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The BfR MEAL Study aims to provide representative levels of chemical substances in foods consumed by the population in Germany for dietary exposure assessment. Calcium, potassium and phosphorus (Ca, K, P) are essential to obtain physiological functions in humans. Levels were investigated in 356 foods. Foods were purchased representatively, prepared as typically consumed and pooled before analysis. High mean levels were found in milk, dairy products, legumes, nuts, oilseeds and spices as well as chia seeds (Ca, K, P), chewing gum (Ca) and cocoa powder (K). Different levels comparing organically and conventionally produced foods were determined among others in cereal cracker (puffed), olives and tofu. Higher K levels were found in fried compared to boiled potatoes. Similar P levels were mainly found in regionally and seasonally sampled foods. These data provide a substantially improved basis to address dietary exposure assessment of the population in Germany for Ca, K and P.

Quantitative risk assessments for Bovine spongiform encephalopathy (BSE) necessitate estimates for key parameters such as the prevalence of infection, the probability of absence of infection in defined birth cohorts, and the numbers of BSE-infected, but non-detected cattle entering the food chain. We estimated three key parameters with adjustment for misclassification using the German BSE surveillance data using a Gompertz model for latent (i.e., unobserved) age-dependent detection probabilities and a Poisson response model for the number of BSE cases for birth cohorts 1999 to 2015. The models were combined in a Bayesian framework. We estimated the median true BSE prevalence between 3.74 and 0.216 cases per 100,000 animals for the birth cohorts 1990 to 2001 and observed a peak for the 1996 birth cohort with a point estimate of 16.41 cases per 100,000 cattle. For birth cohorts ranging from 2002 to 2013, the estimated median prevalence was below one case per 100,000 heads. The calculated confidence in freedom from disease (design prevalence 1 in 100,000) was above 99.5% for the birth cohorts 2002 to 2006. In conclusion, BSE surveillance in the healthy slaughtered cattle chain was extremely sensitive at the time, when BSE repeatedly occurred in Germany (2000–2009), because the entry of BSE-infected cattle into the food chain could virtually be prevented by the extensive surveillance program during these years and until 2015 (estimated non-detected cases/100.000 [95% credible interval] in 2000, 2009, and 2015 are 0.64 [0.5,0.8], 0.05 [0.01,0.14], and 0.19 [0.05,0.61], respectively).

Aufgrund der dezentralen und uneinheitlichen Dokumentation der Vergiftungsfalle in Deutschland besteht im Vergleich zu anderen Landern (USA, Schweiz, Schweden, Niederlande usw.) eine wesentliche nationale Datenlucke, insbesondere in Hinblick auf die Risikofruherkennung und Risikobewertung im Bundesinstitut fur Risikobewertung (BfR). In Deutschland existieren viele Datenquellen, die Auskunft zu Vergiftungsfallen geben. Deren Erfassung basiert jedoch auf verschiedenen Grundlagen und zeigt ein zugleich breites, redundantes und luckenhaftes Spektrum auf. Die Errichtung eines nationalen Monitorings von Vergiftungen in Deutschland ist erklartes Ziel und ein notwendiger Schritt aus Sicht des BfR und der deutschen Giftinformationszentren (GIZ). Durch einen schnelleren und effizienteren technischen Zugang zu akkumulierten Daten zum nationalen Vergiftungsgeschehen ware ein umfangliches Bild zur Situation in Deutschland verfugbar. Daruber hinaus konnte eine zeitnahe Erfassung der Vergiftungsfalle ein schnelles Erkennen und Bestatigen von akuten und bisher nicht erkannten Vergiftungsgefahren ermoglichen. Relevant sind hierbei auch die Sicherheit von Produkten und der damit verbundene Schutz, insbesondere von Kindern, vor Vergiftungsunfallen. Die fortlaufende Uberwachung und Berichterstattung mit einem solchen System erfordern eine erhebliche Arbeitsanstrengung, zusatzlichen Arbeitsaufwand, eine geeignete personelle und IT-Infrastruktur und ein jahrliches Budget, welches zukunftig in der Finanzplanung des Bundes berucksichtigt werden muss.

Global sourcing of food may lead to variability in concentrations of contaminants or pesticide residues. It would be important to incorporate origin influences in dietary exposure assessment. To characterise uncertainties, substance concentrations from GFM (German Food Monitoring), chosen based on the highest CV (coefficient of variation), and food consumption from NVS II (German National Nutrition Survey II) were combined in standard scenarios. Averages or higher percentiles of non-grouped concentrations were used. Additional origin-related scenarios used concentrations grouped by origin. For bromide in tomatoes the most conservative origin-related scenario for Italian tomatoes resulted in the highest exposure of 0.015 mg/d/kg BW. The impact of origin was not covered by the conservative standard scenario (0.006 mg/d/kg BW). For ethephon in pineapples and aluminium in kiwifruits, the highest intake estimates were obtained with the conservative standard scenario resulting in 0.895 μg/d/kg BW and 0.023 mg/week/kg BW, respectively. In these two cases, standard scenarios cover origin influences but the conservative origin-related scenario based on origins with higher concentrations identifies lower exposures of 0.835 μg/d/kg BW for ethephon from African pineapples and 0.014 mg/week/kg BW for aluminium from non-EU kiwifruits. Hence, the inclusion of origin information can refine exposure assessment.

Game meat may contain elevated concentrations of lead especially if lead-containing ammunition is used for hunting. Then a health risk is possible for consumer groups with high game meat intake. The lead concentrations in three edible parts (marketable meat from the area close to the wound channel, saddle and haunch) of meat from red deer (Cervus elaphus) between animals hunted either with lead or non‑lead ammunition were compared. Furthermore, lead levels in game meat of lead-shot red deer were compared with those of lead-shot roe deer and lead-shot wild boar. Ninety red deer were shot and killed in the context of this study (64 with lead and 26 with non‑lead ammunition). Since the lead concentration for a number of the samples was below the limit of detection or the limit of quantification, statistical methods for left-censored data were applied. The median concentrations of lead in game meat did not differ significantly between lead shot and non‑lead shot animals. However, when we analyzed the more elevated lead concentrations, they were significantly higher in edible parts of animals shot with lead ammunition than non-lead ammunition. The highest concentrations were found in samples from edible meat from the area close to the wound channel (max 3442 mg Pb/kg), followed by the saddle (max 1.14 mg Pb/kg) and with the lowest levels in the haunch (max 0.09 mg Pb/kg). A comparison of game species revealed that the lead concentration in haunch and saddle of lead shot red deer was higher than in the corresponding samples of lead shot roe deer. Our results have shown that by the use of non-lead ammunition, a significant reduction of the lead concentration especially in edible parts near the wound channel is possible.

EFSA requested the Scientific Committee to develop a guidance document on the use of the weight of evidence approach in scientific assessments for use in all areas under EFSA's remit. The guidance document addresses the use of weight of evidence approaches in scientific assessments using both qualitative and quantitative approaches. Several case studies covering the various areas under EFSA's remit are annexed to the guidance document to illustrate the applicability of the proposed approach. Weight of evidence assessment is defined in this guidance as a process in which evidence is integrated to determine the relative support for possible answers to a question. This document considers the weight of evidence assessment as comprising three basic steps: (1) assembling the evidence into lines of evidence of similar type, (2) weighing the evidence, (3) integrating the evidence. The present document identifies reliability, relevance and consistency as three basic considerations for weighing evidence., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1295/full

Background Various methods exist for statistical inference about a prevalence that consider misclassifications due to an imperfect diagnostic test. However, traditional methods are known to suffer from truncation of the prevalence estimate and the confidence intervals constructed around the point estimate, as well as from under-performance of the confidence intervals’ coverage. Methods In this study, we used simulated data sets to validate a Bayesian prevalence estimation method and compare its performance to frequentist methods, i.e. the Rogan-Gladen estimate for prevalence, RGE, in combination with several methods of confidence interval construction. Our performance measures are (i) error distribution of the point estimate against the simulated true prevalence and (ii) coverage and length of the confidence interval, or credible interval in the case of the Bayesian method. Results Across all data sets, the Bayesian point estimate and the RGE produced similar error distributions with slight advantages of the former over the latter. In addition, the Bayesian estimate did not suffer from the RGE’s truncation problem at zero or unity. With respect to coverage performance of the confidence and credible intervals, all of the traditional frequentist methods exhibited strong under-coverage, whereas the Bayesian credible interval as well as a newly developed frequentist method by Lang and Reiczigel performed as desired, with the Bayesian method having a very slight advantage in terms of interval length. Conclusion The Bayesian prevalence estimation method should be prefered over traditional frequentist methods. An acceptable alternative is to combine the Rogan-Gladen point estimate with the Lang-Reiczigel confidence interval.

Background: Various methods exist for statistical inference about a prevalence that consider misclassifications due to an imperfect diagnostic test. However, traditional methods are known to suffer from censoring of the prevalence estimate and the confidence intervals constructed around the point estimate, as well as from under-performance of the confidence intervals' coverage. Methods: In this study, we used simulated data sets to validate a Bayesian prevalence estimation method and compare its performance to frequentist methods, i.e. the Rogan-Gladen estimate for prevalence, RGE, in combination with several methods of confidence interval construction. Our performance measures are (i) bias of the point estimate against the simulated true prevalence and (ii) coverage and length of the confidence interval, or credible interval in the case of the Bayesian method. Results: Across all data sets, the Bayesian point estimate and the RGE produced similar bias distributions with slight advanteges of the former over the latter. In addition, the Bayesian estimate did not suffer from the RGE's censoring problem at zero or unity. With respect to coverage performance of the confidence and credible intervals, all of the traditional frequentist methods exhibited strong under-coverage, whereas the Bayesian credible interval as well as a newly developed frequentist method by Lang and Reiczigel performed as desired, with the Bayesian method having a very slight advantage in terms of interval length. Conclusion: The Bayesian prevalence estimation method should be prefered over traditional frequentist methods. An acceptable alternative is to combine the Rogan-Gladen point estimate with the Lang-Reiczigel confidence interval.

To improve and better understand the tire wet grip mechanism, it is essential to perform test bench measurements under wet conditions. On both public streets and the track surfaces of the internal drum test bench of the Karlsruhe Institute of Technology (KIT), a drop in the friction level of the track surface can be observed with an increasing number of wet measurements. For this purpose, a new measuring device was developed and built: the continuous friction monitoring system (CFM-System). The measuring principle is a continuously braked standard test tire, whereby a longitudinal friction coefficient is determined. To establish a suitable measuring method using the CFM-System, a basic understanding of the longitudinal behavior of this standard test tire was achieved. For this purpose, μ-slip characteristics were determined to investigate the friction behavior of this tire under different slip conditions. Furthermore, the influence of wheel load and driving speed were examined and analyzed. Based on these findings, an adequate test method was derived. The investigations presented in this article show a good relation between the results of the CFM-System and the results obtained from measurements using the standard reference test tire (SRTT). The results show that this new CFM-System is suitable for monitoring the grip level of the track surface on the internal drum test bench when performing wet grip measurements. It is assumed that the results can be directly transferred to the real road or to proving grounds because real track surfaces are used on the test bench.

There has been little assessment of the methodological quality of studies measuring the performance (sensitivity and/or specificity) of diagnostic tests for animal diseases. In a systematic review, 190 studies of tests for bovine tuberculosis (bTB) in cattle (published 1934–2009) were assessed by at least one of 18 reviewers using the QUADAS (Quality Assessment of Diagnostic Accuracy Studies) checklist adapted for animal disease tests. VETQUADAS (VQ) included items measuring clarity in reporting (n = 3), internal validity (n = 9) and external validity (n = 2). A similar pattern for compliance was observed in studies of different diagnostic test types. Compliance significantly improved with year of publication for all items measuring clarity in reporting and external validity but only improved in four of the nine items measuring internal validity (p < 0.05). 107 references, of which 83 had performance data eligible for inclusion in a meta-analysis were reviewed by two reviewers. In these references, agreement between reviewers’ responses was 71% for compliance, 32% for unsure and 29% for non-compliance. Mean compliance with reporting items was 2, 5.2 for internal validity and 1.5 for external validity. The index test result was described in sufficient detail in 80.1% of studies and was interpreted without knowledge of the reference standard test result in only 33.1%. Loss to follow-up was adequately explained in only 31.1% of studies. The prevalence of deficiencies observed may be due to inadequate reporting but may also reflect lack of attention to methodological issues that could bias the results of diagnostic test performance estimates. QUADAS was a useful tool for assessing and comparing the quality of studies measuring the performance of diagnostic tests but might be improved further by including explicit assessment of population sampling strategy. UK Department for Environment, Food and Rural Affairs (Defra)

A systematic review was conducted to identify studies with data for statistical meta-analyses of sensitivity (Se) and specificity (Sp) of ante-mortem and post-mortem diagnostic tests for bovine tuberculosis (bTB) in cattle. Members of a working group (WG) developed and tested search criteria and developed a standardised two-stage review process, to identify primary studies with numerator and denominator data for test performance and an agreed range of covariate data. No limits were applied to year, language, region or type of test in initial searches of electronic databases. In stage 1, titles and available abstracts were reviewed. References that complied with stage 1 selection criteria were reviewed in entirety and agreed data were extracted from references that complied with stage 2 selection criteria. At stage 1, 9782 references were reviewed and 261 (2.6%) passed through to stage 2 where 215 English language references were each randomly allocated to two of 18 WG reviewers and 46 references in other languages were allocated to native speakers. Agreement regarding eligibility between reviewers of the same reference at stage 2 was moderate (Kappa statistic = 0.51) and a resolution procedure was conducted. Only 119 references (published 1934-2009) were identified with eligible performance estimates for one or more of 14 different diagnostic test types; despite a comprehensive search strategy and the global impact of bTB. Searches of electronic databases for diagnostic test performance data were found to be nonspecific with regard to identifying references with diagnostic test Se or Sp data. Guidelines for the content of abstracts to research papers reporting diagnostic test performance are presented. The results of meta-analyses of the sensitivity and specificity of the tests, and of an evaluation of the methodological quality of the source references, are presented in accompanying papers (Nuñez-Garcia et al., 2017; Downs et al., 2017).

ZusammenfassungCampylobacter spp. sind Bakterien, die weltweit als einer der häufigsten Auslöser für eine Gastroenteritis gelten und zu schwerwiegenden Folgeerkrankungen führen können. Die Krankheitslast durch Campylobacterbakterien wurde bereits in mehreren Studien mithilfe der quantitativen Maßzahl disability-adjusted life years (DALY) für ausgewählte Länder berechnet. Ziel der Übersichtsarbeit ist es zu evaluieren, ob die berechneten DALYs in den betrachten Ländern und Zeiträume vergleichbar sind und wenn nicht, welche Faktoren die Schätzungen beeinflussen. Da als wichtigster Übertragungsweg für Campylobacter spp. Lebensmittel gelten, wurden auch Publikationen in die Suche einbezogen, die nur die lebensmittelbedingte Krankheitslast abbildeten. Mithilfe einer systematischen Literatursuche, wurden 21 länderspezifische Publikationen und eine Studie der Weltgesundheitsorganisation im Suchzeitraum 1/1996–6/2016 gefunden. Durch unterschiedliche Methoden bei der Berechnung der Krankheitslast sowie die Qualitätsunterschiede der Daten schwanken die Ergebnisse der Schätzungen der Gesamtkrankheitslast in den länderspezifischen Publikationen von 0,4 DALYs in Frankreich bis 109 DALY pro 100000 Einwohner in Polen. Da die Berechnung des attributablen Risikos auf Grundlage der mit Unsicherheiten behafteten Schätzungen der Inzidenzen der campylobacterbedingten Erkrankungen erfolgt, zeigen sich auch bei der lebensmittelbedingten Krankheitslast große Spannweiten von 0,5 DALYs pro 100000 Einwohner in Griechenland bis 21,2 DALY pro 100000 Einwohner in Neuseeland, welche nicht ausschließlich auf die länderspezifischen Variabilität in der Produktion, dem Verzehrsverhalten und dem Vorkommen von Campylobacter spp. zurückzuführen sind.

Die Exposition der Bevolkerung gegenuber chemischen Stoffen in Lebensmitteln wird anhand von reprasentativen Verzehrdaten auf der einen und Gehaltsdaten von Stoffen in Lebensmitteln auf der anderen Seite geschatzt. Die derzeitige Datengrundlage auf Seiten der Verzehrdaten fur verschiedene Altersgruppen wird durch die Nationale Verzehrsstudie ll, VELS, EsKiMo und die zur Zeit durchgefuhrte KiESEL-Studie abgedeckt. Die Datengrundlage fur die Gehaltsdaten, die vor allem durch das Lebensmittel-Monitoring und den Bundeslebensmittelschlussel bezogen werden, ist jedoch nicht hinreichend fur eine vollstandige Bewertung der Exposition uber Lebensmittel in Deutschland. Um die Unsicherheiten der Schatzungen zu reduzieren und die Anzahl der Stoffe mit belastbaren Daten zu vergrosern, wird die Erhebung weiterer Daten unerlasslich. Eine reprasentative Datengrundlage fur die Schatzung der Exposition wird die erste deutsche Total-Diet-Studie, die BfR-MEAL-Studie, liefern. Die BfR-MEAL-Studie wird durch die Einbeziehung verarbeiteter Lebensmittel, durch die Orientierung an moglichst geringen Messgrenzen sowie die Bestimmung von Stoffen, die bislang nicht ausreichend untersucht wurden, die groseren Unsicherheiten der Expositionsschatzung deutlich minimieren.

To date, there are no publicly available schemes designed and evaluated specifically for severity assessment of animal poisonings. This poses challenges for the evaluation and comparison of animal poisoning exposure data.Our objective for this pilot study was to evaluate agreement between raters using the Poisoning Severity Score (PSS) and National Poison Data System (NPDS) medical outcome scheme for severity assessment of canine exposures reported to a multistate poison center (PC) and to identify issues regarding their use for severity assessment of animal poisonings. Agreement between both schemes was also assessed.The first 196 canine exposures reported to a multistate PC between 1 January and 31 August 2016 were selected and initial inquiry data from exposures was scored by four independent raters. Interrater agreement and agreement between the severity systems was calculated using weighted kappa (Κ) (Light's kappa). Reported clinical effects were also described.Interrater agreement for both the PSS (Κ 0.31; 95% CI 0.19, 0.43) and NPDS schemes (Κ 0.34; 95% CI 0.22, 0.44) was low. Agreement between the schemes was slight (Κ 0.05; 95% CI -0.08, 0.16) for pooled results from all four raters. For the PSS, 71.7% (n = 281) of ratings were minor, 23.0% (n = 90) moderate, and 5.4% (n = 21) severe. For the NPDS, 69.6% (n = 273) of ratings were minor, 27.0% (n = 106) moderate, and 3.3% (n = 13) severe. The top three reported clinical effects included vomiting (n = 86, 29.9%) drowsiness/lethargy (n = 38, 13.2%), and diarrhea (n = 24, 8.3%).This study shows considerable variability between raters using either the PSS or NPDS schemes for canine exposures severity assessment. The subjective nature of the schemes, the influence of intra- and interrater variation, and predominance of minor cases on the study findings should be taken into account when interpreting this data. Further evaluation of these schemes is warranted and could help inform their future use for animal poisoning severity assessment.

A quantitative risk assessment was undertaken following the Codex Alimentarius principles in order to predict the exposure of consumers to hepatitis E virus (HEV) through food consumption. Taking into account the tropism of HEV, fresh liver and liver sausages were regarded as having a higher risk of contamination. The model entailed a hypothetical food pathway and was based on worst case scenario where the intake of contaminated food derived from a 100% HEV-infected pig population was estimated. As no data on the prevalence of infectious HEV was available, the HEV-RNA prevalence in food matrices and the seroprevalence of HEV-specific antibodies in swine were assessed and adjusted for diagnostic misclassification and sampling uncertainty. Considering a HEV prevalence of 100% in pigs and excluding further cross-contamination events, a food portion consisting of 130 gr of liver or of 32.5 gr of sausage (containing 30% of liver) yielded an estimated exposure of 8047 and 210 RNA copies (median values), respectively. These findings take into account the effect of thermal treatment on the HEV-RNA concentration of food. Due to the lack of information concerning the correlation between HEV-RNA concentration and the amount of infectious virus as well as the dose-response relationship of HEV, the calculated RNA copies do not allow direct conclusions to be drawn on the risk of infection following ingestion of these food types. The true prevalence was estimated for Switzerland and Germany, leading to an overall prevalence of HEV-RNA in food of 6.2% (90% Highest Density Intervals (HDIs): 2.5%–11.2%). In comparison with fresh liver, liver sausages showed a higher prevalence, most likely due to the presence of more than one liver within the same sausage. The true prevalence of anti-HEV IgG ranged between 59.4% (HDIs 56.5%–62.4%) and 62.6% (HDIs 58.8%–64.3%) and between 7.6% (HDIs 3.3%–13.2%) and 30.5% (HDIs 23.2%–38.2%) in pigs and wild boars, respectively. The high prevalence of antibodies support the evidence that these animals can act as reservoirs for HEV and can contribute epidemiologically to the maintenance of the virus in the surroundings. This study is a preliminary investigation and highlights the major existing gaps needed to be filled in order to enable a refined HEV risk assessment that can drive future decisions for the implementation of food safety and of control measures.

The Animal Study Registry (ASR; www.animalstudyregistry.org) was launched in January 2019 for preregistration of animal studies in order to increase transparency and reproducibility of bioscience research and to promote animal welfare. The registry is free of charge and is designed for exploratory and confirmatory studies within applied science as well as basic and preclinical research. The registration form helps scientists plan their study thoroughly by asking detailed questions concerning study design, methods, and statistics. With registration, the study automatically receives a digital object identifier (DOI) that marks it as intellectual property of the researcher. To accommodate the researchers concerns about theft of ideas, users can restrict the visibility of their registered studies for up to 5 years. The full content of the study becomes publicly accessible at the end of the embargo period. Because the platform is embedded in the infrastructure of the German Federal Government, continuity and data security are provided. By registering a study in the ASR, researchers can show their commitment to transparency and data quality to reviewers and editors, to third-party donors, and to the general public., This Community Page article presents the Animal Study Registry (www.animalstudyregistry.org), which was launched in January 2019 for pre-registration of animal studies in order to increase transparency and reproducibility of bioscience research and to promote animal welfare.

Aluminium is one of the most abundant elements in earth’s crust and its manifold uses result in an exposure of the population from many sources. Developmental toxicity, effects on the urinary tract and neurotoxicity are known effects of aluminium and its compounds. Here, we assessed the health risks resulting from total consumer exposure towards aluminium and various aluminium compounds, including contributions from foodstuffs, food additives, food contact materials (FCM), and cosmetic products. For the estimation of aluminium contents in foodstuff, data from the German “Pilot-Total-Diet-Study” were used, which was conducted as part of the European TDS-Exposure project. These were combined with consumption data from the German National Consumption Survey II to yield aluminium exposure via food for adults. It was found that the average weekly aluminium exposure resulting from food intake amounts to approx. 50% of the tolerable weekly intake (TWI) of 1 mg/kg body weight (bw)/week, derived by the European Food Safety Authority (EFSA). For children, data from the French “Infant Total Diet Study” and the “Second French Total Diet Study” were used to estimate aluminium exposure via food. As a result, the TWI can be exhausted or slightly exceeded—particularly for infants who are not exclusively breastfed and young children relying on specially adapted diets (e.g. soy-based, lactose free, hypoallergenic). When taking into account the overall aluminium exposure from foods, cosmetic products (cosmetics), pharmaceuticals and FCM from uncoated aluminium, a significant exceedance of the EFSA-derived TWI and even the PTWI of 2 mg/kg bw/week, derived by the Joint FAO/WHO Expert Committee on Food Additives, may occur. Specifically, high exposure levels were found for adolescents aged 11–14 years. Although exposure data were collected with special regard to the German population, it is also representative for European and comparable to international consumers. From a toxicological point of view, regular exceedance of the lifetime tolerable aluminium intake (TWI/PTWI) is undesirable, since this results in an increased risk for health impairments. Consequently, recommendations on how to reduce overall aluminium exposure are given.

As a result of decentralized and non-harmonized documentation of poisoning cases within Germany, in comparison to other countries (e.g. the USA, Switzerland, Sweden, and the Netherlands), there is a substantial lack of harmonized national data, in particular for the early detection and risk assessment at the German Federal Institute for Risk Assessment (BfR).The establishment of a national monitoring system for poisonings in Germany is therefore an important step towards enabling faster and more efficient technical access to consolidated accumulated national poisoning data. Additionally, the monitoring would consolidate the publication of annual reports (modelled on the USA National Poison Data System reports) of the German Poison Information Centres and the BfR. Timely assessment of poisoning cases enables fast recognition and confirmation of acute as well as previously unrecognized poisoning hazards. Also relevant here is the safety of products and the associated protection, especially of children, against poisoning accidents.The continuous monitoring and reporting requirements of such a system necessitate additional and challenging work, suitable human resources and IT infrastructure and an annual budget that must be taken into consideration for overall as well as financial planning.

The BfR MEAL Study is the first German total diet study and will establish a representative and comprehensive database for dietary exposure assessment in Germany. The present study reports first results of the BfR MEAL Study regarding methylmercury in fish, seafood and mushrooms. In total, 34 MEAL foods were purchased nationally or regionally according to a defined sampling plan, prepared in a representative way for German households, pooled into 49 samples, homogenized and subjected to ICP-MS analysis. Dogfish, tuna, ocean perch, halibut and eel were the fish species with highest MeHg concentrations, while levels in mushrooms and mushroom products had markedly lower MeHg levels. Exposure was estimated by matching the present results with consumption data at appropriate levels of food group aggregation. MeHg exposure for adult high consumers (P 95) exceeded the tolerable weekly intake recommended by the European Food Safety Authority in two age groups (14-17 and 18-24 years). In children, no age group exceeded the recommended tolerable weekly intake. Regional samples differed only slightly in MeHg levels. The differences in exposure found in four regions of Germany were influenced by consumption habits rather than MeHg level in the investigated food.

Management of viral diagnostic quality is based on external quality assurance (EQA), where laboratories involved in diagnostics of a targeted virus are offered to analyze a panel of blinded samples. The utility of EQAs is compromised because of the absence of an approach to EQA design which upfront defines acceptance criteria and associated statistical analysis ensuring fair and consistent interpretation. We offer a rigorous statistically based approach for EQA planning. Instead of a conventional performance characteristic (the score) which is calculated as the sum of the points for correctly identified samples in a blinded test panel, Youden index is used as the performance measure. Unlike the score, Youden index requires an estimate of sensitivity and specificity and incorporates the relationship of these performance parameters. Based on the assumption that the coordinator is a reputable expert of viral diagnostics, the performance of the coordinator’s laboratory is defined as a proficiency standard for performance evaluation. The immediate goal of EQA is defined as to obtain a statistically reliable estimation for every laboratory whether its performance meets the proficiency standard, while the overall goal is to match every laboratory to its specific performance level. Dependence of informational capacities of test panel from the panel size and content is quantitatively analyzed and the optimal design and informational capacities of both idealized panels (whose size is not restricted by financial factors) and currently feasible panels are considered. Our approach provides the basis both for rational design of currently feasible EQA test panels and for an increased panel size.

SUMMARYIn 2003/2004 a field trial was conducted in Northern Ireland to assess the diagnostic accuracy of six serological tests for bovine brucellosis caused by Brucella abortus. Whereas between-test comparisons have been used to calculate test performances so far, the present study used a latent class approach to estimate diagnostic test accuracy parameters in the absence of a gold standard for these six tests simultaneously and to estimate the true prevalence, while accounting for clustering in the study population and risk factors for true prevalence. Results obtained in this study with regard to prevalence, sensitivity and specificity were largely in accordance with previous findings. Screening tests (SAT and EDTA) appeared to be the most sensitive; however, at low prevalences the EDTA and CFT showed the highest positive predictive values of all investigated tests. The specificities and negative predictive values of all diagnostic tests were found to be very high. Differences of prevalence between three groups of the study population with different risk of exposure could be attributed to the mode of sampling indicating that a more risk-based sampling will result in a higher prevalence than a cross-sectional sampling mode. Age, dairy status and history of abortion were shown to influence the prediction of the latent true infection status.

In this study, the main objective was to implement an integrative modelling framework in order to support the prioritization and screening of chemicals present in personal care products (PCPs) regarding their potential to expose users across multiple possible pathways. Here, we implemented an exposure-based framework based on product intake fractions (PiFs) calculated using a two-compartment model reproducing the skin uptake and the competing volatilization of chemicals applied on skin during PCP use. The implemented framework enabled to simultaneously and comprehensively accommodate coupled chemical specific parameters (i.e. physical and chemical properties of the candidate chemicals), exposure information specific for product-chemical combinations, and survey data informing on consumer behavior. A case-study, based on the usage pattern data of 22 PCPs investigated among Swiss individuals (Garcia-Hidalgo et al., 2017a) and 113 candidate chemicals chosen for their suspected presence in the PCP categories of interest was defined to evaluate the applicability of the framework. Nonnegative matrix factorization (NMF) and hierarchical clustering were subsequently applied to identify chemicals with the highest exposure potential and to highlight most relevant mixtures of chemicals on the basis of the specific usage patterns of the considered survey individuals.

Bacteria of the genus Campylobacter are an important cause of human illness worldwide. Campylobacter infections are expressed as gastroenteritis and can lead to severe sequelae like reactive arthritis, Guillain-Barré syndrome, irritable bowel syndrome and inflammatory bowel disease. In Germany, Campylobacter-associated gastroenteritis cases are notifiable but there is no reporting obligation for the sequelaes and the disease burden is clearly underestimated. The aim of our study was to quantify reliably the current disease burden of all Campylobacter spp.-associated diseases for Germany with the method of disability-adjusted life years (DALYs). DALYs combine mortality and morbidity in a single summary measure, whereby one DALY represents the loss of one year in full health. For acute gastroenteritis, we estimated 967 DALYs of which only 484 DALYs were detected within the reporting system. Overall, we estimated that 8811 DALYs were caused by the campylobacter-related diseases known so far. 98% of the DALYs were associated with morbidity and 2% with mortality. Mortality was caused by the health outcomes Gastroenteritis and Guillain-Barré syndrome exclusively.

Bovine Tuberculosis (bTB) in cattle is a global health problem and eradication of the disease requires accurate estimates of diagnostic test performance to optimize their efficiency. The objective of this study was, through statistical meta-analyses, to obtain estimates of sensitivity (Se) and specificity (Sp), for 14 different ante-mortem and post-mortem diagnostic tests for bTB in cattle. Using data from a systematic review of the scientific literature (published 1934–2009) diagnostic Se and Sp were estimated using Bayesian logistic regression models adjusting for confounding factors. Random effect terms were used to account for unexplained heterogeneity. Parameters in the models were implemented using Markov Chain Monte Carlo (MCMC), and posterior distributions for the diagnostic parameters with adjustment for covariates (confounding factors) were obtained using the inverse logit function. Estimates for Se and/or Sp of the tuberculin skin tests and the IFN-γ blood test were compared with estimates published 2010–2015. Median Se for the single intradermal comparative cervical tuberculin skin (SICCT) test (standard interpretation) was 0.50 and Bayesian credible intervals (CrI) were wide (95% CrI 0.26, 0.78). Median Sp for the SICCT test was 1.00 (95% CrI 0.99, 1.00). Estimates for the IFN-γ blood test Bovine Purified Protein Derivative (PPD)-Avian PPD and Early Secreted Antigen target 6 and Culture Filtrate Protein 10 (ESAT-6/CFP10) ESAT6/CFP10 were 0.67 (95% CrI 0.49, 0.82) and 0.78 (95% CrI 0.60, 0.90) respectively for Se, and 0.98 (95% CrI 0.96, 0.99) and 0.99 (95% CrI 0.99, 1.00) for Sp. The study provides an overview of the accuracy of a range of contemporary diagnostic tests for bTB in cattle. Better understanding of diagnostic test performance is essential for the design of effective control strategies and their evaluation. UK Department for Environment, Food and Rural Affairs (Defra)