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1.
Environmetrics ; 31(7)2020 Nov.
Article in English | MEDLINE | ID: mdl-36052215

ABSTRACT

Protection and safety authorities recommend the use of model averaging to determine the benchmark dose approach as a scientifically more advanced method compared with the no-observed-adverse-effect-level approach for obtaining a reference point and deriving health-based guidance values. Model averaging however highly depends on the set of candidate dose-response models and such a set should be rich enough to ensure that a well-fitting model is included. The currently applied set of candidate models for continuous endpoints is typically limited to two models, the exponential and Hill model, and differs completely from the richer set of candidate models currently used for binary endpoints. The objective of this article is to propose a general and wide framework of dose response models, which can be applied both to continuous and binary endpoints and covers the current models for both type of endpoints. In combination with the bootstrap, this framework offers a unified approach to benchmark dose estimation. The methodology is illustrated using two data sets, one with a continuous and another with a binary endpoint.

2.
EFSA J ; 22(5): e8809, 2024 May.
Article in English | MEDLINE | ID: mdl-38756349

ABSTRACT

In 2023, 14 Member States were affected by African swine fever (ASF), including Croatia and Sweden where ASF emerged (wild boar outbreaks only) and Greece where ASF re-emerged after being free since 2021. The number of ASF outbreaks among domestic pigs in the EU was five times higher than in 2022, reaching a similar magnitude to that in 2019. This was predominantly driven by the introduction and subsequent spread of ASF in Croatia and its resurgence in Romania, representing 96% of the EU outbreaks. ASF outbreaks in domestic pigs were clearly seasonal in all countries, with 88% of outbreaks reported between July and October. Most of the ASF outbreaks among domestic pigs were detected through clinical suspicion (94%), followed by tracing from affected establishments (3%), and the weekly testing of at least two dead pigs in establishments (3%). In wild boar, a 10% increase in the number of notified outbreaks was observed in the EU in comparison with 2022, with considerable variations between countries. A winter peak was observed only in Poland, Slovakia and Hungary. The epidemiological situation in wild boar improved in Germany and Hungary, as suggested by the decrease in the number of outbreaks and in the proportions of PCR-positive samples from dead wild boar. Overall, 31% of wild boar carcasses found during passive surveillance tested positive by PCR, representing 69% of the ASF outbreaks in wild boar in the EU. In contrast, 0.4% of hunted wild boar tested positive, representing 31% of the outbreaks. Despite the introduction of ASF into new countries and the increase in the number of outbreaks, the size of restricted zones in the EU remained stable, due to the highly clustered outbreaks in Croatia, and the reduction of restricted zones in Poland, Slovakia and Bulgaria (in domestic pigs), and Hungary (in wild boar).

3.
EFSA J ; 22(1): e8488, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38239496

ABSTRACT

The European Commission asked EFSA to update its 2009 risk assessment on arsenic in food carrying out a hazard assessment of inorganic arsenic (iAs) and using the revised exposure assessment issued by EFSA in 2021. Epidemiological studies show that the chronic intake of iAs via diet and/or drinking water is associated with increased risk of several adverse outcomes including cancers of the skin, bladder and lung. The CONTAM Panel used the benchmark dose lower confidence limit based on a benchmark response (BMR) of 5% (relative increase of the background incidence after adjustment for confounders, BMDL05) of 0.06 µg iAs/kg bw per day obtained from a study on skin cancer as a Reference Point (RP). Inorganic As is a genotoxic carcinogen with additional epigenetic effects and the CONTAM Panel applied a margin of exposure (MOE) approach for the risk characterisation. In adults, the MOEs are low (range between 2 and 0.4 for mean consumers and between 0.9 and 0.2 at the 95th percentile exposure, respectively) and as such raise a health concern despite the uncertainties.

4.
EFSA J ; 21(5): e08016, 2023 May.
Article in English | MEDLINE | ID: mdl-37223755

ABSTRACT

This report presents the epidemiological analysis of African swine fever (ASF) during 2022 based on the surveillance and pig population data submitted by the European Union (EU) affected countries and one neighbouring country. Coinciding with regulatory changes and an important decrease in ASF outbreaks in 2022 in the EU, the number of domestic pig samples tested as part of active surveillance decreased by 80%, while the number of samples from passive surveillance almost doubled compared with 2021. Most outbreaks among domestic pigs in the EU were detected by testing clinical suspicions (93% of outbreaks), followed by tracing activities (5%) and weekly testing of the first two dead pigs per establishment (2%). Although most of the wild boar samples came from hunted animals, the probability of detecting PCR-positive animals was much higher in wild boar found dead. The ASF outbreaks among domestic pigs in the EU decreased by 79% while a decrease of 40% in the wild boar cases was observed in comparison with 2021. This was strongly marked in Romania, Poland and Bulgaria, with a reduction of 50-80% compared with 2021. In many countries, an important decrease in the number of pig establishments was observed, especially of small establishments with fewer than 100 pigs. The regional between farm incidence and proportion of pigs lost due to ASF in the EU was in general very low (average of 1%) apart from some regions in Romania. The impact of ASF on wild boar populations was variable, with a decline in wild boar abundance observed in certain countries versus a stable or even increased population after ASF introduction. This supports the negative relationship observed in this report between the proportion of the country with restricted zones due to ASF in wild boar and wild boar hunting bags.

5.
EFSA J ; 20(10): e07620, 2022 Oct.
Article in English | MEDLINE | ID: mdl-36267542

ABSTRACT

The European Commission requested scientific and technical assistance in the preparation of a EU-wide baseline survey protocol for a European Union (EU) coordinated monitoring programme on the prevalence of methicillin-resistant Staphylococcus Aureus (MRSA) in pigs. The objective of the survey is to estimate the MRSA prevalence in batches of fattening pigs at slaughter at both European and national levels, with a 95% level of confidence and a level of precision of 10% considering an expected prevalence of 50%. The survey protocol defines the target population, the sample size for the survey, sample collection requirements, the analytical methods (for isolation, identification, phenotypic susceptibility testing and further genotypic testing of MRSA isolates), the data reporting requirements and the plan of analysis. The samples are to be analysed according to the laboratory protocols available on the European Union Reference Laboratory (EURL-AR) website. Generalised linear models will be used to estimate proportion (with 95% confidence intervals) of batches of slaughter pigs tested positive to MRSA. The necessary data to be reported by the EU Member States to support this baseline survey are presented in three data models. The results of the survey should be reported using the EFSA data collection framework.

6.
EFSA J ; 20(8): e07452, 2022 Aug.
Article in English | MEDLINE | ID: mdl-36034319

ABSTRACT

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the conversion of calcium-l-methylfolate and (6S)-5-methyltetrahydrofolic acid glucosamine salt (collectively called 5-MTHF hereafter) into dietary folate equivalents (DFE). Following a systematic review, the conclusions of the opinion are based on one intervention study in adults for intakes < 400 µg/day and three intervention studies in adults for intakes ≥ 400 µg/day. At intakes below 400 µg/day, folic acid (FA) is assumed to be linearly related to responses of biomarkers of intake and status and is an appropriate comparator for deriving a DFE conversion factor for 5-MTHF. It is proposed to use the same factor as for folic acid for conversion of 5-MTHF into DFE for intakes < 400 µg/day. As such intake levels are unlikely to be exceeded through fortified food consumption, the conversion factor of 1.7 relative to natural food folate (NF) could be applied to 5-MTHF added to foods and to food supplements providing < 400 µg/day. At 400 µg/day, 5-MTHF was found to be more bioavailable than folic acid and a conversion factor of 2 is proposed for this intake level and for higher intakes. The derived DFE equations are DFE = NF + 1.7 × FA + 1.7 × 5-MTHF for fortified foods and food supplements providing intakes < 400 µg/day; and DFE = NF + 1.7 × FA + 2.0 × 5-MTHF for food supplements providing intakes ≥ 400 µg/day. Although this assessment applies to calcium-L-methylfolate and 5-MTHF glucosamine salt, it is considered that the influence of the cation on bioavailability is likely to be within the margin of error of the proposed DFE equations. Therefore, the proposed equations can also be applied to 5-MTHF associated with other cations.

7.
EFSA J ; 20(10): e07584, 2022 Oct.
Article in English | MEDLINE | ID: mdl-36304832

ABSTRACT

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

8.
EFSA J ; 19(3): e06422, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33732388

ABSTRACT

EFSA was asked by the European Commission to provide information on levels of lipophilic shellfish toxins in whole scallops that would ensure levels in edible parts below the regulatory limits after shucking, i.e. removal of non-edible parts. This should include the okadaic acid (OA), the azaspiracid (AZA) and the yessotoxin (YTX) groups, and five species of scallops. In addition, EFSA was asked to recommend the number of scallops in an analytical sample. To address these questions, EFSA received suitable data on the three toxin groups in two scallop species, Aequipecten opercularis and Pecten maximus, i.e. data on individual and pooled samples of edible and non-edible parts from contamination incidents. The majority of the concentration levels were below limit of quantification (LOQ)/limit of detection (LOD), especially in adductor muscle but also in gonads. Shucking in most cases resulted in a strong decrease in the toxin levels. For Pecten maximus, statistical analysis showed that levels in whole scallops should not exceed 256 µg OA eq/kg or 217 µg AZA1 eq/kg to ensure that levels in gonads are below the regulatory limits of 160 µg OA or AZA1 eq/kg with 99% certainty. Such an analysis was not possible for yessotoxins or any toxin in Aequipecten opercularis and an assessment could only be based on upper bound levels. To ensure a 95% correct prediction on whether the level in scallops in an area or lot is correctly predicted to be compliant/non-compliant, it was shown that 10 scallops per sample would be sufficient to predict with 95% certainty if levels of OA-group toxins in the area/lot were 25% below or above the regulatory limit. However, to predict with a 95% certainty for levels between 140 and 180 µg OA eq/kg, a pooled sample of more than 30 scallops would have to be tested.

9.
EFSA J ; 19(8): e06809, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34434288

ABSTRACT

EFSA was asked by the European Commission to provide information on the levels of domoic acid (DA) in whole scallops that would ensure that levels in edible parts are below the regulatory limit after shucking. This should include five species of scallops. In addition, EFSA was asked to recommend the number of scallops to be used in an analytical sample. To address these questions, EFSA received suitable data on DA for only one scallop species, Pecten maximus, i.e. data on pooled samples of edible and non-edible parts. A large part of the concentration levels was above the limit of quantification (LOQ) and only these data were used for the assessment. Shucking in most cases resulted in a strong decrease in the toxin levels. Statistical analysis of the data showed that levels in whole scallops should not exceed 24 mg DA/kg, 59 mg DA/kg and 127 mg DA/kg to ensure that levels in, respectively, gonads, muscle and muscle plus gonads are below the regulatory limit of 20 mg DA/kg with 99% certainty. Such an analysis was not possible for the other scallop species. In the absence of data from member states, published data of variations between scallops were used to calculate the sample size to ensure a 95% correct prediction on whether the level in scallops in an area or lot is correctly predicted to be compliant/non-compliant. It was shown that 10 scallops per sample would be sufficient to predict with 95% certainty if DA levels in the area/lot were twofold below or above the regulatory limit for the highest reported coefficient of variance (CV) of 1.06. To predict with 95% certainty for levels between 15 and 27 mg DA/kg, a pooled sample of more than 30 scallops would have to be tested.

10.
EFSA J ; 19(3): e06419, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33717352

ABSTRACT

EFSA assessed the role of seropositive wild boar in African swine fever (ASF) persistence. Surveillance data from Estonia and Latvia investigated with a generalised equation method demonstrated a significantly slower decline in seroprevalence in adult animals compared with subadults. The seroprevalence in adults, taking more than 24 months to approach zero after the last detection of ASFV circulation, would be a poor indicator to demonstrate the absence of virus circulation. A narrative literature review updated the knowledge on the mortality rate, the duration of protective immunity and maternal antibodies and transmission parameters. In addition, parameters potentially leading to prolonged virus circulation (persistence) in wild boar populations were reviewed. A stochastic explicit model was used to evaluate the dynamics of virus prevalence, seroprevalence and the number of carcasses attributed to ASF. Secondly, the impact of four scenarios on the duration of ASF virus (ASFV) persistence was evaluated with the model, namely a: (1) prolonged, lifelong infectious period, (2) reduction in the case-fatality rate and prolonged transient infectiousness; (3) change in duration of protective immunity and (4) change in the duration of protection from maternal antibodies. Only the lifelong infectious period scenario had an important prolonging effect on the persistence of ASF. Finally, the model tested the performance of different proposed surveillance strategies to provide evidence of the absence of virus circulation (Exit Strategy). A two-phase approach (Screening Phase, Confirmation Phase) was suggested for the Exit Strategy. The accuracy of the Exit Strategy increases with increasing numbers of carcasses collected and tested. The inclusion of active surveillance based on hunting has limited impact on the performance of the Exit Strategy compared with lengthening of the monitoring period. This performance improvement should be reasonably balanced against an unnecessary prolonged 'time free' with only a marginal gain in performance. Recommendations are provided for minimum monitoring periods leading to minimal failure rates of the Exit Strategy. The proposed Exit Strategy would fail with the presence of lifelong infectious wild boar. That said, it should be emphasised that the existence of such animals is speculative, based on current knowledge.

11.
J Clin Microbiol ; 48(4): 1040-6, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20164268

ABSTRACT

Rapid laboratory diagnosis is critical for treating, managing, and preventing methicillin-resistant Staphylococcus aureus (MRSA) infections. We evaluated and compared the potential for MRSA detection of five chromogenic media, Brilliance MRSA agar (Oxoid), ChromID (bioMérieux), MRSASelect (Bio-Rad), CHROMagar (CHROMagar Microbiology), and BBL-CHROMagar (BD Diagnostics). Media were tested with log serial dilutions (10(0) to 10(6) CFU) of pure isolates of MRSA (n = 60), non-MRSA (n = 27), and defined mixtures thereof simulating clinical samples (n = 84). Further evaluations were done on pre-enriched nasal and groin screening swabs (n = 213) from 165 hospitalized patients. Randomized samples were spiral plated on each medium and independently scored by five investigators for characteristic colonies at 24 and 48 h of incubation. Confirmatory testing of up to five putative MRSA colonies recovered from each medium was done. The cumulative average sensitivity with isolates, mixtures, and clinical samples was the highest for Brilliance MRSA agar (97%) and similar for the other four media (>or=92%). The cumulative average specificity was the highest for BBL-CHROMagar (99%), followed by MRSASelect (98%), CHROMagar (97%), ChromID (89%), and Brilliance MRSA agar (86%). All of the media detected MRSA at 10 and 1 CFU, although at these low loads, few MRSA samples harboring SCCmec type III or IV were misinterpreted as non-MRSA by investigators. False-positive results were mainly due to methicillin-resistant S. epidermidis. For an arbitrary MRSA prevalence of 5% and based on patient sample evaluations, the positive predictive values for BBL-CHROMagar and CHROMagar ( approximately 84%) were the highest. The negative predictive values of all of the media were >or=92% for MRSA prevalences ranging from 5% to 30%. In conclusion, BBL-CHROMagar and CHROMagar gave the best overall results for detection of MRSA, irrespective of the sample concentration, investigator, or incubation period.


Subject(s)
Bacteriological Techniques/methods , Culture Media/chemistry , Methicillin-Resistant Staphylococcus aureus/isolation & purification , Staphylococcal Infections/diagnosis , Diagnostic Errors/statistics & numerical data , Groin/microbiology , Humans , Methicillin-Resistant Staphylococcus aureus/growth & development , Nose/microbiology , Predictive Value of Tests , Random Allocation , Sensitivity and Specificity , Staphylococcal Infections/microbiology
12.
J Clin Microbiol ; 48(12): 4598-601, 2010 Dec.
Article in English | MEDLINE | ID: mdl-20943869

ABSTRACT

The diagnostic sensitivities of the BD GeneOhm and Cepheid Xpert assays were compared using culture on log-serial dilutions of well-characterized methicillin-resistant Staphylococcus aureus (MRSA) and non-MRSA strains and on nasal and groin swabs from patients with histories of MRSA carriage. The sensitivities of GeneOhm and Xpert were high at 10(3)-CFU/ml MRSA concentrations (92.3% and 96.3%, respectively) although decreased considerably (<35%) at a 1-log-lower concentration. Unexpectedly, both assays also detected select coagulase-negative staphylococci, which requires further evaluation.


Subject(s)
Bacteriological Techniques/methods , Carrier State/diagnosis , Methicillin-Resistant Staphylococcus aureus/isolation & purification , Molecular Diagnostic Techniques/methods , Staphylococcal Infections/diagnosis , Carrier State/microbiology , Coagulase/genetics , Groin/microbiology , Humans , Nasal Mucosa/microbiology , Sensitivity and Specificity , Staphylococcal Infections/microbiology
13.
J Biopharm Stat ; 20(4): 768-86, 2010 Jul.
Article in English | MEDLINE | ID: mdl-20496205

ABSTRACT

This paper proposes a modified model averaging approach for linear discriminant analysis. This approach is used in combination with a doubly hierarchical supervised learning analysis and applied to preclinical pharmaco-electroencephalographical data for classification of psychotropic drugs. Classification of a test dataset was highly improved with this method.


Subject(s)
Artificial Intelligence , Drug Evaluation, Preclinical/methods , Electroencephalography/drug effects , Models, Statistical , Psychotropic Drugs/pharmacology , Algorithms , Animals , Discriminant Analysis , Likelihood Functions , Linear Models , Psychotropic Drugs/classification , Rats , Regression Analysis , Selection Bias , Sleep Stages/drug effects , Wakefulness/drug effects
14.
Prev Vet Med ; 181: 104595, 2020 Aug.
Article in English | MEDLINE | ID: mdl-30553537

ABSTRACT

Despite the wide use of the live attenuated Neethling lumpy skin disease (LSD) vaccine, only limited data existed on its efficacy and effectiveness prior to the large LSD epidemic in the Balkans, which took place during 2016-2017. In addition, analysis of risk factors for the disease was hardly performed with proper control for vaccination effects and potential differences in exposure to the virus. Data from the LSD epidemics in six Balkan countries (Bulgaria, Greece, Serbia, Montenegro, Former Yugoslav Republic of Macedonia (FYROM) and Albania) affected during 2016 were analyzed to determine vaccine effectiveness (VE) and risk factors for LSD infection at the farm level. Vaccination was performed along the occurrence of the epidemics and thus vaccination status of some of the farms changed during the epidemic. To allow for this, left truncated and right censored survival analysis was used in a mixed effects Cox proportional hazard regression model to calculate VE and risk factors for LSD. The results indicated of an average VE of 79.8% (95% CI: 73.2-84.7)) in the six countries, with the lowest VE of 62.5% documented in Albania and up to VE of more than 97% as documented in Bulgaria and Serbia. Analysis of time from vaccination to development of protective immunity showed that VE mostly developed during the first 14 days after vaccination. Data from Greece showed that the vaccination adjusted hazard ratio for LSD was 5.7 higher in grazing farms compared to non-grazing farms. However, due to a difference in geographical location of grazing and non-grazing farms and higher vaccination rate in non-grazing farms, this effect can be at least partly attributed to indirect protection due to herd immunity provided by surrounding vaccinated farms.


Subject(s)
Lumpy Skin Disease/prevention & control , Lumpy skin disease virus/immunology , Viral Vaccines/administration & dosage , Albania , Animals , Bulgaria , Cattle , Greece , Housing, Animal , Montenegro , Republic of North Macedonia , Risk Factors , Serbia , Survival Analysis , Vaccines, Attenuated/administration & dosage
15.
EFSA J ; 18(3): e06041, 2020 Mar.
Article in English | MEDLINE | ID: mdl-33020705

ABSTRACT

Rift Valley fever (RVF) is a vector-borne disease transmitted by a broad spectrum of mosquito species, especially Aedes and Culex genus, to animals (domestic and wild ruminants and camels) and humans. Rift Valley fever is endemic in sub-Saharan Africa and in the Arabian Peninsula, with periodic epidemics characterised by 5-15 years of inter-epizootic periods. In the last two decades, RVF was notified in new African regions (e.g. Sahel), RVF epidemics occurred more frequently and low-level enzootic virus circulation has been demonstrated in livestock in various areas. Recent outbreaks in a French overseas department and some seropositive cases detected in Turkey, Tunisia and Libya raised the attention of the EU for a possible incursion into neighbouring countries. The movement of live animals is the most important pathway for RVF spread from the African endemic areas to North Africa and the Middle East. The movement of infected animals and infected vectors when shipped by flights, containers or road transport is considered as other plausible pathways of introduction into Europe. The overall risk of introduction of RVF into EU through the movement of infected animals is very low in all the EU regions and in all MSs (less than one epidemic every 500 years), given the strict EU animal import policy. The same level of risk of introduction in all the EU regions was estimated also considering the movement of infected vectors, with the highest level for Belgium, Greece, Malta, the Netherlands (one epidemic every 228-700 years), mainly linked to the number of connections by air and sea transports with African RVF infected countries. Although the EU territory does not seem to be directly exposed to an imminent risk of RVFV introduction, the risk of further spread into countries neighbouring the EU and the risks of possible introduction of infected vectors, suggest that EU authorities need to strengthen their surveillance and response capacities, as well as the collaboration with North African and Middle Eastern countries.

16.
EFSA J ; 18(11): e06292, 2020 Nov.
Article in English | MEDLINE | ID: mdl-33193869

ABSTRACT

Effectiveness of surveillance and control measures against Rift Valley Fever (RVF) in Mayotte (overseas France) and in continental EU were assessed using mathematical models. Surveillance for early detection of RVF virus circulation implies very low design prevalence values and thus sampling a high number of animals, so feasibility issues may rise. Passive surveillance based on notified abortions in ruminants is key for early warning and at present the only feasible surveillance option. The assessment of vaccination and culling against RVF in Mayotte suggests that vaccination is more effective when quickly implemented throughout the population, e.g. at a rate of 200 or 2,000 animals vaccinated per day. Test and cull is not an option for RVF control in Mayotte given the high number of animals that would need to be tested. If the risk of RVFV introduction into the continental EU increases, ruminant establishments close to possible points of disease incursion should be included in the surveillance. An enhanced surveillance on reproductive disorders should be applied during summer in risk areas. Serosurveillance targets of 0.3% animals should be at least considered. RVF control measures possibly applied in the continental EU have been assessed in the Netherlands, as an example. Culling animals on farms within a 20 km radius of detected farms appears as the most effective measure to control RVF spread, although too many animals should be culled. Alternative measures are vaccination in a 50 km radius around detection, ring vaccination between 20 and 50 km and culling of detected farms. The assessment of zoning showed that, following RVFV introduction and considering an R0 = 2, a mean vector dispersal of 10 km and 10 farms initially detected, RVFV would spread beyond a radius of up to 100 km or 50 km from the infected area with 10% or 55% probability, respectively.

17.
Sci Total Environ ; 685: 50-58, 2019 Oct 01.
Article in English | MEDLINE | ID: mdl-31174123

ABSTRACT

Globally, aquaculture products are expected to account for >60% of total seafood produce by 2030. In the European Union, the seafood sector is of considerable economic importance to member states with household spending on seafood produce totalling €54.8 billion in 2016. Within the EU, shellfish aquaculture supports livelihoods and employment in many rural communities throughout the region. Harmful algal blooms pose considerable risk to consumer safety and in turn, stability of the shellfish market. If contaminated produce was to make it to the market the health risk to the public could be considerable, but the damage to the sector through loss of trust in producers would also be significant. Mytilus edulis account for a considerable portion of the aquaculture sector in the Northeast Atlantic. At present, no scientific tool is available to industry regulators, to allow them to trace mussel produce to its source, uphold food safety standards and ensure consumer confidence. The present study uses chemical analysis of shells and soft tissues to classify individual M. edulis to their site of harvest. The use of random forest classification of trace element composition has revealed location specific elemental signatures for all examined sites. This led to the correct classification of 100% of individuals sampled to their respective harvesting locations, including two sites located just 6 km apart within the same bay. The protocol demonstrated here provides the basis for a scientifically driven traceability framework for shellfish produce.


Subject(s)
Environmental Monitoring/methods , Mytilus edulis/chemistry , Trace Elements/analysis , Water Pollutants, Chemical/analysis , Animals , Fisheries/statistics & numerical data
18.
EFSA J ; 17(5): e05665, 2019 May.
Article in English | MEDLINE | ID: mdl-32626299

ABSTRACT

EFSA was asked to update the 2015 EFSA risk assessment on Xylella fastidiosa for the territory of the EU. In particular, EFSA was asked to focus on potential establishment, short- and long-range spread, the length of the asymptomatic period, the impact of X. fastidiosa and an update on risk reduction options. EFSA was asked to take into account the different subspecies and Sequence Types of X. fastidiosa. This was attempted throughout the scientific opinion but several issues with data availability meant that this could only be partially achieved. Models for risk of establishment showed most of the EU territory may be potentially suitable for X. fastidiosa although southern EU is most at risk. Differences in estimated areas of potential establishment were evident among X. fastidiosa subspecies, particularly X. fastidiosa subsp. multiplex which demonstrated areas of potential establishment further north in the EU. The model of establishment could be used to develop targeted surveys by Member States. The asymptomatic period of X. fastidiosa varied significantly for different host and pathogen subspecies combinations, for example from a median of approximately 1 month in ornamental plants and up to 10 months in olive, for pauca. This variable and long asymptomatic period is a considerable limitation to successful detection and control, particularly where surveillance is based on visual inspection. Modelling suggested that local eradication (e.g. within orchards) is possible, providing sampling intensity is sufficient for early detection and effective control measures are implemented swiftly (e.g. within 30 days). Modelling of long-range spread (e.g. regional scale) demonstrated the important role of long-range dispersal and the need to better understand this. Reducing buffer zone width in both containment and eradication scenarios increased the area infected. Intensive surveillance for early detection, and consequent plant removal, of new outbreaks is crucial for both successful eradication and containment at the regional scale, in addition to effective vector control. The assessment of impacts indicated that almond and Citrus spp. were at lower impact on yield compared to olive. Although the lowest impact was estimated for grapevine, and the highest for olive, this was based on several assumptions including that the assessment considered only Philaenus spumarius as a vector. If other xylem-feeding insects act as vectors the impact could be different. Since the Scientific Opinion published in 2015, there are still no risk reduction options that can remove the bacterium from the plant in open field conditions. Short- and long-range spread modelling showed that an early detection and rapid application of phytosanitary measures, consisting among others of plant removal and vector control, are essential to prevent further spread of the pathogen to new areas. Further data collection will allow a reduction in uncertainty and facilitate more tailored and effective control given the intraspecific diversity of X. fastidiosa and wide host range.

19.
J Biopharm Stat ; 18(6): 1120-35, 2008.
Article in English | MEDLINE | ID: mdl-18991112

ABSTRACT

This paper proposes a general and simple procedure that can be applied to establish classification rules for application to multiple-class longitudinal data. The procedure is applied to preclinical pharmaco-electroencephalogram (EEG) studies aiming at characterizing psychotropic drug effects on the basis of spectral EEG analysis. It is a flexible hierarchical supervised learning tool that takes into account the specific nature of the multiple drug classes, as well as the longitudinal aspect of the data. Several variations of this procedure are applied to the EEG data, generally producing comparable results, in particular similar association between the sleeping stages and the psychotropic drug classes.


Subject(s)
Discriminant Analysis , Drug Evaluation, Preclinical/statistics & numerical data , Electroencephalography/statistics & numerical data , Models, Statistical , Psychotropic Drugs/pharmacology , Sleep/drug effects , Wakefulness/drug effects , Animals , Dose-Response Relationship, Drug , Linear Models , Longitudinal Studies , Models, Animal , Psychotropic Drugs/classification , Rats , Reproducibility of Results , Time Factors
20.
Prev Vet Med ; 83(3-4): 323-36, 2008 Mar 17.
Article in English | MEDLINE | ID: mdl-17961763

ABSTRACT

Since the 1980s, the prevalence of Salmonella in Belgian poultry layers and broilers has greatly fluctuated with a rise observed in 2003 and a significant decrease in 2005. In order to alleviate the risk at egg consumer level, it is crucial to understand the factors which influence the contamination and the spread of Salmonella in laying hens. To study such determinants we explored the Belgian data from the 2005 baseline study on the prevalence of Salmonella in laying flocks of Gallus gallus in the European Union. The response variables corresponded to presence or absence of Salmonella from dust and faecal samples taken from the environment of a Belgian layer flock. The explanatory variables included: region of Belgium, sampling time (month the flock was sampled), production type (cage or barn and free range), Salmonella vaccination status, flock age and flock size. Analyses of these data were performed using a bivariate logistic regression model assuming independence between the two responses and bivariate generalized estimating equations model, which incorporates the correlation between the two responses on the same flock. The main risk factor that was identified was rearing flocks in cages compared to barns and free-range systems. The results also showed a significant higher risk for Salmonella for a 1 week increase in flocks' age as well as with a unit increase in the size of the flock.


Subject(s)
Chickens , Consumer Product Safety , Eggs/microbiology , Poultry Diseases/epidemiology , Salmonella Infections, Animal/epidemiology , Animal Husbandry/methods , Animals , Belgium , Feces/microbiology , Female , Logistic Models , Prevalence , Risk Factors , Seasons
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