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In European regulations for the deliberate release into the environment of genetically modified organisms (GMO), the objective of General Surveillance in Post-Market Environmental Monitoring is defined as the identification of the occurrence of adverse effects of the GMO or its use which were not anticipated in the environmental risk assessment (ERA). Accompanying the commercial cultivation in the EU of maize event MON 810, General Surveillance was implemented by Monsanto, the authorization holder, on a voluntary basis. We carried out a statistical analysis on the pooled results of ten years of farmer questionnaires, which were a part of this General Surveillance, amounting to 2,627 farmer fields in eight European countries in the period 2006-2015. This analysis did not reveal any unexpected adverse effects associated with the cultivation of MON 810. Results from farmer questionnaires confirmed that the cultivation of MON 810 resulted in a significant reduction in the use of pesticides, efficient protection against the target pests, and healthier, higher yielding crops compared to conventional maize. MON 810 also had reduced susceptibility to disease and pests when compared to conventional maize. Monitoring characteristics related to environment and wildlife revealed no significant differences between MON 810 and conventional maize. Literature searches, that were also conducted as part of General Surveillance, identified a comprehensive set of publications addressing environmental safety as well as food and feed safety aspects of MON 810. None of the publications indicated any adverse effect of MON 810 that was not anticipated in the initial ERA, nor did they lead to a change in the conclusions of the initial risk assessment that demonstrated the safety of MON 810. The development of resistance by the target pests (Ostrinia nubilalis, ECB and Sesamia nonagrioides, MCB) was the only potential adverse effect identified in the ERA of MON 810 cultivation in the EU. The extensive safety data package for MON 810, the robust weight of evidence demonstrating both its safety and benefits, and the history of safe use of MON 810 for 15 years in the EU, indicates that focussing the General Surveillance of MON 810 on literature searches and farmer complaint systems would be appropriately protective. This will allow the identification of potential adverse effect not anticipated in the initial ERA without the intensive effort and organizational challenges of farmer questionnaires., Competing Interests: This work was part of the regulatory programs of Monsanto Company*. All of the authors were employees of Monsanto [IB, RFC, GH, CN and LB] or BioMath [KS and JS] while engaged in the research project described in this publication. This does not alter our adherence to PLOS ONE policies on sharing data and materials. * Note that Monsanto has become a subsidiary of Bayer AG as of 21 August 2018. However, as the monitoring tasks described in this manuscript were conducted before the specified date, the name ‘Monsanto’ is kept throughout the documents.

Herbicides are the most effective tools for controlling almost 99% of weeds. However, herbicide resistance is a primary concern in modern agriculture. The characterization in new areas and elucidation of the mechanisms of resistance are of vital importance in maintaining the sustainability of herbicides, including glyphosate. Nine populations of Lolium rigidum, showing different response patterns, were characterized as being glyphosate resistant (GR). The wide range of values in fresh weight reduction, survival, shikimic acid and EPSPS enzyme activity indicates a different or a combination resistance mechanism. The Line-3 population resulted in minimum reduction of fresh weight and survival values with respect to the glyphosate-susceptible (GS) population, showing 16.05- and 17.90-fold higher values, respectively. There were significant differences in the 14 C-glyphosate translocation between GR and GS populations. Moreover, there were differences among the nine GR populations, but they exhibited a reduction in the remaining glyphosate translocation in the treated leaf. The EPSPS gene sequence revealed a Pro-106-Ser substitution in four populations, which could be characterized as being GR with non-target-site and target-site resistance mechanisms. This complexity of several resistance mechanisms makes it necessary to develop long-term integrated weed management strategies to limit further resistance dispersal.

The resistance mechanism of a glyphosate-resistant Lolium multiflorum Lam. biotype collected in Córdoba (Southern Spain) was examined. Resistance Factor values at three different growth stages ranged between 4.77 and 4.91. At 96 hours after treatment (HAT) the S biotype had accumulated seven times more shikimic acid than the R biotype. There were significant differences in translocation of (14)C-glyphosate between biotypes, i.e. at 96 HAT, the R biotype accumulated in the treated leaf more than 70% of the absorbed herbicide, in comparison with 59.21% of the S biotype; the R biotype translocated only 14.79% of the absorbed (14)C-glyphosate to roots, while in the S population this value was 24.79%. Visualization of (14)C-glyphosate by phosphor imaging showed a reduced distribution in the R biotype compared with the S. Glyphosate metabolism was not involved in the resistance mechanism due to both biotypes showing similar values of glyphosate at 96 HAT. Comparison of the EPSPS gene sequences between biotypes indicated that the R biotype has a proline 182 to serine amino acid substitution. In short, the resistance mechanism of the L. multiflorum Lam. biotype is due to an impaired translocation of the herbicide and an altered target site., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Objectives: The purpose of this study was to evaluate endothelial function after post-dilation of bare-metal stents with paclitaxel-coated balloons (PCB) or non-drug-coated balloons (non-DCB) in a porcine model., Background: DCB are an attractive alternative to drug-eluting stents because they provide short duration of drug exposure, while potentially inhibiting in-stent restenosis. Drug-eluting stents are associated with impaired endothelial function. It is unknown whether this abnormal vasomotor function is mitigated by reduced duration of drug exposure., Methods: Thirteen pigs underwent bare-metal stent implantation (arteries, n = 30), followed by post-dilation with either PCB (SeQuent Please, B. Braun Melsungen AG, Berlin, Germany) (n = 17) or non-DCB (n = 13). Five pigs with unstented arteries (n = 14) were controls. Coronary vasomotion was assessed 1 month after stent implantation, using acetylcholine (Ach) and nitroglycerin. Measurements were obtained for distal segments., Results: Angiographic late loss and histological area stenosis were similar between PCB and non-DCB. However, the percentage of diameter change in response to Ach was diminished with PCB (p < 0.05), when compared with either non-DCB or naive arteries. There was no difference between non-DCB and naive arteries. Inflammatory score and intramural fibrin grading were significantly greater in PCB than non-DCB (p < 0.05). Additionally, inflammatory cell infiltration in the stented segments correlated with the degree of percentage of diameter change in response to Ach, at distal regions., Conclusions: Post-dilation of bare-metal stents with PCB was associated with impaired vasodilatory response to Ach distal to the treated segments. Vasodilatory response after post-dilation with non-DCB was similar to control arteries., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)