Genetically modified (GM) maize MON 94804 was developed to achieve a reduction in plant height by introducing the GA20ox_SUP suppression cassette. The molecular characterisation and bioinformatic ...analyses do not identify issues requiring food/feed safety assessment. None of the agronomic/phenotypic and compositional differences identified between maize MON 94804 and its conventional counterpart needs further assessment, except for ear height, plant height and levels of carbohydrates in forage, which do not raise safety or nutritional concerns. The Panel on Genetically Modified Organisms (GMO Panel) does not identify safety concerns regarding the toxicity and allergenicity of the GA20ox_SUP precursor‐miRNA and derived mature miRNA as expressed in maize MON 94804 and finds no evidence that the genetic modification would change the overall allergenicity of maize MON 94804. In the context of this application, the consumption of food and feed from maize MON 94804 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 94804 is as safe as the conventional counterpart and non‐GM maize varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 94804 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 MON 94804. The GMO Panel concludes that maize MON 94804 is as safe as its conventional counterpart and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment.
Genetically modified maize MON 87419 was developed to confer tolerance to dicamba‐ and glufosinate‐based herbicides. These properties were achieved by introducing the dmo and pat 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 MON 87419 and its conventional counterpart needed further assessment, except for the levels of arginine and protein in grains which did not raise safety and nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the dicamba mono‐oxygenase (DMO) and phosphinothricin N‐acetyltransferase (PAT) proteins as expressed in maize MON 87419. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize MON 87419. In the context of this application, the consumption of food and feed from maize MON 87419 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 87419 is as safe as the conventional counterpart and non‐GM maize varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87419 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 MON 87419. The GMO Panel concludes that maize MON 87419 is as safe as its conventional counterpart and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment.
Genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 was developed by crossing to combine five single events: MON 89034, 1507, MIR162, NK603 and DAS‐40278‐9. The GMO ...Panel previously assessed the five single maize events and 16 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations were identified that could lead to the modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the five‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that five‐event stack maize, as described in this application, is as safe as the non‐GM comparator and non‐GM maize varieties tested. In the case of accidental release of viable five‐event stack maize grains into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in nine of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the five‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the five‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment.
Buerger's disease or thrombangiitis obliterans (TAO) is non artherosclerotic vascular disease that most commonly affects the small and medium-sized peripheral arteries and veins. Although a strong ...association with tobacco use has been established, the cause of the disease remains unknown. Possible pathogenic factors include autoimmune phenomena, haemostatic factors abnormalities and hyperhomocystynemia, however their role still remains controversial. In this study we investigated the role of blood coagulation and fibrinolytic factors abnormalities in the development of TAO. We assessed plasma activity of factor VII (FVII) factor VIII (FVIII), factor IX (FIX), plasminogen (PLG), urokinase type plasminogen activator (uPA) and its receptor (uPAR), uPA complex with plasminogen activator inhibitor 1 (uPA-PAI-1), anexin V, apolipoprotein A (ApoA), homocysteine, folic acid and serum lipids profile. Blood samples were collected from 37 patients with TAO (8 female and 29 male) with median age 39.5 years (ranging from 20 to 50 years). In patients with Buerger's disease there were significantly higher levels of prothrombotic factors as compared to healthy control: anexin V (8.27±6.28 ng/ml vs 2.93±2.06 ng/ml, p=0.0003), FIX (109.72±30.05% vs 78.54±12.28%, p=0.000003), FVII (123.28±30.10% vs 104.36±43.38%, p=0.0001), FVIII (119.85±44.39% vs 60.19±20.77%, p=0.0000001), homocysteine (11.53±2.88 μmol/l vs 9.86±2.20 μmol/l, p=0.01) and fibrinogen (5.06±1.94mg/dL vs 3.31±1.03mg/dL, p=0.00007). Mean uPA, uPAR and uPA/PAI-1 complex plasma levels were also higher in patients with Buerger's disease than in healthy control: 1067.07±264.97pg/mL vs 979.01±170.93pg/mL, p=0.0008; 1798.22±438.43pg/mL vs 1348.20±194.95pg/mL, p=0.000004; 303.60±288.16pg/mL vs 110.17±166.71pg/mL, p=0.000006, respectively. In contrast, plasma concentrations of ApoA and folic acid were significantly lower in patients with TAO compared to healthy control: 135.30±18.77pg/dL vs 156.46±19.97pg/dL, p=0.004 and 4.82±2.35mg/dL vs 6.84±2.70mg/dL, p=0.0006; res. Moreover there was a significant correlation between prothrombotic factors plasma levels: FIX and plasminogen (R=0.44) as well as between FVII and uPA-PAI complex (R=0.52). We found significant differences concerning studied parameters between smoking and non-smoking patients with TAO: i.e. significantly higher level of PLG (120.66±14.33pg/mL vs 108.07±17.97pg/mL, p=0.03), total cholesterol (198.36±43.95mg/dL vs 178.64±44.93mg/dL, p=0.001) and triglycerides (161.36±117.47mg/dL vs 103.50±63.20mg/dL, p=0.04), as well as lower plasma levels of folic acid (4.43±2.31mg/dL vs 5.59±2.39mg/dL, p=0.02) in smokers group. Coffee use correlated only with increased homocysteine plasma level (12.31±2.70 vs 9.96±2.68, p=0.04). In 72.2% of TAO patients, surgery was required due to aggressive disease. In this group, we found higher level of plasminogen (119.78±15.34pg/mL vs 105.12±16.35pg/mL, p= 0.04), FVII (128.50±28.90% vs 109.70±30.70%, p=0.03), total lipids (692.49±186,33mg/dL vs 514.00±96.30mg/dL, p=0,002), cholesterol 201.73±42.63mg/dL vs 162.00±38.46mg/dL, p=0.02) and triglycerides (163.62±110.70mg/dL vs 74.50±27.09mg/dL, p=0.001) as compared to the patients treated only conservatively. Our results indicate an important role of hemostatic risk factors in pathogenesis of Buerger's disease with special regard to increased plasma concentration of homocysteine that was proved to cause lesions of blood vessels endothelium. Decreased serum level of folic acid that was found in TAO patients may contribute to hyperhomocysteinemia. Patients with aggressive clinical course of TAO, requiring surgical treatment had more disturbances in serum lipids. These findings suggest that diet supplementation of folic acid as well as normalization of lipids balance might influence clinical course of TAO.
