First Evidence of Leishmania infantum Antibodies in Sheep (Ovis aries) from Southern Germany.

In Europe, Leishmania infantum is the most prevalent Leishmania species, and this protozoan is transmitted by phlebotomine sandflies. A recent publication has shown that sheep harbor L. infantum antibodies. This raises questions about the epidemiological role of small ruminants. Therefore, sera from small ruminants located in two southern German federal states, Baden-Wuerttemberg (BW) and Bavaria (BAV), were analyzed with an ELISA to determine the presence of L. infantum antibodies. The species, sex and age (gimmer vs. ewe) were recorded, and a univariate analysis was conducted to determine possible associations. In total, seven sheep flocks (274 sheep/10 goats) from BW and seven sheep flocks (277 sheep/78 goats) from BAV were examined. In BW, four sheep from three flocks tested positive for L. infantum antibodies. In BAV, the same number of positive sheep were detected but in four flocks. The total seropositivity rate in sheep was 1.45%. All goats tested negative. No significant association (p > 0.05) was detected between Leishmania seropositivity and the variables evaluated. Our study reveals the exposure of sheep to L. infantum in a non-endemic area. Further investigation is needed to determine whether sheep can be used as sentinels to identify new phlebotomine habitats and Leishmania risk areas.

Position statement of the Spanish Society of Paediatric Infectious diseases on the diagnosis and treatment of Mycoplasma pneumoniae infection.

Mycoplasma pneumoniae (M. pneumoniae) is a bacterium with particular characteristics that give rise to a broad clinical spectrum, being respiratory infection the most frequent presentation. Infection by M. pneumoniae occurs in cyclical epidemics, and paediatricians in Spain have noticed an increase in cases since January 2024, establishing hospital registers to collect surveillance data (as it is not a notifiable disease in Spain). The diagnosis of infection by M. pneumoniae is made through serological testing and/or the detection of genetic material by means of polymerase chain reaction (PCR). Neither methods can differentiate between colonization and active infection, so a precise diagnosis is not possible and testing should only be requested in the case of high clinical suspicion. The role of antibiotherapy in infection by M. pneumoniae in its different clinical variants is not well defined. Most infections are self-limiting and mild, and there is insufficient evidence to support the use of antibiotherapy in these cases. Antibiotic treatment is justified in patients with risk factors for the development of severe disease (Down syndrome, anatomical or functional asplenia, immunosuppression), in hospitalized patients with respiratory infection and in patients with moderate or severe extrapulmonary forms. Taking into account aspects concerning the rational use of antimicrobials, the treatment of choice would be clarithromycin, with azithromycin as an alternative, reserving the use of doxycycline and levofloxacin for cases of antimicrobial resistance and/or infections of the central nervous system.

Ulcerative and pyogranulomatous pododermatitis due to Pseudomonas luteola infection in a domestic ferret (Mustela putorius furo): a case report with literature review of this emerging zoonotic disease in ferrets.

Pseudomonas luteola (P.luteola), formerly called Chryseomonas luteola, is a strict aerobic gram-negative bacillus, 0.8 to 1.0 µm wide and 1.5 to 2.5 µm long, considered an opportunistic pathogen found ubiquitously in humid environments, both in soil and water. It sporadically causes disease in animals and immunosuppressed humans or those subjected to invasive procedures such us peritoneal dialysis or catheterization. In ferrets, this infection was first described in Spain in 2012 and since then, cases have appeared occasionally in Finland, Austria, Australia, France, the United States and also in Spain. This pathogen is considered an emerging zoonotic disease in ferrets, causing respiratory disease, panniculitis, and abscesses due to pyogranulomatous or suppurative inflammation predominantly of the pleura, lung, mediastinum, panniculus or salivary glands, frequently with lethal consequences. The clinical case of a ferret, infected by Pseudomona luteola, presenting with ulcerative suppurative pododermatitis and ipsilateral popliteal purulent lymphadenitis, is described. Together with a complete resolution of the clinical case by means of a non-invasive medical management likely due to the rapid detection, identification, and treatment of the infection.

Different localization of P2X4 and P2X7 receptors in native mouse lung - lack of evidence for a direct P2X4-P2X7 receptor interaction.

Introduction: P2X receptors are a family of homo- and heterotrimeric cation channels gated by extracellular ATP. The P2X4 and P2X7 subunits show overlapping expression patterns and have been involved in similar physiological processes, such as pain and inflammation as well as various immune cell functions. While formation of P2X2/P2X3 heterotrimers produces a distinct pharmacological phenotype and has been well established, functional identification of a P2X4/P2X7 heteromer has been difficult and evidence for and against a physical association has been found. Most of this evidence stems, however, from in vitro model systems. Methods: Here, we used a P2X7-EGFP BAC transgenic mouse model as well as P2X4 and P2X7 knock-out mice to re-investigate a P2X4-P2X7 interaction in mouse lung by biochemical and immunohistochemical experiments as well as quantitative expression analysis. Results: No detectable amounts of P2X4 could be co-purified from mouse lung via P2X7-EGFP. In agreement with these findings, immuno-histochemical analysis using a P2X7-specific nanobody revealed only limited overlap in the cellular and subcellular localizations of P2X4 and P2X7 in both the native lung tissue and primary cells. Comparison of P2X4 and P2X7 transcript and protein levels in the respective gene-deficient and wild type mice showed no mutual interrelation between their expression levels in whole lungs. However, a significantly reduced P2rx7 expression was found in alveolar macrophages of P2rx4 -/- mice. Discussion: In summary, our detailed analysis of the cellular and subcellular P2X4 and P2X7 localization and expression does not support a physiologically relevant direct association of P2X4 and P2X7 subunits or receptors in vivo.

Mandibular bone mass density in a medieval population and its relationship with stable isotopes δ13C and δ15N.

The aim of this study was to compare the level of bone mass in digital orthopantomograms in two populations (medieval and current) using two radiomorphometric indexes, and to correlate the mandibular bone mass value, in the medieval mandible population, with stable isotope data δ13C and δ15N. An observational, cross-sectional, and analytical study on mandibles from two diachronic groups, 15 mandibles from the medieval settlement of La Torrecilla (Granada, Spain) and 15 mandibles from current patients at the Faculty of Dentistry of the University of Granada (Spain), matched by age and sex was conducted. The bone mass density was determined using the Mandibular Cortical Width Index (MCW) and the Mandibular Panoramic Index (PMI) in digital panoramic radiographs. In the medieval group, the values of bone mass density were correlated with those of two stable isotopes (δ13C and δ15N). The mean value of MCW in mm in the medieval group was 3.96 ± 0.60 (mean ± standard deviation) and in the current group was 4.02 ± 1.01. The PMI was 0.33 ± 0.06 and 0.35 ± 0.08 in the medieval and current groups respectively, with similar results in both groups (p = 0.820 and p = 0.575). A negative correlation was found between both morphometric indices and the δ15N isotope (rs = 0.56, p = 0.030 and rs = 0.61, p = 0.016, respectively). The bone mass density in mandibles belonging to the two compared populations, determined by two quantitative radiomorphometric indices, is similar. Within the medieval population, there is an inverse correlation between the δ15N value and bone mass density.

Survey of severe acute respiratory syndrome coronavirus 2 in captive and free-ranging wildlife from Spain.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), considered a zoonotic agent of wildlife origin, can infect various animal species, including wildlife in free-range and captive environments. Detecting susceptible species and potential reservoirs is crucial for preventing the transmission, spread, genetic evolution, and further emergence of viral variants that are major threats to global health. This study aimed to detect exposure or acute infection by SARS-CoV-2 in 420 animals from 40 different wildlife species, including terrestrial and aquatic mammals, from different regions of Spain during the 2020-2023 coronavirus disease 19 (COVID-19) pandemic. In total, 8/137 animals were positive for SARS-CoV-2 antibodies against the receptor binding domain and/or viral nucleoprotein according to independent ELISAs. However, only one ELISA-positive sample of a captive bottlenose dolphin (Tursiops truncatus) tested positive for SARS-CoV-2 neutralizing antibodies with a low titre (SNT50 38.15) according to a virus neutralization test. Cetaceans are expected to have a high risk of infection with SARS-CoV-2 according to early predictive studies due to the similarity of their angiotensin converting enzyme 2 cell receptor to that of humans. Moreover, of 283 animals analysed for SARS-CoV-2 RNA using RT-qPCR, none tested positive. Our results reinforce the importance of considering cetaceans at risk for SARS-CoV-2 infection and support taking preventive biosecurity measures when interacting with them, especially in the presence of individuals with suspected or confirmed COVID-19. Although most animals in this study tested negative for acute infection or viral exposure, ongoing surveillance of wildlife species and potentially susceptible animals is important to prevent future spillover events and detect potential novel reservoirs.

Infections of cardiac implantable electronic devices and how to improve transvenous lead extraction by the virtual reality.

Introduction: Infections in cardiac implantable electronic devices (CIED) are increasing over time and associated with substantially mortality and healthcare costs. The best approach is the complete removal of the system by transvenous lead extraction (TLE). However, when leads are more than 10 years old, this technique requires considerable expertise and failures with the result of abandoned leads or serious complications may occur. The aim of this study is to describe our experience using virtual and mixed reality in the preoperative planning of complex cases. Patients and methods: Consecutive patients from a referral centre with CIED infections in which TLE was judged difficult. Synchronized computed tomography (CT) scan images were processed and transferred to a fully immersive virtual reality room and also to the operative room (mixed reality) for better guidance during the extracting procedure. Results: Ten patients (seven with local and three with systemic infections) were preoperative evaluated. Processed images and virtual reality showed intense adherences of the leads to the veins, right ventricle, and right atrium endocardium and between them that preclude a difficult extraction and required a carefully planning and sometimes a different technical approach. The anticipated difficulty was confirmed by the higher times of fluoroscopy. All leads were extracted and no complications were registered. Conclusions: Preoperative planning is essential for evaluation of TLE difficulty and prevention of unexpected situations. Virtual reality seems an estimable aid for operators in planning difficult cases and also an excellent tool for teaching. Supplementary information: The online version contains supplementary material available at 10.1007/s12055-023-01663-9.

Exploring Iberian ham triacylglycerols: Unraveling the influence of growing area, season, breed, and feeding patterns through innovative compositional data analysis.

This research examined the triacylglycerol composition of Iberian pig hams from Sevilla province, focusing on the influence of growing area, season, breed, age, montanera duration, and feeding types. Compositional data analysis (CoDA) tools and standard multivariate statistics were employed to analyse the original and CoDa-transformed data. ANOVA (ilr) and ANCOVA (log ratios) revealed significant effects of season, feeding type, and towns on triacylglycerol profiles, while montanera showed limited or no effect. Breeds and age were deemed irrelevant. Various discriminant analysis (DA) methods consistently distinguished samples from the 2004/2005 season and the cebo feeding type but struggled with other distinctions. PLS-R analysis indicated that bellota feeding was associated with triacylglycerols rich in oleic acid, while cebo was predominantly linked to those containing palmitic and stearic acids. The study challenges traditional assumptions about the effects of montanera, breeds, and age on Iberian pig hams and highlights the need for further investigation.

Standards of care and educational gaps in adult cystic fibrosis units: a European Respiratory Society survey.

Background: Significant progress in the field of cystic fibrosis (CF) has substantially extended the life expectancy of patients with CF (pwCF). Consequently, the population of adult pwCF has outnumbered paediatric patients in most developed countries. Ageing is a new factor that can contribute to disease complexity and can require adaptation of CF units. Therefore, the necessity for standardised, specialised and multidisciplinary care is imperative. Concerns arise regarding the adequacy of current healthcare, therapeutic and educational offerings. Methods: To address these concerns, a multinational survey was conducted to assess the current state of care in specialised multidisciplinary adult and paediatric CF units and identify areas for improvement. Responses were collected from 44 centres providing regular care to CF patients. Results: The survey unveiled considerable disparities in the availability of critical resources, including diagnostic access, supplementary testing, treatment modalities, transplant and transition programmes, and healthcare professionals' training. Conclusion: This study underscores the urgent need to standardise care across these centres in order to minimise disparities in terms of available resources and training with a particular emphasis on adult pwCF who are becoming more numerous and showing different needs with ageing. The changing landscape of CF in adulthood will require constant monitoring to ensure proper adaptation of the current model of care.

Effects of a Training Course for Andalusian Podiatrists on Antibiotic Management in Ingrown Toenail Infections: A Pilot Study.

BACKGROUND: The use of antibiotics (ABs) for the prevention and management of infections has been widespread for decades and, at this time, AB resistance is a global health crisis. The available evidence highlights the need to reduce the prophylactic and therapeutic use of ABs to avoid associated risks. METHODS: A preliminary study with a total sample of 56 Andalusian (Spain) podiatrists was surveyed. The purpose of this study was to identify whether there were changes in prescription habits from a situation before a subsequent training course on AB indications for the management of infections associated with ingrown toenails. An ad hoc questionnaire of 15 items related to therapeutic and prophylactic prescriptions of ABs was developed for this purpose, and the evaluation was carried out before and after the training course. RESULTS: The responses obtained before and after training were compared. The training activity led to improvements in the prescription habits of the participants, producing significant changes in the prescription pattern of the professionals in 10 of the 15 items. CONCLUSIONS: The results of this preliminary study show that the podiatrists surveyed improved the rational use of systemic AB therapy in ingrown toenails infections.

Metastatic pancreatic and lung cancer patient in complete remission following immunotherapy: A case report and review of literature.

BACKGROUND: Metastatic pancreatic ductal adenocarcinoma (PDAC) is a lethal malignancy with dispiriting survival data. Immunotherapy is a promising approach to many cancer types, but achieves poor outcomes in advanced PDAC due to its immunosuppressive tumor microenvironment. We describe a case of metastatic PDAC effectively treated with pembrolizumab. CASE SUMMARY: We report the case of a 67-year-old woman with unresectable locally advanced PDAC, treated with gemcitabine plus nab-paclitaxel followed by radiotherapy plus capecitabine. At nine months, pancreatic tumor progression was observed at the level of the hepatic hilum with the appearance of a new pulmonary nodule suggestive of a second primary, confirmed by left lung biopsy. Systemic immunotherapy was then initiated with pembrolizumab, an immune checkpoint inhibitor targeting programmed cell death protein-1 that covers the two tumor types. The patient showed a complete metabolic response that was maintained throughout the treatment. The patient continues to be disease-free at 5.6 years since the start of immunotherapy. CONCLUSION: These results suggest that the administration of pembrolizumab after chemoradiotherapy has a beneficial effect in patients with metastatic PDAC. To our knowledge, this is the first reported case of a patient with metastatic PDAC and metastatic lung cancer showing such a long-lasting complete response after pembrolizumab treatment without curative surgery. Further studies are required to determine biomarkers that identify PDAC patients most likely to benefit from this immunotherapy.

Understanding consumer food choices & promotion of healthy and sustainable Mediterranean diet and lifestyle in children and adolescents through behavioural change actions: the DELICIOUS project.

Over the last decades, the abandonment of traditional dietary patterns, such as the Mediterranean diet, represents an important threat for human health and environmental safeguard. The DELICIOUS project aims to promote healthy lifestyles among children and adolescents by implementing activities and tools to increase the adherence to the Mediterranean Diet with an attention to the environmental impacts of the diet. This study protocol describes the DELICIOUS project as a single-arm, uncontrolled behavioural intervention providing formal and non-formal education activities, development of new snacks and recipe reformulation, web/mobile app development, and physical activities to school children and adolescents in five European countries. The project aims to increase awareness of the nutritional benefits and the sustainability aspects of the Mediterranean Diet and to promote consumers' empowerment through an online platform for sustainable and healthy meal planning in the school canteen.

Detection and comparison of neutrophil extracellular traps in tissue samples of peri-implantitis, periodontitis, and healthy patients: A pilot study.

OBJECTIVE: The aim of this study was to detect and compare the tissular expression of neutrophil extracellular traps (NETs) in peri-implant and periodontal samples of patients with peri-implantitis, periodontitis, and controls. MATERIALS AND METHODS: An observational study was performed on patients with peri-implantitis, periodontitis, and controls. Peri-implant and/or periodontal clinical examinations were performed on each participant. Tissue samples were collected during tooth/implant extraction for clinical reasons. Electron microscopy analysis, Picro-Sirius red staining, immunohistochemical (CD15), and immunofluorescence (citrullinated H3 and myeloperoxidase) techniques were performed to detect NET-related structures and the degree of connective tissue destruction, between the study groups. RESULTS: Sixty-four patients were included in the study: 28 peri-implantitis, 26 periodontitis, and 10 controls, with a total of 51 implants, 26 periodontal teeth, and 10 control teeth. Neutrophil release of nuclear content was observed in transmission electron microscopy. Immunohistochemical analysis showed a greater CD15 expression in both peri-implantitis and periodontitis compared to controls (p < 0.001), and peri-implantitis presented lower levels of connective tissue and collagen compared to both periodontitis (p = 0.044; p < 0.001) and controls (p < 0.001). Immunofluorescence showed greater citH3 expression in peri-implantitis than the one found in both periodontitis (p = 0.003) and controls (p = 0.048). CONCLUSIONS: A greater presence and involvement of neutrophils, as well as a greater connective tissue destruction were observed in cases of peri-implantitis. A higher expression of NET-related markers was found in mucosal samples of peri-implantitis compared to periodontitis and controls.

Case Report: Ambergris coprolite and septicemia in a male sperm whale stranded in La Palma (Canary Islands).

On the 21st of May 2023, a dead adult male sperm whale (Physeter macrocephalus) of 13 m in length and estimated weight of around 18,000 kg was reportedly stranded at Playa Los Nogales, La Palma, Canary Islands, Spain. A necropsy was performed 48hpm. A 50 cm diameter and 9.5 kg coprolite was found obstructing the caudal colon-rectal lumen. Necro-hemorrhagic lesions were found in heart muscles and three different bacteria of intestinal origin were isolated and identified (Edwarsiella tarda, Hathewaya limosa and Clostridium perfringens). It is reported a lethal septicemia of intestinal origin associated with ambergris coprolite as cause of death in this sperm whale.

A case report of acute claudication due to vena cava thromboembolism in a dog naturally infected with Leishmania Infantum.

Canine leishmaniosis is a vector-borne disease caused by Leishmania infantum, and clinical manifestations of infection range from absent or severe to fatal and result from immune-mediated mechanisms. In dogs, the most common clinical signs of leishmaniosis include skin lesions and lymphadenomegaly. However, the presence of other nontypical signs has been described, and diagnosing these cases can be challenging. The aim of the present short communication was to describe the impact of the formation of circulating immunocomplexes due to L. infantum in a dog with leishmaniosis affected by a massive venous thrombus of the caudal vena cava and external iliac veins. On admission, the dog presented bilateral cutaneous vasculopathy of the thigh and renal disease due to L. infantum infection. Two weeks after starting anti-Leishmania treatment based on meglumine antimoniate and allopurinol administration, the animal developed acute claudication of the hind limbs with the presence of a thrombus in the caudal vena cava and the external iliac veins and a high level of circulating immunocomplexes detected by enzyme-linked immunosorbent assay. Exacerbation of the humoral immune response, along with deposition of circulating immune complexes in the tissues and the concurrent presence of kidney and liver damage, might have contributed to an imbalance in haemostasis in this patient. Future studies should evaluate and analyse the pathological mechanisms contributing to thrombosis in dogs with leishmaniosis.

Shipwrecked on the Rock, or Not Quite: Gypsophytes and Edaphic Islands.

Species-area relationships (SAR) constitute a key aspect of ecological theory and are integral to other scientific disciplines, such as biogeography, which have played a crucial role in advancing biology. The theory of insular biogeography provides a clear example. This theory initially expanded from true islands to other types of systems characterized by their insularity. One such approach was linked to geoedaphic islands, as seen in gypsum outcrops. While these continental areas have been considered insular systems, only limited and mostly indirect evidence thereof has been provided. This study utilized SAR to advance the understanding of gypsum outcrops as insular continental territories. It is hereby hypothesized that gypsum outcrops are edaphic islands, although their insular nature depends on the different functional or ecological plant types, and this nature will be reflected in the potential Arrhenius model z values. The results obtained support both hypotheses and provide insight into the ecological factors that help interpret the insularity of these areas. This interpretation goes beyond their mere extent and the distance among outcrops, emphasizing the importance of environmental filters. Said filters vary in permeability depending on the degree of gypsophily, or preference for gypsum, exhibited by different species.

Recommendations for the management of yttrium-90 radioembolization in the treatment of patients with colorectal cancer liver metastases: a multidisciplinary review / Recomendaciones para el manejo de la radioembolización con itrio-90 en el tratamiento de pacientes con metástasis hepáticas de cáncer colorrectal: una revisión multidisciplinaria

Purpose: Strategies for the treatment of liver metastases from colon cancer (lmCRC) are constantly evolving. Radioembolization with yttrium 90 (Y-90 TARE) has made significant advancements in treating liver tumors and is now considered a potential option allowing for future resection. This study reviewed the scientific evidence and developed recommendations for using Y-90 TARE as a treatment strategy for patients with unresectable lmCRC. Methods: A multidisciplinary scientific committee, consisting of experts in medical oncology, hepatobiliary surgery, radiology, and nuclear medicine, all with extensive experience in treating patients with ImCRC with Y-90 TARE, led this project. The committee established the criteria for conducting a comprehensive literature review on Y-90 TARE in the treatment of lmCRC. The data extraction process involved addressing initial preliminary inquiries, which were consolidated into a final set of questions. Results: This review offers recommendations for treating patients with lmCRC using Y-90 TARE, addressing four areas covering ten common questions: 1) General issues (multidisciplinary tumor committee, indications for treatment, contraindications); 2) Previous process (predictive biomarkers for patient selection, preintervention tests, published evidence); 3) Procedure (standard procedure); and 4) Post-intervention follow-up (potential toxicity and its management, parameters for evaluation, quality of life). Conclusions: Based on the insights of the multidisciplinary committee, this document offers a comprehensive overview of the technical aspects involved in the management of Y-90 TARE. It synthesizes recommendations for applying Y-90 TARE across various phases of the treatment process.(AU)

Body composition and risk for sarcopenia in transgender women.

OBJECTIVES: Body composition and strength of cisgender (cis) individuals are well established. However, those for transgender women (trans women) undergoing gender-affirming hormone therapy remain unclear. This study aimed to detect possible body composition and strength variations related to sarcopenia. METHODS: This was a cross-sectional comparative study of 37 trans women, 34 cis men, and 34 cis women. Body composition was measured in all individuals by bioelectrical impedance analysis; prehensile strength by dynamometry was studied in trans women. RESULTS: In this study, trans women had higher body mass index values than cis individuals (P < 0.01). Fat mass was 41% higher for trans women than cis men. Muscle mass (MM) was lower in trans women than cis men (-10%), and higher than cis women (24%). Bone mass was lower in trans women than cis men and higher in cis women (P < 0.01). Trans women's prehensile strengths were 25.26 kg for the right hand and 24.8 kg for the left. Appendicular skeletal muscle mass was 23.63 kg, and appendicular skeletal muscle mass index was 8.14 kg. CONCLUSION: Trans women undergoing gender-affirming hormone therapy show a tendency to adapt body compartments to those of cis women with increased fat mass and reduced muscle mass. Prehensile strength in trans women was close to the cutoff points for sarcopenia risk. Nutrition, physical activity, strength, and body composition are important to avoid the possible risk for sarcopenia. More studies along these lines are necessary, especially in older adults.

Age and sex differences in pharmaceutical contamination in a keystone scavenger.

Pharmaceutical contaminants have a recognized negative impact on wildlife health. However, there are still many knowledge gaps on the factors influencing exposure and metabolic processing of compound mixtures as a function of season and individual characteristics such as age and sex. We evaluated age and sex differences in a set of seventeen compounds, including eleven antibiotics, five NSAIDs and caffeine, evaluated by HPLC-MS-TOF analysis in griffon vultures (Gyps fulvus) from central Spain. Pharmaceutical cocktails (up to 10 compounds simultaneously) were found in all individuals. Lincomycin was detected in all individuals, and fluoroquinolones were found at high frequencies, while NSAIDs were at low frequencies and concentrations, including flumixin meglumine, which can be lethal to vultures. A higher total number of compounds and sum of concentrations, as well as prevalence and concentration of several of the pharmaceuticals tested was found in females than in males for both nestlings and adults. This is the first study to present evidence of sex differences in the pharmacokinetics of dietary drug contaminants in a vulture species. Chronic exposure to "medications" in entire populations can potentially have sub-lethal health effects that affect fitness differently according to age and sex, with demographic implications for population viability. Specifically, if females have higher mortality after fledging due to high pharmaceutical contamination, this should be considered when modelling the population dynamic of this species for conservation purposes.

Assessment of genetically modified maize DP202216 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-159).

Genetically modified maize DP202216 was developed to confer tolerance to glufosinate-ammonium-containing herbicides and to provide an opportunity for yield enhancement under field conditions. These properties were achieved by introducing the mo-pat and zmm28 expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP202216 and its comparator needs further assessment, except for the levels of stearic acid (C18:0), which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the PAT and ZMM28 proteins as expressed in maize DP202216, and finds no evidence that the genetic modification would change the overall allergenicity of maize DP202216. In the context of this application, the consumption of food and feed from maize DP202216 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP202216 is as safe as the comparator and non-GM reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP202216 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP202216. The GMO Panel concludes that maize DP202216 is as safe as its comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.