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The qualified presumption of safety (QPS) provides a generic pre-assessment of the safety of microorganisms intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. QPS assessment allows a fast track evaluation of strains belonging to QPS taxonomic units (TUs): species for bacteria, yeast, fungi, protists/microalgae and families for viruses. QPS TUs are assessed for their body of knowledge and safety. Safety concerns related to a QPS TU are reflected, when possible, as ‘qualifications’, which should be tested at strain and/or product level. Based on the possession of potentially harmful traits by some strains, filamentous fungi, bacteriophages, oomycetes, streptomycetes, Enterococcus faecium, Escherichia coli and Clostridium butyricum are excluded from the QPS assessment. Between October 2019 and September 2022, 323 notifications of TUs were received, 217 related to feed additives, 54 to food enzymes, food additives and flavourings, 14 to plant protection products and 38 to novel foods. The list of QPS-recommended TUs is reviewed every 6 months following an extensive literature search strategy. Only sporadic infections with a few QPS status TUs in immunosuppressed individuals were identified and the assessment did not change the QPS status of these TUs. The QPS list has been updated in relation to the most recent taxonomic insights and the qualifications were revised and streamlined. The qualification ‘absence of aminoglycoside production ability’ was withdrawn for Bacillus velezensis. Six new TUs received the QPS status: Bacillus paralicheniformis with the qualification ‘absence of toxigenic activity’ and ‘absence of bacitracin production ability’; Bacillus circulans with the qualifications for ‘production purposes only’ and ‘absence of cytotoxic activity’; Haematococcus lacustris (synonym Haematococcus pluvialis) and Ogataea polymorpha, both with the qualification ‘for production purposes only’; Lactiplantibacillus argento

The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of microorganisms intended for use in the food or feed chains. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’ which should be assessed at strain and/or product level by EFSA's Scientific Panels. The generic qualification ‘the strains should not harbour any acquired antimicrobial resistance (AMR) genes to clinically relevant antimicrobials’ applies to all QPS bacterial TUs. The different EFSA risk assessment areas use the same approach to assess the qualification related to AMR genes. In this statement, the terms ‘intrinsic’ and ‘acquired’ AMR genes were defined for the purpose of EFSA's risk assessments, and they apply to bacteria used in the food and feed chains. A bioinformatic approach is proposed for demonstrating the ‘intrinsic’/’acquired’ nature of an AMR gene. All AMR genes that confer resistance towards ‘critically important’, ‘highly important’ and ‘important’ antimicrobials, as defined by the World Health Organisation (WHO), found as hits, need to be considered as hazards (for humans, animals and environment) and need further assessment. Genes identified as responsible for ‘intrinsic’ resistance could be considered as being of no concern in the frame of the EFSA risk assessment. ‘Acquired’ AMR genes resulting in a resistant phenotype should be considered as a concern. If the presence of the ‘acquired’ AMR gene is not leading to phenotypic resistance, further case-by-case assessment is necessary.

The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of microorganisms, intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’. In the period covered by this Statement, no new information was found that would change the status of previously recommended QPS TUs. Of 38 microorganisms notified to EFSA between October 2022 and March 2023 (inclusive) (28 as feed additives, 5 as food enzymes, food additives and flavourings, 5 as novel foods), 34 were not evaluated because: 8 were filamentous fungi, 4 were Enterococcus faecium and 2 were Escherichia coli (taxonomic units that are excluded from the QPS evaluation) and 20 were taxonomic units (TUs) that already have a QPS status. Three of the other four TUs notified within this period were evaluated for the first time for a possible QPS status: Anaerobutyricum soehngenii, Stutzerimonas stutzeri (former Pseudomonas stutzeri) and Nannochloropsis oculata. Microorganism strain DSM 11798 has also been notified in 2015 and as its taxonomic unit is notified as a strain not a species, it is not suitable for the QPS approach. A. soehngenii and N. oculata are not recommended for the QPS status due to a limited body of knowledge of its use in the food and feed chains. S. stutzeri is not recommended for inclusion in the QPS list based on safety concerns and limited information about the exposure of animals and humans through the food and feed chains.

The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of microorganisms, intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’. In the period covered by this Statement, new information was found leading to the withdrawal of the qualification ‘absence of aminoglycoside production ability’ for Bacillus velezensis. The qualification for Bacillus paralicheniformis was changed to ‘absence of bacitracin production ability’. For the other TUs, no new information was found that would change the status of previously recommended QPS TUs. Of 52 microorganisms notified to EFSA between April and September 2022 (inclusive), 48 were not evaluated because: 7 were filamentous fungi, 3 were Enterococcus faecium, 2 were Escherichia coli, 1 was Streptomyces spp., and 35 were taxonomic units (TUs) that already have a QPS status. The other four TUs notified within this period, and one notified previously as a different species, which was recently reclassified, were evaluated for the first time for a possible QPS status: Xanthobacter spp. could not be assessed because it was not identified to the species level; Geobacillus thermodenitrificans is recommended for QPS status with the qualification ‘absence of toxigenic activity’. Streptoccus oralis is not recommended for QPS status. Ogataea polymorpha is proposed for QPS status with the qualification ‘for production purposes only’. Lactiplantibacillus argentoratensis (new species) is included in the QPS list.

The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance were assessed. Safety concerns identified for a taxonomic unit (TU) are, where possible and reasonable in number, reflected by ‘qualifications’ which should be assessed at the strain level by the EFSA's Scientific Panels. During the current assessment, no new information was found that would change the previously recommended QPS TUs and their qualifications. The list of microorganisms notified to EFSA from applications for market authorisation was updated with 47 biological agents, received between October 2018 and March 2019. Of these, 19 already had QPS status, 20 were excluded from the QPS exercise by the previous QPS mandate (11 filamentous fungi) or from further evaluations within the current mandate (9 notifications of Escherichia coli). Sphingomonas elodea, Gluconobacter frateurii, Corynebacterium ammoniagenes, Corynebacterium casei, Burkholderia ubonensis, Phaeodactylum tricornutum, Microbacterium foliorum and Euglena gracilis were evaluated for the first time. Sphingomonas elodea cannot be assessed for a possible QPS recommendation because it is not a valid species. Corynebacterium ammoniagenes and Euglena gracilis can be recommended for the QPS list with the qualification ‘for production purposes only’. The following TUs cannot be recommended for the QPS list: Burkholderia ubonensis, due to its potential and confirmed ability to generate biologically active compounds and limited of body of knowledge; Corynebacterium casei, Gluconobacter frateurii and Microbacterium foliorum, due to lack of body of knowledge; Phaeodactylum tricornutum, based on the lack of a safe history of use in the food chain and limited knowledge on its potential production of bioactive compounds

The qualified presumption of safety (QPS) concept was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA's scientific Panels. The identity, body of knowledge, safety concerns and antimicrobial resistance of valid taxonomic units were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, considered to be qualifications' which should be assessed at the strain level by the EFSA's scientific Panels. No new information was found that would change the previously recommended QPS taxonomic units and their qualifications. The BIOHAZ Panelconfirms that the QPS approach can be extended to a genetically modified production strain if the recipient strain qualifies for the QPS status, and if the genetic modification does not indicate a concern. Between April and September 2017, the QPS notification list was updated with 46 applications for market authorisation. From these, 14 biological agents already had QPS status and 16 were not included as they are filamentous fungi or enterococci. One notification of Streptomyces K-61 (notified as former S.griseoviridis) and four of Escherichia coli were not considered for the assessment as they belong to taxonomic units that were excluded from further evaluations within the current QPS mandate. Eight notifications of Bacillus thuringiensis and one of an oomycete are pending the reception of the complete application. Two taxonomic units were evaluated: Kitasatosporaparacochleata, which had not been evaluated before, and Komagataellaphaffii, previously notified as Pichia pastoris included due to a change in the taxonomic identity. Kitasatosporaparacochleata cannot be granted QPS status due to lack of information on its biology and to its possible production of toxic secondary metabolites. The species Komagataellaphaffii can be recommended for the QPS list when used for enzyme production. (c) 2018 European Food Safe

Parasites are important food‐borne pathogens. Their complex lifecycles, varied transmission routes, and prolonged periods between infection and symptoms mean that the public health burden and relative importance of different transmission routes are often difficult to assess. Furthermore, there are challenges in detection and diagnostics, and variations in reporting. A Europe‐focused ranking exercise, using multicriteria decision analysis, identified potentially food‐borne parasites of importance, and that are currently not routinely controlled in food. These are Cryptosporidium spp., Toxoplasma gondii and Echinococcus spp. Infection with these parasites in humans and animals, or their occurrence in food, is not notifiable in all Member States. This Opinion reviews current methods for detection, identification and tracing of these parasites in relevant foods, reviews literature on food‐borne pathways, examines information on their occurrence and persistence in foods, and investigates possible control measures along the food chain. The differences between these three parasites are substantial, but for all there is a paucity of well‐established, standardised, validated methods that can be applied across the range of relevant foods. Furthermore, the prolonged period between infection and clinical symptoms (from several days for Cryptosporidium to years for Echinococcus spp.) means that source attribution studies are very difficult. Nevertheless, our knowledge of the domestic animal lifecycle (involving dogs and livestock) for Echinoccocus granulosus means that this parasite is controllable. For Echinococcus multilocularis, for which the lifecycle involves wildlife (foxes and rodents), control would be expensive and complicated, but could be achieved in targeted areas with sufficient commitment and resources. Quantitative risk assessments have been described for Toxoplasma in meat. However, for T. gondii and Cryptosporidium as faecal contaminants, development of validate

The Stommel box model elegantly demonstrates that the oceanic response to mixed boundary conditions, combining a temperature relaxation with a fixed salt flux forcing, is nonlinear owing to the so-called salt advection feedback. This nonlinearity produces a parameter range of bi-stability associated with hysteresis effects characterised by a fast thermally-driven mode and a slow salinity-driven mode. Here we investigate whether a similar dynamical behaviour can be found in the thermohaline loop model, a one-dimensional analogue of the box model. A semi-analytical method to compute possible steady states of the loop model is presented, followed by a linear stability analysis carried out for a large range of loop configurations. While the salt advection feedback is found as in the box model, a major difference is obtained for the fast mode: an oscillatory instability is observed near the turning point of the fast mode branch, such that the range of bi-stability is systematically reduced, or even removed, in some cases. The oscillatory instability originates from a salinity anomaly that grows exponentially as it turns around the loop, a situation that may occur only when the salinity torque is directed against the loop flow. Factors such as mixing intensity, the relative strength of thermal and haline forcings, the nonlinearity of the equation of state or the loop geometry can strongly affect the stability properties of the loop.

EFSA is requested to assess the safety of a broad range of biological agents in the context of notification for market authorisation as sources of food and feed additives, food enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide a harmonised generic preassessment to support safety risk assessments performed by EFSA's scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended), and the completeness of the body of knowledge are assessed. Identified safety concerns for a taxonomic unit are, where possible and reasonable in number, reflected as 'qualifications' in connection with a recommendation for a QPS status. The list of QPS recommended biological agents was reviewed and updated in the current opinion and therefore becomes the valid list. The 2016 update reviews previously assessed microorganisms including bacteria, yeasts and viruses used for plant protection purposes following an Extensive Literature Search strategy. The taxonomic units related to the new notifications received since the 2013 QPS opinion, were periodically evaluated for a QPS status and the results published as Statements of the BIOHAZ Panel. Carnobacterium divergens, Lactobacillus diolivorans, Microbacterium imperiale, Pasteuria nishizawae, Pediococcus parvulus, Bacillus flexus, Bacillus smithii, Xanthomonas campestris and Candida cylindracea were recommended for the QPS list. All taxonomic units previously recommended for the 2013 QPS list had their status reconfirmed as well their qualifications with the exception of Pasteuria nishizawae for which the qualification was removed. The exclusion of filamentous fungi and enterococci from the QPS evaluations was reconsidered but monitoring will be maintained and the status will be re-evaluated in the next QPS Opinion update. Evaluation of bacteriophages should remain as a case

EFSA and EMA have jointly reviewed measures taken in the EU to reduce the need for and use of antimicrobials in food-producing animals, and the resultant impacts on antimicrobial resistance (AMR). Reduction strategies have been implemented successfully in some Member States. Such strategies include national reduction targets, benchmarking of antimicrobial use, controls on prescribing and restrictions on use of specific critically important antimicrobials, together with improvements to animal husbandry and disease prevention and control measures. Due to the multiplicity of factors contributing to AMR, the impact of any single measure is difficult to quantify, although there is evidence of an association between reduction in antimicrobial use and reduced AMR. To minimise antimicrobial use, a multifaceted integrated approach should be implemented, adapted to local circumstances. Recommended options (non-prioritised) include: development of national strategies; harmonised systems for monitoring antimicrobial use and AMR development; establishing national targets for antimicrobial use reduction; use of on-farm health plans; increasing the responsibility of veterinarians for antimicrobial prescribing; training, education and raising public awareness; increasing the availability of rapid and reliable diagnostics; improving husbandry and management procedures for disease prevention and control; rethinking livestock production systems to reduce inherent disease risk. A limited number of studies provide robust evidence of alternatives to antimicrobials that positively influence health parameters. Possible alternatives include probiotics and prebiotics, competitive exclusion, bacteriophages, immunomodulators, organic acids and teat sealants. Development of a legislative framework that permits the use of specific products as alternatives should be considered. Further research to evaluate the potential of alternative farming systems on reducing AMR is also recommended. Animals s

Metrology is the science of measurements; production engineering metrology is the science of applied metrology in production and in product realization. In this paper the automotive, construction equipment and aerospace industry are particularly addressed. One theoretical and practical approach to geometrical part quality assurance focusing on manufacturing processes and systematic work and use of objective, value adding production engineering metrology is proposed. This paper aims to describe a practical approach on how to carry out geometrical assurance of parts produced in manufacturing processes using traditional production methods. One example using machining, i.e. turning, of a part is used to explain this approach., Correspondence Address: Lindqvist, R.P.; KTH, Department of Production Engineering, Brinellvägen 68, Sweden; email: ricli@kth.se. QC 20161102

Item does not contain fulltext, BACKGROUND: Despite concerns as to whether nurses can perform reliably and effectively when working longer shifts, a pattern of two 12- to 13-hour shifts per day is becoming common in many hospitals to reduce shift to shift handovers, staffing overlap, and hence costs. OBJECTIVES: To describe shift patterns of European nurses and investigate whether shift length and working beyond contracted hours (overtime) is associated with nurse-reported care quality, safety, and care left undone. METHODS: Cross-sectional survey of 31,627 registered nurses in general medical/surgical units within 488 hospitals across 12 European countries. RESULTS: A total of 50% of nurses worked shifts of /= 12 hours. Typical shift length varied between countries and within some countries. Nurses working for >/= 12 hours were more likely to report poor or failing patient safety [odds ratio (OR)=1.41; 95% confidence interval (CI), 1.13-1.76], poor/fair quality of care (OR=1.30; 95% CI, 1.10-1.53), and more care activities left undone (RR=1.13; 95% CI, 1.09-1.16). Working overtime was also associated with reports of poor or failing patient safety (OR=1.67; 95% CI, 1.51-1.86), poor/fair quality of care (OR=1.32; 95% CI, 1.23-1.42), and more care left undone (RR=1.29; 95% CI, 1.27-1.31). CONCLUSIONS: European registered nurses working shifts of >/= 12 hours and those working overtime report lower quality and safety and more care left undone. Policies to adopt a 12-hour nursing shift pattern should proceed with caution. Use of overtime working to mitigate staffing shortages or increase flexibility may also incur additional risk to quality.

Background: The present shortage of registered nurses (RNs) in many European countries is expected to continue and worsen, which poses a substantial threat to the maintenance of healthcare in this region. Work-family conflict is a known risk factor for turnover and sickness absence. Objective: This paper empirically examines whether the nurse practice environment is associated with experienced work-family conflict. Design: A multilevel model was fit with the individual RN at the 1st, and the hospital department at the 2nd level using cross-sectional RN survey data from the Swedish part of RN4CAST, an EU 7th framework project. The data analyzed here is based on a national sample of 8356 female and 592 male RNs from 369 hospital departments. Results: We found that 6% of the variability in work-family conflict experienced by RNs was at the department level. Organizational level factors significantly accounted for most of the variability at this level with two of the work practice environment factors examined, staffing adequacy and nurse involvement in hospital affairs, significantly related to work-family conflict. Due to the design of the study, factors on ward and work group levels could not be analyzed, but are likely to account for additional variance which in the present analysis appears to be on the individual level, with private life factors likely explaining another major part. Conclusion: These results suggest that higher level organizational factors in health care have a significant impact on the risk of work-family conflict among RNs through their impact on the nurse practice environment. Lower level organizational factors should be investigated in future studies using hierarchical multilevel sampling.

Item does not contain fulltext, BACKGROUND: As health services research (HSR) expands across the globe, researchers will adopt health services and health worker evaluation instruments developed in one country for use in another. This paper explores the cross-cultural methodological challenges involved in translating HSR in the language and context of different health systems. OBJECTIVES: To describe the pre-data collection systematic translation process used in a twelve country, eleven language nursing workforce survey. DESIGN AND SETTINGS: We illustrate the potential advantages of Content Validity Indexing (CVI) techniques to validate a nursing workforce survey developed for RN4CAST, a twelve country (Belgium, England, Finland, Germany, Greece, Ireland, Netherlands, Norway, Poland, Spain, Sweden, and Switzerland), eleven language (with modifications for regional dialects, including Dutch, English, Finnish, French, German, Greek, Italian, Norwegian, Polish, Spanish, and Swedish), comparative nursing workforce study in Europe. PARTICIPANTS: Expert review panels comprised of practicing nurses from twelve European countries who evaluated cross-cultural relevance, including translation, of a nursing workforce survey instrument developed by experts in the field. METHODS: The method described in this paper used Content Validity Indexing (CVI) techniques with chance correction and provides researchers with a systematic approach for standardizing language translation processes while simultaneously evaluating the cross-cultural applicability of a survey instrument in the new context. RESULTS: The cross-cultural evaluation process produced CVI scores for the instrument ranging from .61 to .95. The process successfully identified potentially problematic survey items and errors with translation. CONCLUSIONS: The translation approach described here may help researchers reduce threats to data validity and improve instrument reliability in multinational health services research studies involving comparisons acro

Contains fulltext : 97171.pdf (postprint version ) (Open Access), BACKGROUND: Current human resources planning models in nursing are unreliable and ineffective as they consider volumes, but ignore effects on quality in patient care. The project RN4CAST aims innovative forecasting methods by addressing not only volumes, but quality of nursing staff as well as quality of patient care. METHODS/DESIGN: A multi-country, multilevel cross-sectional design is used to obtain important unmeasured factors in forecasting models including how features of hospital work environments impact on nurse recruitment, retention and patient outcomes. In each of the 12 participating European countries, at least 30 general acute hospitals were sampled. Data are gathered via four data sources (nurse, patient and organizational surveys and via routinely collected hospital discharge data). All staff nurses of a random selection of medical and surgical units (at least 2 per hospital) were surveyed. The nurse survey has the purpose to measure the experiences of nurses on their job (e.g. job satisfaction, burnout) as well as to allow the creation of aggregated hospital level measures of staffing and working conditions. The patient survey is organized in a sub-sample of countries and hospitals using a one-day census approach to measure the patient experiences with medical and nursing care. In addition to conducting a patient survey, hospital discharge abstract datasets will be used to calculate additional patient outcomes like in-hospital mortality and failure-to-rescue. Via the organizational survey, information about the organizational profile (e.g. bed size, types of technology available, teaching status) is collected to control the analyses for institutional differences.This information will be linked via common identifiers and the relationships between different aspects of the nursing work environment and patient and nurse outcomes will be studied by using multilevel regression type analyses. These results will be used to simulate the impact of changing dif

The aim of the present research was to study outcomes of use of the OLD@HOME Virtual Health Record with regard to staff opinions about information, communication technology, and satisfaction with work. A quasi-experimental design was used. Staff opinions about the information and communication technology were assessed using a study-specific questionnaire at the test site (n =22) and at other settings in the municipality (n =172). Staff (n =22) job satisfaction, perceived quality of care, and psychosomatic health were assessed using the Satisfaction with Work Questionnaires before and after a 5-month period of testing the technology in an intervention and a comparison group. Staff opinions about the information and communication technology were significantly more positive at the test site compared to other settings in the municipality. For the total scale of quality of care and the factor documentation, there were significant differences in change scores between intervention and comparison groups, with improvements for the comparison group. For job satisfaction and psychosomatic health, there were no differences in change scores between the groups. Participatory design enhances staff opinions about information and communication technology. However, a 5-month test period showed no benefits regarding staff satisfaction with work when compared to a comparison group. On the contrary, the comparison group improved in documentation, and for the intervention group, there was a trend toward deterioration, which may be due to their knowing how to document, but not having time when using both paper-based and electronic systems.