The qualified presumption of safety assessment and its role in EFSA risk evaluations: 15 years past.
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ABSTRACT:
SUBMITTER: Herman L
PROVIDER: S-EPMC6962996 | biostudies-literature | 2019 Oct
REPOSITORIES: biostudies-literature
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Project description:Microorganisms are intentionally added at different stages of the food and feed chain (food or feed additive, novel food or plant protection product) and are subjected to regulation and safety assessment by the European Food Safety Authority. Safety evaluation is based on application dossiers for market authorisation to the European Commission. The qualified presumption of safety (QPS) concept was developed in 20031 to provide a harmonised generic safety pre-appraisal of the above microorganisms. Unambiguously defined biological taxonomic units (TUs) are assessed for their body of knowledge, their safety and their end use. Identified safety concerns for a certain TU can be, where reasonable in number and not universally present, reflected as 'qualifications.' Strains belonging to TUs having QPS status may benefit of a fast track evaluation. The lowest TU for which the QPS status is granted is the species level for bacteria and yeasts and the family for viruses. The QPS concept is also applicable to genetically modified microorganisms used for production purposes. Based on the current body of knowledge and/or the ambiguous taxonomic position, some TUs, such as filamentous fungi, bacteriophages, Enterococcus faecium, Escherichia coli, Streptomyces spp. and Oomycetes, are not considered liable for QPS status.
| S-EPMC6311724 | biostudies-literature
Project description: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.
| S-EPMC10331572 | biostudies-literature
Project description: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.
| S-EPMC9875162 | biostudies-literature
Project description:Background: In 2005, Network for Therapy in Rare Epilepsies (NETRE)-was initiated in order to share treatment experiences among clinicians in patients with rare epilepsies. Here we describe the structure of the rapidly growing NETRE and summarize some of the findings of the last 15 years. Methodology/Structure of NETRE: NETRE is organized in distinct groups (currently >270). Starting point is always a patient with a rare epilepsy/ epileptic disorder. This creates a new group, and next, a medical coordinator is appointed. The exchange of experiences is established using a data entry form, which the coordinator sends to colleagues. The primary aim is to exchange experiences (retrospectively, anonymously, MRI results also non-anonymously) of the epilepsy treatment as well as on clinical presentation and comorbidities NETRE is neither financed nor sponsored. Results: Some of the relevant results: (1) first description of FIRES as a new epilepsy syndrome and its further investigation, (2) in SCN2A, the assignment to gain- vs. loss-of-function mutations has a major impact on clinical decisions to use or avoid treatment with sodium channel blockers, (3) the important aspect of avoiding overtreatment in CDKL5 patients, due to loss of effects of anticonvulsants after 12 months, (4) pathognomonic MRI findings in FOXG1 patients, (5) the first description of pathognomonic chewing-induced seizures in SYNGAP1 patients, and the therapeutic effect of statins as anticonvulsant in these patients, (6) the phenomenon of another reflex epilepsy-bathing epilepsy associated with a SYN1 mutation. Of special interest is also a NETRE group following twins with genetic and/or structural epilepsies [including vanishing-twin-syndrome and twin-twin-transfusion syndrome) [= "Early Neuroimpaired Twin Entity" (ENITE)]. Discussion and Perspective: NETRE enables clinicians to quickly exchange information on therapeutic experiences in rare diseases with colleagues at an international level. For both parents and clinicians/scientist this international exchange is both reassuring and helpful. In collaboration with other groups, personalized therapeutic approaches are sought, but the present limitations of currently available therapies are also highlighted. Presently, the PATRE Project (PATient based phenotyping and evaluation of therapy for Rare Epilepsies) is commencing, in which information on therapies will be obtained directly from patients and their caregivers.
| S-EPMC7840830 | biostudies-literature
Project description:EFSA, the European Food Safety Authority, was established in 2002 as the EU's independent risk assessment body for food and feed safety. This paper takes stock of what has been achieved and what challenges lie ahead. To do so, it first reviews scientific assessments conducted by EFSA from the perspective of a scientific experiment. This includes a hypothesis that is examined by scientific experts using existing evidence and employing agreed-upon assessment methods, the results of which are made public. Next, it considers a number of characteristics legitimising this work: quality, consistency, independence and impartiality, as well as transparency and openness. Other key considerations are relevance, evolving expectations and innovations, fitness-for-purpose and efficiency, along with sustainability of the system. By and large, the scientific assessment process in place at EFSA can be understood to mimic the conduct of a scientific experiment. However, being a regulatory support mechanism, it has some distinct characteristics. Therefore, its legitimising characteristics are not necessarily identical to those used in academic research. In conclusion, since its creation 15 years ago, EFSA has very much delivered on its mission. Whatever the achievements, the EU cannot rest on its laurels though.
| S-EPMC7009995 | biostudies-literature
Project description:BACKGROUND AND OBJECTIVES: The therapy and outcome of HIV infection have dramatically changed over the last 15 years, resulting in a change in renal complications. This study analyzed the characteristics of HIV-infected patients and biopsy-proven tubulointerstitial nephropathies to define disease patterns and therapeutic implications. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A clinico-pathologic retrospective study of 59 consecutive renal biopsies showing predominant tubular and/or interstitial lesions in HIV-infected patients referred to the nephrology department between 1995 and 2011 was performed. HIV-associated nephropathy and vascular diseases were excluded from the study. RESULTS: Tubulointerstitial nephropathies accounted for 26.6% of 222 native renal biopsies performed in HIV-infected patients. Two pathologic groups were analyzed, tubulopathy and interstitial nephritis, which represented 49% and 51% of tubulointerstitial nephropathies, respectively. Most patients presented with AKI (76.3%) and high-grade proteinuria (57.7%). Drug-related nephrotoxicity was the leading cause (52.5%). Alternative etiologies included infections (15.2%), dysimmune disorders (8.5%), malignancies (3.4%), and chronic (10.2%) and acute (10.2%) tubulointerstitial nephropathies of undetermined origin. Tubulopathy was strongly associated with antiretroviral drug toxicity (75.9%) and mostly caused by tenofovir (55.2%), which was associated with proximal tubular dysfunction (87.5%), overt Fanconi's syndrome (37.5%), and nephrogenic diabetes insipidus (12.5%). Interstitial nephritis was associated with a broader spectrum of pathologic lesions and etiologies. CONCLUSIONS: In this series, tubulointerstitial nephropathies accounted for 26.6% of renal diseases in HIV-infected patients. Considering the therapeutic implications of diagnoses of drug toxicity, infection, and dysimmune syndromes, this study underscores the importance of monitoring renal parameters in HIV-infected patients and points to the relevance of kidney biopsy to allow an accurate diagnosis.
| S-EPMC3675854 | biostudies-other
Project description:It is not clear how Southern Ocean phytoplankton communities, which form the base of the marine food web and are a crucial element of the carbon cycle, respond to major environmental disturbance. Here, we use a new model ensemble reconstruction of diatom speciation and extinction rates to examine phytoplankton response to climate change in the southern high latitudes over the past 15 My. We identify five major episodes of species turnover (origination rate plus extinction rate) that were coincident with times of cooling in southern high-latitude climate, Antarctic ice sheet growth across the continental shelves, and associated seasonal sea-ice expansion across the Southern Ocean. We infer that past plankton turnover occurred when a warmer-than-present climate was terminated by a major period of glaciation that resulted in loss of open-ocean habitat south of the polar front, driving non-ice adapted diatoms to regional or global extinction. These findings suggest, therefore, that Southern Ocean phytoplankton communities tolerate "baseline" variability on glacial-interglacial timescales but are sensitive to large-scale changes in mean climate state driven by a combination of long-period variations in orbital forcing and atmospheric carbon dioxide perturbations.
| S-EPMC4922175 | biostudies-literature
Project description:PurposeOur objectives were primarily to review the published literature on complications in neuromuscular scoliosis (NMS) surgery and secondarily, by means of a meta-analysis, to determine the overall pooled rates (PR) of various complications associated with NMS surgery.MethodsPubMed and Embase databases were searched for studies reporting the outcomes and complications of NMS surgery, published from 1997 to May 2011. We focused on NMS as defined by the Scoliosis Research Society's classification. We measured the pooled estimate of the overall complication rates (PR) using a random effects meta-analytic model. This model considers both intra- and inter-study variation in calculating PR.ResultsSystematic review and meta-analysis were performed for 68 cohort and case-control studies with a total of 15,218 NMS patients. Pulmonary complications were the most reported (PR = 22.71 %) followed by implant complications (PR = 12.51 %), infections (PR = 10.91 %), neurological complications (PR = 3.01 %) and pseudoarthrosis (PR = 1.88 %). Revision, removal and extension of implant had highest PR (7.87 %) followed by malplacement of the pedicle screws (4.81 %). Rates of individual studies have moderate to high variability. The studies were heterogeneous in methodology and outcome types, which are plausible explanations for the variability; sensitivity analysis with respect to age at surgery, sample size, publication year and diagnosis could also partly explain this variability. In regard to surgical complications affiliated with various surgical techniques in NMS, the level of evidence of published literature ranges between 2+ to 2-; the subsequent recommendations are level C.ConclusionNMS patients have diverse and high complication rates after scoliosis surgery. High PRs of complications warrant more attention from the surgical community. Although the PR of all complications are affected by heterogeneity, they nevertheless provide valuable insights into the impact of methodological settings (sample size), patient characteristics (age at surgery), and continual advances in patient care on complication rates.
| S-EPMC3676557 | biostudies-literature
Project description:BackgroundPhysiological sagittal spinal curvatures play an important role in health and performance in sports. For that reason, several scientific studies have assessed spinal morphology in young athletes. However, to our knowledge, no study has assessed the implications of Inline Hockey (IH) practice on sagittal integrative spinal morphotype in adolescent players.ObjectivesThe aims of the present study were to describe habitual sagittal spinal posture in young federated IH players and its relationship with training load and to determine the sagittal integrative spinal morphotype in these players.MethodsAn observational analysis was developed to describe the sagittal spinal morphotype in young federated IH players. A total of 74 IH players from the Technification Plan organized by the Skating Federation of the Valencian Community (aged from 8 to 15 years) participated in the study. Thoracic and lumbar curvatures of the spine were measured in a relaxed standing position (SP), in a slump sitting position (SSP) and in maximum flexion of the trunk (MFT) to determine the "Sagittal Integrative Morphotype" of all players. An unilevel inclinometer was used to quantify the sagittal spinal curvatures. The Hip Joint Angle test was used to quantify the Lumbo-Horizontal angle in flexion (L-H fx) of all participants with a goniometer.ResultsWhen thoracic curvature was analyzed according to normality references, it was found that 64.9% of IH players had thoracic hyperkyphosis in a SSP, while 60.8% and 74.3% of players were classified as normal in a SP and in MFT, respectively. As for the lumbar curve, 89.2% in a SP and 55.4% in MFT were normal, whereas 68.9% of IH players presented lumbar hyperkyphosis in a SSP. Regarding the "Sagittal Integrative Morphotype," only 17.6% of players were classified as "Normal" in the three measured positions for the thoracic curve, while 37.8% had "Thoracic Hyperkyphosis" and 41.8% presented "Functional Thoracic Hyperkyphosis." As for the "Sagittal Integrative Lumbar Morphotype," only 23% of athletes had a normal curve in the three positions, whereas 66.2% presented "Functional Lumbar Hyperkyphosis." When the L-H fx was evaluated, the results showed that only 16.2% of the athletes were classified as normal.ConclusionsFederative IH practice seems to cause specific adaptations in spinal sagittal morphotype. Taking into account the "Sagittal Integrative Morphotype" only 17.6% IH players presented "Normal Morphotype" with a normal thoracic kyphosis in the three measured positions, while only 23% IH players presented "Normal Morphotype" with a normal lumbar curvature in the three assessed positions. Furthermore, only 16.2% of IH players showed normal pelvic tilt. Exercise programs to prevent or rehabilitate these imbalances in young IH players are needed.
| S-EPMC6942677 | biostudies-literature
Project description:This article presents the most important developments in the recognition process of foreign medical degrees in Costa Rica over the past fifteen years. Most applicants received their medical degrees in Cuba, Venezuela, Nicaragua and Mexico. By far the most numerous group completed their studies in Cuba, followed by graduates from Venezuelan and Nicaraguan universities, the number of which has increased in the last five years. The pass rate of the written examination used in the recognition process is 23.9% with relatively large fluctuations between graduates of the individual countries, especially between the countries with the lowest numbers of graduates. The main goal of the recognition process is to ensure that graduates from different study conditions and curricula as well as from diverging areas of specialization of the faculties abroad have competencies and knowledge comparable to those of medical graduates in Costa Rica. The focus is on the safety of the patient, as is the case with state exams in many countries.
| S-EPMC8675375 | biostudies-literature