Monsanto Europe Research Articles

Disharmonization in the Regulation of Transgenic Plants in Europe

Disharmonization in the Regulation of Transgenic Plants in Europe

Assessment of genetically modified soybean MON89788 forrenewal of authorisation under Regulation (EC) No1829/2003 (application EFSA-GMO-RX-011).

Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in soybean MON 89788 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐011 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 89788.

Annual post-market environmental monitoring report on the cultivation of genetically modified maize MON810 in 2016.

Following a request from the European Commission, EFSA assessed the annual post‐market environmental monitoring (PMEM) report for the 2016 growing season of the Cry1Ab‐expressing maize event MON 810 provided by Monsanto Europe S.A. Partial compliance with refuge requirements was reported in Spain, as observed in previous years. EFSA reiterates the need to achieve full compliance in areas of high maize MON 810 adoption to delay resistance evolution, and therefore advocates increasing the level of compliance in such areas. Resistance monitoring data do not indicate a decrease in susceptibility to the Cry1Ab protein in the field corn borer populations tested in the 2016 season. However, EFSA identified some methodological and reporting limitations pertaining to resistance monitoring that need improvement in future PMEM reports. No complaints related to corn borer infestation of maize MON 810 were received via the farmer alert system during the 2016 cultivation season. EFSA encourages the consent holder to provide more information on this complementary resistance monitoring tool. The data on general surveillance do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. EFSA reiterates its recommendations on the methodology and analysis of farmer questionnaires, and considers that future literature searches on maize MON 810 performed in the context of annual PMEM reports should follow the guidelines given in the 2017 EFSA explanatory note on literature searching. Moreover, EFSA encourages relevant stakeholders to implement a methodological framework that enables the use of existing networks in the broader context of environmental monitoring. EFSA concludes that no new evidence has been reported in the 2016 PMEM report that would invalidate previous EFSA evaluations on the safety of maize MON 810.

Organic Matter Composition More Important than Concentration in Ion Exchange Demineralization of Different Water Qualities for the Production of Steam

Fresh water becomes a limited resource in the industry. In order to help chemical industries use other water sources and close their water cycle for the production of steam, a well-founded insight on the challenges and possibilities of switching from one specific water quality to another is needed. A case study for Monsanto Europe N.V. was carried out, but the main findings hold for many more applications, as many industries struggle with water scarcity and feel the need to reuse wastewater. Besides demineralization by ion exchange (IEX), the total organic carbon (TOC) concentration, composition, and the formation of organic acids under boiler conditions were investigated for two different water qualities (Antwerp tap water and wastewater after reverse osmosis (RO) treatment). The comparison included the effect of TOC composition on its removal by IEX and the potential corrosiveness of TOC compounds. Despite tap water showing a more efficient and higher TOC removal compared to RO permeate (93% and 57%, respectively), tap water led to more organic acid formation under boiler conditions. Including the composition of the organic matter in TOC corrosiveness assessment may offer multiple advantages, not in the least economic benefits, when less treatment is required in order to meet the TOC limit value.

Split application of glyphosate in herbicide-tolerant maize provides efficient weed control and favors beneficial epigeic arthropods

Wide deployment of genetically modified herbicide-tolerant (GMHT) maize may affect the efficiency of weed control methods and impair ecosystem functioning. We examined these potential threats using glyphosate-tolerant maize NK603 (Monsanto Technology LLC, St. Louis, MO, USA) planted in 54 randomly distributed plots in 2013 and 2014. Maize was grown in three herbicide treatments combined with six tillage regimes. Conventional, single post-emergence application of a selective herbicide MaisTer (Bayer CropScience GmbH, Frankfurt am Main, Germany; hereafter as MT) was compared with two herbicide strategies used in the glyphosate-tolerant crops: split application of Roundup Rapid (Monsanto Europe S.A./N.V., Brussels, Belgium; hereafter as RRRR) and application of this herbicide mixed with the soil residual herbicide Guardian Extra (Monsanto Europe S.A./N.V.; hereafter as RRGE). MT proved unreliable, whereas RRRR and especially RRGE provided efficient weed control and affected weed performance during the season. RRRR permitted restoration of weed cover during the latter half of the cultivation season. Conventional, reduced, and conservation (mulching with Hordeum vulgare, Phacelia tanacetifolia, Sinapis alba, and Trifolium incarnatum) tillage had minor effect on the weed performance. Carabids, staphylinids, and spiders were monitored to assess environmental impact of tested weed management practices. Carabid communities were not affected by the type of tillage but responded to the herbicide treatments. The plots treated with MT harbored the highest carabid activity abundance and species richness, followed by RRRR, and then by RRGE. RRRR and RRGE treatments also reduced the rise of staphylinid abundance and species richness after harvest, while conventional tillage negatively affected staphylinids at the start of the cultivation season. Spider and carabid activity abundance was similar, but spider species richness was highest in the RRRR plots. Neither herbicides nor tillage strongly affected arthropod species evenness. Multivariate analysis showed that weed species richness was significantly correlated with the species activity abundance of all three arthropod groups; weed coverage had a similar but smaller effect but the effect of herbicides and tillage was negligible. We concluded that herbicide treatments curbed weed performance which consequently influenced associated arthropods.The RRRR herbicide treatment adequately regulates weeds and exerts restoration of weed cover later in growing season that is beneficial to the arthropods. Thus, GMHT crops have a potential to combine economic and environmental advantages for agroecosystem sustainability and can be recommended for implementation in European crop production systems.

Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2015 from Monsanto Europe S.A.

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) assessed the annual post‐market environmental monitoring (PMEM) report for the 2015 growing season of the Cry1Ab‐expressing maize event MON 810 provided by Monsanto Europe S.A. The GMO Panel concludes that the insect resistance monitoring data submitted to EFSA do not indicate a decrease in susceptibility of field Iberian populations of corn borers to the Cry1Ab protein during the 2015 season. However, since the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the GMO Panel reiterates its previous recommendations on resistance monitoring to provide sufficient detection sensitivity. Although the farmer alert system to report complaints about product performance could complement the information obtained from the laboratory bioassays, the GMO Panel is currently not in a position to appraise its usefulness, and therefore encourages the consent holder to provide more information on this complementary resistance monitoring tool. The data on general surveillance (GS) do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. The GMO Panel reiterates its previous recommendations on the analysis of farmer questionnaires, and advises the consent holder to provide more detailed information on the conducting and reporting of the literature search in future annual PMEM reports. Moreover, the GMO Panel encourages relevant parties to continue developing a methodological framework to use existing networks in the broader context of environmental monitoring. The GMO Panel concludes that the case‐specific monitoring (CSM) and GS activities of maize MON 810 as carried out by the consent holder do not provide evidence that would invalidate previous GMO Panel evaluations on the safety of maize MON 810.

Outcome of a public consultation on the draft Guidance to develop specific protection goals options for environmental risk assessment at EFSA, in relation to biodiversity and ecosystem services

Outcome of a public consultation on the draft Guidance to develop specific protection goals options for environmental risk assessment at EFSA, in relation to biodiversity and ecosystem services

Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2014 from Monsanto Europe S.A.

Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2014 from Monsanto Europe S.A.

Revised annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2013 from Monsanto Europe S.A

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the results of the general surveillance activities contained in the revised annual post-market environmental monitoring (PMEM) report for the 2013 growing season of maize MON 810 provided by Monsanto Europe S.A. The supplied data do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810 cultivation in 2013. Similar methodological shortcomings to those observed in previous annual PMEM reports were identified in the analysis of farmer questionnaires and the conduct of the literature review. The EFSA GMO Panel therefore strongly reiterates its previous recommendations to improve the methodology of future annual PMEM reports on maize MON 810. The EFSA GMO Panel urges the applicant to consider how to make best use of the information recorded in national registers in order to optimise sampling for farmer questionnaires, reiterates its previous recommendations on insect resistance monitoring and continued screening, and requests to continue reviewing and discussing relevant scientific publications on possible adverse effects of maize MON 810 on rove beetles. Also, the EFSA GMO Panel encourages relevant parties to continue developing a methodological framework to use existing networks in the broader context of environmental monitoring.

Relevance of a new scientific publication (Trtikova et al., 2015) on previous EFSA GMO Panel conclusions on the risk assessment of maize MON 810 and other Cry1Ab‐expressing Bt‐maize events

Relevance of a new scientific publication (Trtikova et al., 2015) on previous EFSA GMO Panel conclusions on the risk assessment of maize MON 810 and other Cry1Ab‐expressing Bt‐maize events

Scientific Opinion on the annual post-market environmental monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2013

Scientific Opinion on the annual post-market environmental monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2013

Scientific Opinion on the annual post-market environmental monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2012

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the post-market environmental monitoring (PMEM) report for the 2012 growing season of maize MON 810 provided by Monsanto Europe S.A. The EFSA GMO Panel noted that the applicant used a similar methodology as the one previously established for monitoring maize MON 810 in 2009, 2010 and 2011. The EFSA GMO Panel therefore focused its assessment on the novel datasets specific to the 2012 growing season of maize MON 810, and not on the methodology. The data submitted by the applicant in its 2012 PMEM report do not indicate any adverse effects on human and animal health or the environment arising from maize MON 810 cultivation in 2012. However, having already highlighted the poor sensitivity of the methodology followed by the applicant, the EFSA GMO Panel strongly reiterates its previous recommendations for the improvement of the methodology. In addition, the EFSA GMO Panel recommends that the applicant: (1) further investigates effects observed during the monitoring of baseline susceptibility of target pests in Spain; (2) follow-up possible adverse effects of maize MON 810 on rove beetles.

Scientific Opinion on the annual post‐market environmental monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2012

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the post-market environmental monitoring (PMEM) report for the 2012 growing season of maize MON 810 provided by Monsanto Europe S.A. The EFSA GMO Panel noted that the applicant used a similar methodology as the one previously established for monitoring maize MON 810 in 2009, 2010 and 2011. The EFSA GMO Panel therefore focused its assessment on the novel datasets specific to the 2012 growing season of maize MON 810, and not on the methodology. The data submitted by the applicant in its 2012 PMEM report do not indicate any adverse effects on human and animal health or the environment arising from maize MON 810 cultivation in 2012. However, having already highlighted the poor sensitivity of the methodology followed by the applicant, the EFSA GMO Panel strongly reiterates its previous recommendations for the improvement of the methodology. In addition, the EFSA GMO Panel recommends that the applicant: (1) further investigates effects observed during the monitoring of baseline susceptibility of target pests in Spain; (2) follow-up possible adverse effects of maize MON 810 on rove beetles.

Scientific Opinion on the annual Post‐Market Environmental Monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2011

Scientific Opinion on the annual Post‐Market Environmental Monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2011

Scientific Opinion on the annual Post-Market Environmental Monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2010

Scientific Opinion on the annual Post-Market Environmental Monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2010

Scientific Opinion on the annual Post-Market Environmental Monitoring(PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON810 in 2009

Scientific Opinion on the annual Post-Market Environmental Monitoring(PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON810 in 2009

MODELING OF THE FOULING PROBABILITY OF AN ACTIVATED SLUDGE DRYER

Better understanding (and so better control) of the stickiness phenomenon of drying sludge is critical for proper operation of a variety of industrial dryers, as is the case for the combined centrifuge-dryer system used on the Monsanto Europe site in Antwerp, Belgium. In this paper a binary logistic regression analysis is performed on a 4-years data base, which resulted in an empirical model for the evaluation of the dryer fouling probability as function of changes in the Sludge Volume Index (SVI) and the dosing of clay additive and tertiary (flotation) sludge to the main secondary (biological) sludge feed to the system. According to the research results, a decreasing SVI increases the probability of obtaining fouling in the dryer. Furthermore, in periods of low SVI, the fouling probability can be reduced significantly by reducing the clay dosing. This extended analysis confirms the hypothesis formulated earlier (Peeters et al., 2009a) that a wetter cake (induced by high SVI and low clay dosing) at the beginning of the drying stage of this system is better to avoid drying sludge fouling the dryer wall. Copyright © 2010 IFAC

A Strong Case for Transparency: Public Interest in Disclosure of Risk Data P revails over Business Secrets

AbstractIn a dispute between Greenpeace Germany and Monsanto Europe concerning the confidentiality of its controversial rat feeding study the Higher Administrative Court of the federal State North Rhine-Westphalia (OVG Münster) refused to grant Monsanto an injunction to stop the German authorities from releasing the requested data to Greenpeace.' The decision has acknowledged the public's right to know and strengthened the principles of transparency and participation. On the grounds of a modern approach to risk policy and to genetically modified organisms (GMO), which the Court held to be enshrined in Article 25(4) of Directive 2001/18/EC, the Court has attributed the right to information priority over conflicting commercial interests. As far as risk data is concerned the Court stressed that European Law requires a maximum degree of transparency as an indispensable condition for the introduction of GM plants within Community territory. Furthermore, the decision recognised that in the field of genetic engineering law the right of companies to invoke operating or business secrets to justify exceptions to the right of access is narrowly circumscribed. Risk data, in general, will only be protected as 'confidential' on an exceptional basis. The party submitting the risk data has to prove that there is an imminent risk of specific and relevant harm to its commercial interests.

Efficacy and fate of glyphosate on Swedish railway embankments

The herbicide glyphosate, N-(phosphonomethyl)glycine, as Spectra (240 g AI litre(-1) SL; Monsanto Europe AB), RoundUp (360 g AI litre(-1) SL; Monsanto) and RoundUp Bio (360 g AI litre(-1) SL; Monsanto), have been used for weed control on Swedish railway embankments since 1986. This article summarizes results from studies of the weed effect and behaviour of glyphosate for the period 1984-2003. Studies on a railway embankment with a range of application rates showed excellent weed control at 5 litre ha(-1) of RoundUp Bio. The appearance of glyphosate and its metabolite AMPA [(aminomethyl)phosphonic acid] in the embankment, eg mobility and persistence, was also studied. Mobility was low in most cases, the main proportion of both glyphosate and AMPA being found in the upper 30-cm layer although minor amounts penetrated to lower depths. The 50% disappearance time of glyphosate was generally <5 months in railway embankments but cases with longer persistence were found. Transport to the groundwater was observed for glyphosate and AMPA in groundwater pipes along tracks. Downward transport appears to be dependent on the application rate, which should not exceed 3 litre ha(-1) of RoundUp Bio to avoid groundwater contamination. A lower rate of glyphosate mixed with a low rate of another herbicide may achieve acceptable weed control and be environmentally safer.

Case histories of dust explosions

AbstractThree dust explosion incidents that occurred within Monsanto Europe are discussed. The company carries out a wide range of operations involving powdered solids, and the incidents illustrate the range of situations that can cause dust explosions. The design approaches used now, covered by guides such as the NFPA 68 and 69 usually prevent major losses, but there are some lessons to be learned from the three incidents described. The most basic one is that there are so many different ways of igniting flammable dusts that we should never use elimination of ignition sources as the sole method of protection. The other lesson is a very old one: the need to maintain all our equipment and safety systems in operational condition at all times. This is particularly difficult in practice because these systems are not required for day‐to‐day production, but still must operate effectively when they are needed.