were taken in harbors, coastal waters and the Scheldt estuary during 2007-2009. Measured environmental concentrations were compared to quality standards such as Predicted No Effect Concentrations (PNECs), Environmental Quality Standards (EQSs), and Ecotoxicological Assessment Criteria (EAC). Out of a total of 2547 samples analyzed, 232 and 126 samples exceeded the EQS and EAC, respectively. Highest risks were observed for TBT, PBDEs, PCBs and the PAHs anthracene, indeno(1,2,3-cd)pyrene, benzo(g,h,i)perylene, benzo(k)fluoranthene, and benzo(b)fluoranthene in the water compartment and for TBT and PCBs in the sediment compartment. Samples taken at all stations during the April 2008 campaign indicate a potential risk of the contaminant mixtures to the aquatic environment (except W06 station). This study argues the need to revise quality standards when appropriate and hence the overall regulatory implication of these standards., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

The Water Framework Directive (WFD) has the objective of a catchment-oriented water quality protection for all European waters with the purpose of achieving a good ecological and chemical quality status by the year 2015. To that end, necessary measures should be identified and implemented, with the aim of progressively reducing pollution from priority substances. The objective of this paper is to demonstrate how a dynamic model of the integrated urban wastewater system (IUWS) can be used to test different emission reduction strategies for organic priority pollutants (PPs) in a semi-hypothetical case study on di(2-ethylhexyl)phthalate (DEHP). The IUWS is composed of coupled entities: sources, urban catchment surface (run-off/infiltration), sewer system, stormwater treatment unit, wastewater treatment plant (WWTP) including sludge handling, and receiving surface water (river). State-of-the-art dynamic fate models were selected from literature and extended with an organic pollutant fate sub-model. Dynamic DEHP release profiles were estimated using a dynamic model input generator and fed to the model to predict the fate and concentration of DEHP in each IUWS sub-system. The model was then used to test eight scenarios on environmental performance, namely (1) reduction of impervious urban area, (2) reduction of infiltration in the sewer system, (3) input reduction (excluding the main pollutant sources), (4) separating the combined sewer system, (5) treatment of stormwater by stormwater infiltration ponds (separate sewer systems), (6) placement of retention basins at main sewer junctions, (7) sand filtration of secondary effluent, and (8) pre-precipitation of phosphorous. The simulation results revealed that the most effective measure in terms of river water quality improvement for DEHP (annual average and spikiness reduction) and PP concentration in the disposed WWTP sludge, is reducing release of this substance into the environment, not surprisingly. In general, this will heavily depend on the parameterisation of the scenarios., (Copyright © 2012 Elsevier B.V. All rights reserved.)

Objectives: The present study aims at determining the influence of the seasons on the occurrence of pre-eclampsia in the county city of Kinshasa (DR Congo)., Patients and Method: A multicentric descriptive study was carried out in three great maternity hospitals of this city between 2003 and 2007. The registers and files of the maternity wards and the units of intensive care were used for the gathering of medical data. The geographical data on the seasonal changes were provided by two great weather stations, which receive the satellite data on the town suit. These data include the temperature, the percentage of humidity and the rate of precipitation. This information allowed to define for each year the dry season and the season of rains., Results: Overall, 17,592 pregnant women were studied. Among these, we could find 1492 (8.5 %) cases of pre-eclampsia and 319 (1.8 %) cases of eclampsia. The distribution of these pregnant women according to two seasons revealed that 11,358 (64 %) pregnancies were seen during the season of rain and that among these, 681 (6 %) were complicated by pre-eclampsia. During the dry season, 6234 (36 %) pregnancies occurred and among these we found 811 (13 %) cases of pre-eclampsia., Discussion and Conclusion: The seasonal distribution reveals that the incidence of pre-eclampsia is significantly higher during the dry season than during the rainy season, but probably is not directly related to meteorological factors but rather on the nutritional deficiencies caused by the low rate of precipitations., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

Sialoadhesin is exclusively expressed on specific subpopulations of macrophages. Since sialoadhesin-positive macrophages are involved in inflammatory autoimmune diseases, such as multiple sclerosis, and potentially in the generation of immune responses, targeted delivery of drugs, toxins or antigens via sialoadhesin-specific immunoconjugates may prove a useful therapeutic strategy. Originally, sialoadhesin was characterized as a lymphocyte adhesion molecule, though recently its involvement in internalization of sialic acid carrying pathogens was shown, suggesting that sialoadhesin is an endocytic receptor. In this report, we show that porcine sialoadhesin-specific antibodies and F(ab')₂ fragments trigger sialoadhesin internalization, both in primary porcine macrophages and in cells expressing recombinant porcine sialoadhesin. Using chemical inhibitors, double immunofluorescence stainings and dominant-negative constructs, porcine sialoadhesin internalization was shown to be clathrin- and Eps15-dependent and to result in targeting to early endosomes but not lysosomes. Besides characterizing the sialoadhesin endocytosis mechanism, two sialoadhesin-specific immunoconjugates were evaluated. We observed that porcine sialoadhesin-specific immunotoxins efficiently kill sialoadhesin-expressing macrophages. Furthermore, porcine sialoadhesin-specific albumin immunoconjugates were shown to be internalized in macrophages and immunization with these immunoconjugates resulted in a rapid and robust induction of albumin-specific antibodies, this compared to immunization with albumin alone. Together, these data expand sialoadhesin functionality and show that it can function as an endocytic receptor, a feature that cannot only be misused by sialic acid carrying pathogens, but that may also be used for specific targeting of toxins or antigens to sialoadhesin-expressing macrophages.

Escherichia coli (E. coli) O157:H7 can cause haemorrhagic colitis and the haemolytic uremic syndrome in humans. Ruminants are the main reservoir for this bacterium: they can harbour the bacteria in the gastrointestinal tract without showing clinical symptoms. The reason for this persistence is still unclear, although it has been suggested that E. coli O157:H7 can suppress the immune system. To investigate the effects on the immune system of ruminants, an infection model is needed that mimics a long-term infection as it can occur in both sheep and cattle. As the terminal rectum has recently been identified as a primary colonisation site in cattle, we developed a rectal inoculation model for sheep and used this model to study immune responses against selected virulence factors of E. coli O157:H7 (intimin, EspA and EspB). Sheep were infected and re-infected when E. coli O157:H7 excretion was no longer detectable. The animals did not develop serum or local antibody responses but showed a cellular response against EspA and intimin respectively 9 and 16 days after infection. This response was also present 5 days after re-infection, albeit lower, and did not prevent animals from being re-infected. These results demonstrate that E. coli O157:H7 can be persistently present in the large intestine of sheep without inducing a clear protective immune response., (Copyright © 2010 Elsevier B.V. All rights reserved.)

Infections with F4(+) enterotoxigenic Escherichia coli (ETEC) causes severe diarrhoea in piglets, resulting in morbidity and mortality. F4 fimbriae are the key virulence factors mediating the attachment of F4(+) ETEC to the intestinal epithelium. Intestinal epithelial cells (IEC) are recently being recognized as important regulators of the intestinal immune system through the secretion of cytokines, however, data on how F4(+) ETEC affect this cytokine secretion are scarce. By using ETEC strains expressing either polymeric, monomeric or F4 fimbriae with a reduced polymeric stability, we demonstrated that polymeric fimbriae are essential for adhesion to porcine IEC and the secretion of IL-6 and IL-8 by IEC. Remarkably, this cytokine secretion was not abrogated following stimulation with an F4-negative strain. Since this strain expresses flagellin, TLR5 mediated signalling could be involved. Indeed, porcine IEC express TLR5 and purified flagellin induced IL-6 and IL-8 secretion, indicating that, as for other pathogens, flagellin is the dominant virulence factor involved in the induction of proinflammatory responses in IEC. These results indicate a potential mucosal adjuvant capacity of ETEC-derived flagellin and may improve rational vaccine design against F4(+) ETEC infections., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

F4(+) enterotoxigenic Escherichia coli (ETEC) infections are an important cause of postweaning diarrhoea in piglets and an oral immunization of piglets with purified F4 fimbriae protects them from a subsequent F4(+) ETEC infection. However, oral immunization of suckling piglets is hampered due to the immature status of their immune system. Targeting of antigens to Fcgamma receptors (FcgammaR) on human and murine dendritic cells (DC) has been shown to enhance DC maturation and both humoral and cellular immune responses. To investigate the effect of F4 fimbriae incorporated in immune complexes (F4-IC) on porcine DC, we used porcine monocytic-derived DC (MoDC) as a model system. The results in this study demonstrate that FcgammaRI, II and III mRNA is expressed by porcine MoDC. Furthermore, we show that FcgammaRII and III are expressed on the cell surface and that F4-IC are internalized by MoDC via FcgammaR. This FcgammaR ligation induced a significantly enhanced expression of Major Histocompatibility complex (MHCII) class II and the costimulatory molecules CD80/86 and CD40 by MoDC compared with immature MoDC. Furthermore, the phagocytic capacity of F4-IC stimulated MoDC was reduced as evidenced by a reduced uptake of DQ-ovalbumin and FITC-dextran. In an allogenic and autologous mixed lymphocyte reaction, these F4-IC-activated MoDC showed an improved T cell stimulatory capacity in comparison with immature MoDC. The F4-IC induced DC maturation correlated with significant higher expression levels of several pro-inflammatory cytokines such as interleukine (IL) 1beta, IL-6 and Tumor necrosis factor alpha, the chemokine IL-8 and IL-12p40 in comparison with immature MoDC. Altogether, these results clearly demonstrate that FcgammaR engagement enhances the maturation of porcine MoDC, which may suggest that antigen targeting to FcgammaR on DC could improve vaccine design against infections., (Copyright 2009 Elsevier B.V. All rights reserved.)

Antigen-presenting cells (APCs) in the small intestinal mucosa perform dual functions of maintaining tissue homeostasis and of protecting against intestinal pathogens as key inducers of both innate and adaptive immune responses. Intestinal APCs are thus important regulators of intestinal immunity and also potential target cells for mucosal adjuvants such as cholera toxin (Ctx), which was used successfully in several oral vaccination studies in pigs. The aims of the present study were (1) to isolate porcine small intestinal APCs and evaluate the feasibility of using these cells for functional in vitro studies and (2) to determine the response of intestinal APCs to Ctx. Microscopic and flow cytometric analyses using antibodies to CD1, CD11R1, CD16, and SIRPalpha (SWC3) revealed the presence of multiple subsets of MHC-II(++) APCs in porcine small intestinal mucosa. The alpha-integrin subunit CD11R1 was most frequently expressed and therefore chosen as a selection marker. CD11R1(+) cells were enriched from total lamina propria cells to >90% purity by immunomagnetic separation. Within the CD11R1 cells, we identified two populations with distinct forward and side scatter characteristics: (1) APCs identified by their high expression of MHC-II and consisting of SIRPalpha(+) and SIRPalpha(-) subsets, and (2) contaminating eosinophils. In culture, intestinal APCs spontaneously matured, as shown by significant (>5-fold) increase in CD80/CD86 expression. The SIRPalpha(+) APCs quickly disappeared from the cultures, likely due to increased apoptotic cell death. However, the observed spontaneous changes in the isolated cell population did not mask the effects of stimulation with Ctx, which resulted in a 2.5-fold increase in the expression of maturation markers CD80/CD86, but significant loss of T cell stimulatory function, corroborating previous results obtained with MoDC., (Copyright 2009 Elsevier B.V. All rights reserved.)

The effect of oral administration of beta-1,3/1,6-glucans from Saccharomyces cerevisiae on humoral immunity in domestic dogs is not known. In this study, 15 beagle dogs were orally given MacroGard tablets, which contain 150 mg of this beta-glucan, daily for 4 weeks. At the end of this period, the total serum immunoglobulin A (IgA) level decreased significantly in the group treated with the glucan compared to that in the control group as well as compared to the concentrations before supplementation. In contrast, the total serum IgM level rose significantly, whereas no effect on the IgG level occurred. Similar changes were seen in Bordetella-specific IgA and IgM titers following vaccination during the supplementation period. The IgA concentration also became significantly lower in the saliva and tears of the glucan group than in the placebo group. The effects disappeared 1 week after the cessation of the supplementation. In conclusion, the results showed a temporary change in the isotype profile during glucan supplementation.

Parabutoporin (PP) from the South African scorpion Parabuthus schlechteri is a 45-mer lysine-rich and cysteine-free peptide. At micromolar concentrations it has antimicrobial effects against G+ and G- bacteria and is antifungal as well. However, at submicromolar concentrations, parabutoporin also directly interferes with cellular functions of the human innate immune system, especially polymorphonuclear neutrophils (PMN): parabutoporin acts as a chemoattractant for neutrophils, induces their degranulation, while delaying constitutive neutrophil apoptosis. In addition, it potently inhibits induced superoxide production. Different signalling pathways regulating these biochemical processes were identified as targets of parabutoporin. Therefore, parabutoporin is a well documented scorpion venom peptide with immuno-regulatory properties beyond its antibiotic effects., (Copyright 2009 Elsevier Ltd. All rights reserved.)

Integrated urban water system (IUWS) modeling aims at assessing the quality of the surface water receiving the urban emissions through sewage treatment plants, combined sewer overflows (CSOs) and stormwater drainage systems. However, some micropollutants tend to appear in more than one environmental medium (air, water, sediment, soil, groundwater, etc.). In this work, a multimedia fate and transport model (MFTM) is "wrapped around" a dynamic IUWS model for organic micropollutants to enable integrated environmental assessment. The combined model was tested on a hypothetical catchment using two scenarios: on the one hand a reference scenario with a combined sewerage system and on the other hand a stormwater infiltration pond scenario, as an example of a sustainable urban drainage system (SUDS). A case for Bis(2-ethylhexyl) phthalate (DEHP) was simulated and resulted in reduced surface water concentrations for the latter scenario. However, the model also showed that this was at the expense of increased fluxes to air, groundwater and infiltration pond soil. The latter effects are generally not included in IUWS models, whereas MTFMs usually do not consider dynamic surface water concentrations,; hence the combined model approach provides a better basis for integrated environmental assessment of micropollutants' fate in urban environments.

A risk assessment report (RAR) on zinc and zinc compounds has recently been prepared in the framework of the European Union (EU) Council Regulation 793/93/EEC on Existing Chemicals. The EU Scientific Committee on Human and Environmental Risks (SCHER) has, however, expressed some fundamental, science-based concerns about the approach followed and the conclusions. The main objective of the present study was to assess the potential environmental risks associated with current use patterns of Zn in nine EU river basins in Germany, France and Belgium, thereby using more advanced methodologies which are largely in line with the recommendations made by SCHER. This included (i) avoiding working with measured Zn concentrations from monitoring stations that were potentially influenced by point sources and/or historical contamination, (ii) the full bioavailability normalization of all chronic ecotoxicity data to river basin specific physico-chemistry using biotic ligand models (BLM), prior to deriving predicted no effect concentrations (PNEC) with the species sensitivity distribution (SSD) approach, and (iii) the use of a probabilistic framework for risk characterization. Further, a total risk approach instead of an added risk approach was used, and the PNEC was equated to the HC5-50 without an additional assessment factor. Based on monitoring data we estimated predicted environmental concentrations (PEC) for the different EU river basins between 1.3 and 14.6 microg dissolved Zn/L. PNEC values varied between 22.1 and 46.1 microg dissolved Zn/L. This resulted in deterministic risk characterization ratios (RCR) that were below 1 in all river basins, suggesting that there is no deterministic regional risk associated with current use patterns of Zn in these river basins. With the probabilistic approach we identified rather limited risks, i.e., between <0.4 and 18.3%. When the EU RAR approach was applied to the same monitoring datasets, deterministic risks were found in different river basins. A detailed analysis showed that this different deterministic conclusion of risk is mainly due to the fact that the EU RAR (i) uses an additional assessment factor of 2 to derive the PNEC and (ii) uses a more conservative approach for implementing bioavailability (BioF approach). We argue that the larger conservatism in the EU RAR mainly originates from decisions made to deal in a pragmatic way with (i) uncertainty related to the across-species extrapolation of BLMs and (ii) the relatively high sensitivity of some multi-species toxicity studies.

Consumption of food or feed contaminated with fumonisin B(1) (FB(1)), a mycotoxin produced by Fusarium verticillioides, can lead to disease in humans and animals. The present study was conducted to examine the effect of FB1 intake on the intestinal immune system. Piglets were used as a target and as a model species for humans since their gastro-intestinal tract is very similar. The animals were orally exposed to a low dose of FB(1) (1 mg/kg body weight FB(1)) for 10 days which did not result in clinical signs. However, when compared to non-exposed animals, FB(1)-exposed animals showed a longer shedding of F4(+) enterotoxigenic Escherichia coli (ETEC) following infection and a lower induction of the antigen-specific immune response following oral immunization. Further analyses to elucidate the mechanisms behind these observations revealed a reduced intestinal expression of IL-12p40, an impaired function of intestinal antigen presenting cells (APC), with decreased upregulation of Major Histocompatibility Complex Class II molecule (MHC-II) and reduced T cell stimulatory capacity upon stimulation. Taken together, these results indicate an FB(1)-mediated reduction of in vivo APC maturation.

The European Water Framework Directive (WFD) aims at achieving a good ecological and chemical status of surface waters in river basins by 2015. The chemical status is considered good if the Environmental Quality Standards (EQSs) are met for all substances listed on the priority list and eight additional specific emerging substances. To check compliance with these standards, the WFD requires the establishment of monitoring programmes. The minimum measuring frequency for priority substances is currently set at once per month. This can result in non-representative sampling and increased probability of misinterpretation of the surface water quality status. To assist in the classification of the water body, the combined use of monitoring data and pollutant fate models is recommended. More specifically, dynamic models are suggested, as possible exceedance of the quality standards can be predicted by such models. In the presented work, four realistic scenarios are designed and discussed to illustrate the usefulness of dynamic pollutant fate models for implementing the WFD. They comprise a combination of two priority substances and two rivers, representative for Western Europe.

Objectives: Dietary intake of long-chain (LC) n-3 PUFA in developed countries is low compared with recommendations. Fish is naturally rich in LC n-3 PUFA, but is also a dietary source of heavy metals and organic pollutants. We investigated whether the recommendation for LC n-3 PUFA could be reached through fish consumption, without exceeding the provisional tolerable weekly intake of methylmercury (MeHg) and the tolerable weekly intake (TWI) of dioxin-like compounds. Also, the contribution of margarines enriched with LC n-3 PUFA was assessed., Design: Published nutrient and contaminant data were used in a probabilistic model to calculate the simultaneous nutrient and contaminant intake for different fish consumption scenarios., Results: The Belgian recommendation for EPA + DHA (0.3% of total energy intake) can be reached by consuming fatty fish a minimum of twice a week, or by varying between lean and fatty fish a minimum of three times a week. At this fish consumption level, MeHg intake is not an issue of toxicological concern. The intake of dioxin-like compounds approximates the TWI when consuming fatty fish more than twice a week, this being a potential toxicological risk because other food items also contribute to the weekly intake of dioxin-like compounds. Use of margarine enriched with LC n-3 PUFA can help to increase LC n-3 intake, on average by 159 mg/d., Conclusions: Combination of regular fish consumption (twice a week) with important contribution of fatty fish species, in combination with regular consumption of margarine enriched with EPA + DHA, can be advised to achieve the recommendation for LC n-3 intake.