Scientific opinion on an application by Dow AgroSciences LLC (EFSA-GMO-NL-2012-106) for the placing on the market of genetically modified herbicide-tolerant soybean DAS-44406-6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Abstract Soybean DAS‐44406‐6 expresses 5‐enolpyruvyl‐shikimate‐3‐phosphate synthase (2mEPSPS), conferring tolerance to glyphosate‐based herbicides, aryloxyalkanoate dioxygenase (AAD‐12), conferring tolerance to 2,4‐dichlorophenoxyacetic acid (2,4‐D) and other related phenoxy herbicides, and phosphinothricin acetyl transferase (PAT), conferring tolerance to glufosinate ammonium‐based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food/feed safety. The agronomic and phenotypic characteristics revealed no relevant differences between soybean DAS‐44406‐6 and its conventional counterpart, except for pod count, seed cou…

Study of the aminopeptidase N gene family in the lepidopterans Ostrinia nubilalis (Hübner) and Bombyx mori (L.): Sequences, mapping and expression

Aminopeptidases N (APNs) are a class of ectoenzymes present in lepidopteran larvae midguts, involved in the Bacillus thuringiensis (Bt) toxins mode of action. In the present work, seven aminopeptidases have been cloned from the midgut of Ostrinia nubilalis, the major Lepidopteran corn pest in the temperate climates. Six sequences were identified as APNs because of the presence of the HEXXH(X)18E and GAMEN motifs, as well as the signal peptide and the GPI-anchor sequences. The remaining sequence did not contain the two cellular targeting signals, indicating it belonged to the puromycin-sensitive aminopeptidase (PSA) family. An in silico analysis allowed us to find orthologous sequences in Bo…

Alien Insect Impact on Cultural Heritage and Landscape: an Underestimated Problem

The impact of alien invasive insects on cultural heritage and landscapes is very often neglected; even though, more than 50% of species that threaten cultural heritage in Europe are of exotic origin. In addition they are more aggressive. Several examples and a description, are given of the most dangerous alien insects present in heritage sites that constitute a risk for the conservation of cultural property: museum collections, libraries, archives and historic buildings. Globalisation has increased this phenomenon but traces of the accidental introduction of insect pests have occurred since Roman times. The paper discusses the need to implement an estimation of the costs that arise from the…

What does happen when an insect pest follows its host plant and viceversa?

Invasive species are usually well known but only make up a small percentage of the European’s alien plants and insects. The ways these exotic species interact with our natural and cultural heritage are very complex and even some species considered invasive had and could have positive aspects on some European landscape and culture. A close look at the complicated relationship between non-native and native plants and insects in the Mediterranean areas reveals some unexpected twists in the story. Here are some cases of when aliens can threaten our cultural heritage or being part of it

Bacteria, fungi and arthropod pests collected on modern human mummies

A survey of opportunistic biocenosis (macro and micro organisms) associated with a rest of human mummy samples was carried out to characterise the biocenosis and to detect the potential of biodeteriogens. The rests of the human modern mummies come from a hypogeic site. Since mummies are relevant from a historic-artistic-scientific point of view, an aspect of this study was the identification and characterization of the biological systems related with biodeterioration of organic matter. In a first step, different sampling methods, according to the taxa, were applied. Technological procedures were combined in order to have an interdisciplinary approach to the conservation actions for testing …

Il punteruolo delle palme

Transmission of PPV-M to Prunus persica by Brachycaudus schwartzi and Phorodon Humuli (Hem. Aphididae)

Aphids are reported to be vectors of the most serious viral pathogen of the drupaceous species plum pox virus (PPV), but there is little direct experimental evidence of this. PPV (serotype M) is widespread in peach orchards even where there are severe control measures. Laboratory bioassays were conducted to study, under controlled conditions, the ability of Brachycaudus schwartzi (Borner) and Phorodon humuli (Schrank) to transmit PPV (serotype M). The results have shown that all the peach trees tested had evident symptoms of sharka and were positive to the RT-PCR analysis, confirming the ability of these two aphid species to transmit the virus.

Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐123)

Abstract Maize 4114 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection against certain lepidopteran and coleopteran pests by expression of the Cry1F, Cry34Ab1 and Cry35Ab1 proteins derived from Bacillus thuringiensis, and tolerance to the herbicidal active ingredient glufosinate‐ammonium by expression of the PAT protein derived from Streptomyces viridochromogenes. The molecular characterisation data did not identify issues requiring assessment for food/feed safety. None of the compositional, agronomic and phenotypic differences identified between maize 4114 and the non‐genetically modified (GM) comparator(s) required further assessment. There were …

Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐94)

The three-event stack cotton GHB614 x LLCotton25 x MON 15985 was produced by conventional crossing to combine three single cotton events, GHB614, LLCotton25 and MON 15985. The EFSA GMO Panel previously assessed the three single events and did not identify safety concerns. No new data on the single events that could lead to modification of the original conclusions on their safety were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events and of the newly expressed proteins in the three-event stack cotton did not give rise to food and feed safety or nutritional issues. Food and feed derived from cotton GHB614 x LLCott…

THE PALERMO CAPUCHIN CATACOMBS PROJECT: A MULTIDISCIPLINARY APPROACH TO THE STUDY OF A MODERN MUMMY COLLECTION (CA 1600-1900).

In this paper we present a multidisciplinary project for the study of the present conditions, history, bioanthropological features and conservation status of a large collection of modern human mummies, kept in the Capuchin Catacombs of Palermo (Sicily, Italy). Due to the large amount of spontaneously and anthropogenically mummified human bodies, and to an abundant presence of associated artefacts, this collection provides a unique opportunity to carry out a large multidisciplinary survey useful for a thorough biocultural understanding of these remains, a conservation plan, and testing of new restoration protocols.

A mathematical model of exposure of nontarget Lepidoptera to Bt-maize pollen expressing Cry1Ab within Europe

Genetically modified (GM) maize MON810 expresses a Cry1Ab insecticidal protein, derived from Bacillus thuringiensis ( Bt ), toxic to lepidopteran target pests such as Ostrinia nubilalis . An environmental risk to non-target Lepidoptera from this GM crop is exposure to harmful amounts of Bt -containing pollen deposited on host plants in or near MON810 fields. An 11-parameter mathematical model analysed exposure of larvae of three non-target species: the butterflies Inachis io (L.), Vanessa atalanta (L.) and moth Plutella xylostella (L.), in 11 representative maize cultivation regions in four European countries. A mortality–dose relationship was integrated with a dose–distance relationship t…

Assessment of genetically modified maize Bt11 x MIR162 x 1507 x GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2010‐86)

In this opinion, the GMO Panel assessed the four-event stack maize Btll x MIR162 x 1507 x GA21 and three of its subcombinations, independently of their origin. The GMO Panel previously assessed the four single events and seven of their combinations and did not identify safety concerns. No new data on the single events or the seven subcombinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events in the four-event stack maize did not give rise to food/feed safety issues. Based on the nutritional assessment of the compositional characteristics of maize Btll …

Ecological risk assessment of agricultural soils for the definition of soil screening values: A comparison between substance-based and matrix-based approaches

The Italian legislation on contaminated soils does not include the Ecological Risk Assessment (ERA) and this deficiency has important consequences for the sustainable management of agricultural soils. The present research compares the results of two ERA procedures applied to agriculture (i) one based on the “substance-based” approach and (ii) a second based on the “matrix-based” approach. In the former the soil screening values (SVs) for individual substances were derived according to institutional foreign guidelines. In the latter, the SVs characterizing the whole-matrix were derived originally by the authors by means of experimental activity.\ud \ud \ud The results indicate that the “matr…

Evaluating Resistance to Bt Toxin Cry1Ab by F<SUB>2</SUB> Screen in European Populations of Ostrinia nubilalis (Lepidoptera: Crambidae)

ABSTRACT The large-scale cultivation of transgenic crops producing Bacillus thuringiensis (Bt) toxins have already lead to the evolution of Bt resistance in some pest populations targeted by these crops. We used the F2 screening method for further estimating the frequency of resistance alleles of the European corn borer, Ostrinia nubilalis (Hubner) (Lepidoptera: Crambidae), to Bt maize, Zea mays L., producing the CrylAb toxin. In France, Germany, and Italy, 784, 455, and 80 lines of European corn borer were screened for resistance to Mon810 maize, respectively. In Slovakia, 26 lines were screened for resistance to the CrylAb toxin. The cost of F2 screen performed in the four countries varie…

Acute toxicity tests using earthworms to estimate ecological quality of compost and digestate

Ecological quality of compost and digestate, used as fertilizers for agricultural use, was assessed through an acute ecotoxicological bioassay testing the earthworm Eisenia fetida (Annelida). The test evaluates the earthworm’s attitude to dig within 15 min into a soil medium constituted by a mixture of a standardized soil and different concentrations of compost/digestate. According to different classes of behavior responses, the sample is classified as good or bad quality (ON/OFF). The validity of this test was confirmed comparing the observations with the results from a standard chronic test developed by OECD (Organisation for Economic Co-operation and Development). Considering samples fro…

Hemocytes of Rhynchophorus ferrugineus (Olivier)(Coleoptera: Curculionidae) and their response to Saccharomyces cerevisiae and Bacillus thuringiensis

Originally from tropical Asia, the Red Palm Weevil (RPW Rhynchophorus ferrugineus (Olivier) is the most dangerous and deadly pest of many palm trees, and there have been reports of its recent detection in France, Greece and Italy. At present, emphasis is on the development of integrated pest management based on biological control rather than on chemical insecticides, however the success of both systems is often insufficient. In this regard, RPW appears to be one pest that is very difficult to control. Thus inves- tigations into the natural defences of this curculionid are advisable. RPW hemocytes, the main immuno- competent cells in the insect, are described for the first time. We identifie…

Towards a landscape scale management of pesticides: ERA using changes in modelled occupancy and abundance to assess long-term population impacts of pesticide

Pesticides are regulated in Europe and this process includes an environmental risk assessment (ERA) for nontarget arthropods (NTA). Traditionally a non-spatial or field trial assessment is used. In this study we exemplify the introduction of a spatial context to the ERA as well as suggest a way in which the results of complex models, necessary for proper inclusion of spatial aspects in the ERA, can be presented and evaluated easily using abundance and occupancy ratios (AOR). We used an agent-based simulation system and an existing model for a wide-spread carabid beetle (Bembidion lampros), to evaluate the impact of a fictitious highly-toxic pesticide on population density and the distributi…

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

Question number: EFSA-Q-2015-00432On request from: European Commission; 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 PME…

Synthesis and biofilm formation reduction of pyrazole-4-carboxamide derivatives in some Staphylococcus aureus strains

The ability of several N-phenyl-1H-pyrazole-4-carboxamide derivatives and other pyrazoles opportunely modified at the positions 3, 4 and 5, to reduce the formation of the biofilm in some Staphylococcus aureus strains (ATCC 29213, ATCC 25923 and ATCC 6538) were investigated. All the tested compounds were able, although to a different extent, to reduce the biofilm formation of the three bacterial strains considered. Among these, the 1-(2,5-dichlorophenyl)-5-methyl-N-phenyl-1H-pyrazole-4-carboxamide 14 resulted as the best inhibitor of biofilm formation showing an IC50 ranging from 2.3 to 32 μM, against all the three strains of S. aureus. Compound 14 also shows a good protective effect in vivo…

MOESM1 of Response to Kruse-Plass et al. (2017) regarding the risk to non-target lepidopteran larvae exposed to pollen from one or more of three Bt maize events (MON810, Bt11 and 1507)

Additional file 1. Additional information.

Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants

Abstract As part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel, 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. The European Commission has mandated EFSA to develop a technical note to the applicants on, and checking of, the quality of the methodology, analysis and reporting covering complete sequencing of the insert and flanking regions, insertion site analysis of the GM event, and generational stability and integrity. This Technical Note puts together requirements and r…

Response to Kruse-Plass et al. (2017) regarding the risk to non-target lepidopteran larvae exposed to pollen from one or more of three Bt maize events (MON810, Bt11 and 1507)

We respond to the paper of Kruse-Plass et al. (Environ Sci Eur 29:12, 2017), published in this journal, regarding the risk to non-target lepidopteran larvae exposed to pollen from one or more of three Bt maize events (MON810, Bt11 and 1507). We emphasise that what is important for environmental risk assessment is not the number of pollen grains per se, but the degree of exposure of a NT lepidopteran larva to Bt protein contained in maize pollen. The main text of this response deals with general issues which Kruse-Plass et al. have failed to understand; more detailed refutations of each of their claims are given in Additional file 1. Valid environmental risk assessment requires direct measur…

The gut microbiota of larvae of Rhynchophorus ferrugineus Oliver (Coleoptera: Curculionidae)

Background: The red palm weevil (RPW) Rhynchophorus ferrugineus Olivier (Coleoptera: Curculionidae) is one of the major pests of palms. The larvae bore into the palm trunk and feed on the palm tender tissues and sap, leading the host tree to death. The gut microbiota of insects plays a remarkable role in the host life and understanding the relationship dynamics between insects and their microbiota may improve the biological control of insect pests. The purpose of this study was to analyse the diversity of the gut microbiota of field-caught RPW larvae sampled in Sicily (Italy). Results: The 16S rRNA gene-based Temporal Thermal Gradient Gel Electrophoresis (TTGE) of the gut microbiota of RPW …

Systematic review of the effects of chemical insecticides on four common butterfly families

Safeguarding crop productivity by protecting crops from pest attacks entails the wide use of plant protection products that provide a quick, easy and cheap solution. The objective of this study is to understand the effects of insecticides used in agriculture on non-target butterflies, specifically on the families Lycaenidae, Nymphalidae, Hesperiidae, and Papilionidae. To achieve this goal, a formal systematic review was performed according to European Food Safety Authority (EFSA) guidelines, by entering a combination of keywords on 3 online databases. Three reviewers independently extracted information on study characteristics and quality. The main results were collected and grouped by the …

Resistant management of Bt corn and sustainability in Italy

The Resistant Management (RM) of Bt corn in US requires 20% refuge area planted with non transgenic maize to preserve susceptible individuals of the pest. In Europe, especially in Italy, different considerations are necessary when RM plans are to be applied. In fact, when determining the size of the refuge areas other aspects around the transgenic corn, such as the surface of co-existing plans and other crops, must be considered. ECB is a polyphagous insect and its biology must be taken into account in the RM, especially in Italy where several crops and natural areas exist close to each other, and where field surfaces are clearly smaller than in the US. An important aspect of RM is the dete…

Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐DE‐2011‐95) for the placing on the market of genetically modified maize 5307 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG taking into consideration an additional toxicological study

Abstract The GMO Panel was previously not in the position to complete the food/feed safety assessment of maize 5307 due to an inadequate 28‐day toxicity study necessary for an appropriate assessment of eCry3.1Ab protein. Following a mandate from the European Commission, the GMO Panel assessed a supplementary 28‐day toxicity study in mice on the eCry3.1Ab protein (1,000 mg/kg body weight (bw) per day) to complement its scientific opinion on application EFSA‐GMO‐DE‐2011‐95 for the placing on the market of the maize 5307 for food and feed uses, import and processing. The supplementary 28‐day toxicity study did not show adverse effects. Taking into account the previous assessment and the new in…

Could Europe Apply a Suitable Control Method for the Small Hive Beetle (Coleoptera: Nitidulidae)?

Abstract The European bee, Apis mellifera L. (Hymenoptera: Apidae), is a fundamental resource for the pollination of a great variety of botanical species used by humans for sustenance. Over the last few decades, bee colonies have become vulnerable to a new pest that has advanced beyond its native sub-Saharan territory: the small hive beetle, Aethina tumida Murray (Coleoptera: Nitidulidae). This currently presents a pressing problem in the United States and Australia, but it has also been recorded in Portugal and Italy and it is likely to spread in the rest of Europe too. This study represents a systematic review, based on EFSA guidelines, of the various control treatments for small hive bee…

Assessment of genetically modified oilseed rape MS8, RF3 and MS8×RF3 for renewal of authorisation under regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐004)

Efsa Panel On Genetically Modified Organisms (gmo)Opinion scientificRequestor: European CommissionQuestion number: EFSA-Q-2016-00569; Following the submission of application EFSA-GMO-RX-004 under Regulation (EC) No 1829/2003 from Bayer CropScience, 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 of the genetically modified (GM) herbicide-tolerant oilseed rape MS8, RF3 and MS89RF3. The data received in the context of this renewal application contain post-market environmental monitoring reports, systematic searches and…

NEMATODE COLONIZATION OF PYRITE CINDER-POLLUTED SOIL

The nematofauna was studied in the early stages of a remediation trial at an industrial site where pyrite cinders had accumulated for 40 years in a large area and were then covered with mineral soil. The cinders were contaminated with several metals and metalloids. The soil of the experimental plots was derived from the mixture of cinders with the covering soil in a 1:1 ratio. Plots were amended with manure and sown with 3 metal resistant plants: Sorghum bicolor L., Helianthus annuus L., and Arundo donax L. Samples were taken : a) at the beginning of the trial on the pyrite cinders and covering soil, separately; b) from the mixture before the application of manure; c) from cultivated plots.…

Biological Responses of <I>Rhynchophorus ferrugineus</I> (Coleoptera: Curculionidae) to <I>Steinernema carpocapsae</I> (Nematoda: Steinernematidae)

Rhynchophorus ferrugineus (Olivier 1790) (Coleoptera: Curculionidae) is becoming a serious problem in Mediterranean areas where it is well-adapted, and now is present even in the United States (California). The infestations are primarily in urban areas where chemical control is not advisable and million of Euros are spent to control it. The effects of the entomopathogenic nematode Steinernema carpocapsae (Nematoda: Steinernematidae) on mortality, growth, as well as the immune activity of R. ferrugineus larvae, were investigated. R. ferrugineus mortality exhibited a positive trend with the dosage and duration of exposure to S. carpocapsae. The median lethal dose and median lethal time, impor…

Erratum to “Exotic insect pests: The impact of the Red Palm Weevil on natural and cultural heritage in Palermo (Italy)” [J. Cult. Herit. 14 (3S) (2013) e172–e182]

The correct caption for Figure 4 is: Palm groves with Phoenix canariensis palm trees: (a) Cittadella Universitaria (photo already published n S. Colazza, G. Filardo, A. Motisi, G. Barbera 2009. Il campo sperimentale del “giardinetto delle palme” dell’Ateneo palermitano di viale elle Scienze. In La ricerca scientifica sul punteruolo rosso e gli altri fitofagi delle palme in sicilia. (pp. 21–24). Marsala TP: Regione Siciliana ssessorato Agricoltura e Foreste and (b) Palm promenade in Foro Italico; only one palm is present.

Guidance on allergenicity assessment of genetically modified plants

Abstract This document provides supplementary guidance on specific topics for the allergenicity risk assessment of genetically modified plants. In particular, it supplements general recommendations outlined in previous EFSA GMO Panel guidelines and Implementing Regulation (EU) No 503/2013. The topics addressed are non‐IgE‐mediated adverse immune reactions to foods, in vitro protein digestibility tests and endogenous allergenicity. New scientific and regulatory developments regarding these three topics are described in this document. Considerations on the practical implementation of those developments in the risk assessment of genetically modified plants are discussed and recommended, where …

Monitoraggio e controllo di insetti infestanti le collezioni dell’erbario dell’orto botanico di Palermo

Gli erbari sono strumenti d’importante rilevanza scientifica che conservano esempi di piante rare, endemiche o estinte, e assumono essi stessi notevole interesse come beni culturali per il loro valore storico ed estetico. Gli erbari possono essere soggetti all’attacco di diverse specie d’insetti che danneggiano le piante essiccate (exsiccata) con la loro attività di alimentazione. Il controllo di queste infestazioni è spesso aggravato dalla difficoltà di poter mettere in atto trattamenti insetticidi. In tale contesto è opportuno adoperare adeguati strumenti di monitoraggio e controllo basati su sostanze attrattive feromonali o alimentari per una corretta gestione integrata degli erbari.…

Modulation of immune responses ofRhynchophorus ferrugineus(Insecta: Coleoptera) induced by the entomopathogenic nematodeSteinernema carpocapsae(Nematoda: Rhabditida)

Aim of this study was to investigate relationships between the red palm weevil (RPW) Rhynchophorus ferrugineus (Olivier) and the entomopathogenic nematode Steinernema carpocapsae (EPN); particularly, the work was focused on the immune response of the insect host in naive larvae and after infection with the EPN. Two main immunological processes have been addressed: the activity and modulation of host prophenoloxidase-phenoloxidase (proPO) system, involved in melanization of not-self and hemocytes recognition processes responsible for not-self encapsulation. Moreover, immune depressive and immune evasive strategies of the parasite have been investigated. Our results suggest that RPW possess a…

Assessment of genetically modified maize MON 87403 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐BE‐2015‐125)

GMO; maize (Zea mays); MON 87403; ear biomass; Regulation (EC) No 1829/2003; International audience; aize MON 87403 was developed to increase ear biomass at early reproductive phase through the expression of a modified AtHB17 gene from Arabidopsis thaliana, encoding a plant transcription factor of the HD-Zip II family. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87403 and its conventional counterpart were identified. The compositional analysis of maize MON 87403 did not identify differences…

Assessment of genetically modified sugar beet H7‐1 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐006)

Efsa Panel On Genetically Modified Organisms (gmo)Scientific opinionRequestor: European Commission (DG SANTE)Question number: EFSA-Q-2017-00026; Following the submission of application EFSA-GMO-RX-006 under Regulation (EC) No 1829/2003 fromKWS SAAT SE and Monsanto Company, the Panel on Genetically Modified Organisms of the EuropeanFood Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the datasubmitted in the context of the renewal of authorisation application for the herbicide-tolerantgenetically modified sugar beet H7-1. The data received in the context of this renewal applicationcontained a systematic search and evaluation of literature, updated bioinforma…

Assessment of genetically modified cotton GHB614 × T304‐40 × GHB119 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐122)

International audience; The three-event stack cotton GHB614 x T304-40 x GHB119 was produced by conventional crossing to combine three single events, GHB614, T304-40 and GHB119. The genetically modified organisms (GMO) Panel previously assessed the three single cotton events and did not identify safety concerns. No new data on the single cotton events that could lead to modification of the original conclusions on their safety were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single cotton events and of the newly expressed proteins in the three-event stack cotton did not give rise to food and feed safety concern. The GMO P…

Essential oils and their applications in agriculture and agricultural products: a literature analysis through VOSviewer.

In agriculture, more attention has been paid to limit the amount of chemical plant protection products. A potential alternative solution has been found in essential oils (EOs), which appear as promising candidates for their properties (safe, bioactive, biodegradable products) in managing plant diseases in agriculture. Therefore, a co-occurrence analysis was carried out on the available literature on Scopus database, through network maps created by VOSviewer software in order to identify the EOs used in agriculture, agricultural products and their target application. USA and India appeared as the most productive countries in terms of documents and citations followed by Iran and Italy. The co…

Essential Oils as Nematicides in Plant Protection-A Review

By 2030, the European Commission intends to halve chemical pesticide use and its consequent risks. Among pesticides, nematicides are chemical agents used to control parasitic roundworms in agriculture. In recent decades, researchers have been looking for more sustainable alternatives with the same effectiveness but a limited impact on the environment and ecosystems. Essential oils (EOs) are similar bioactive compounds and potential substitutes. Different studies on the use of EOs as nematicides are available in the Scopus database in the scientific literature. These works show a wider exploration of EO effects in vitro than in vivo on different nematode populations. Nevertheless, a review o…

Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)

Abstract Soybean MON 87751 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensis. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. None of the compositional, agronomic and phenotypic differences identified between soybean MON 87751 and the conventional counterpart required further assessment. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry1A.105 and Cry2Ab2 proteins as expressed in soybean MO…

Soil quality indicators as affected by a long term barley-maize and maize cropping systems

Most soil studies aim a better characterization of the system through indicators. In the present study nematofauna and soil structure were chosen as indicators to be assess soil health as related to agricultural practices. The field research was carried out on the two fodder cropping systems continuous maize (CM, Zea mays L.) and a 3-year rotation of silage-maize – silage-barley (Hordeum vulgare L.) with Italian ryegrass (R3) and grain-maize maintained in these conditions for 18 years. Each crop system was submitted to two management options: 1) the high input level (H), done as a conventional tillage, 2) the low input level (L), where the tillage was replaced by harrowing and the…

Part C notification (reference C/NL/13/01) from Suntory Holdings Limited for the import, distribution and retailing of carnation SHD-27531-4 cut flowers with modified petal colour for ornamental use

Requestor: European CommissionQuestion number: EFSA-Q-2015-00126; The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation SHD-27531-4 cut flowers to be imported into the European Union (EU) for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the new colour trait was observed over multiple vegetative generations. The purple colour of the petals comes from the altered expression levels of anthocyanins, common pigments found in edible fruits and vegetables. Considering the intended use of the GM carnation and the po…

Potential impact of genetically modified Lepidoptera-resistant Brassica napus in biodiversity hotspots: Sicily as a theoretical model

The general increase of the cultivation and trade of Bt transgenic plants resistant to Lepidoptera pests raises concerns regarding the conservation of animal and plant biodiversity. Demand for biofuels has increased the cultivation and importation of oilseed rape (Brassica napus L.), including transgenic lines. In environmental risk assessments (ERAs) for its potential future cultivation as well as for food and feed uses, the impact on wild Brassicaeae relatives and on non-target Lepidoptera should be assessed. Here we consider the potential exposure of butterflies as results of possible cultivation or naturalization of spilled seed in Sicily (Italy). Diurnal Lepidoptera, which are pollinat…

Does the immune answer to Bacillus thuringiensis infection is the same in larvae, females and males of Rhynchophorus ferrugineus?

Bacillus thuringiensis (Bt) è considerato un potenziale batterio entomopatogeno per la lotta al Rhynchophorus ferrugineus, coleottero da quarantena infestante le palme. In questo lavoro si considerano gli effetti dell’infezione di Bt in larve, maschi e femmine del punteruolo rosso. La patogenicità è stata valutata stimando la LD50 (Lethal Median Dose) e la LT50 (Lethal Median Time), il numero totale di emociti ed il tipo di emociti (Differential Haemocytes counts) ed inoltre l’espressione delle proteine Heat Shock Protein 70 (HSP70) negli emociti e nel cerebro. La mortalità di entrambi i sessi e delle larve aumentava all’aumentare della dose e del tempo di esposizione. Tuttavia le larve han…

Does Bacillus thuringiensis Affect the Stress and Immune Responses of Rhynchophorus ferrugineus Larvae, Females, and Males in the Same Way?

Simple Summary Rhynchophorus ferrugineus is a destructive quarantine pest of palm trees, now widely distributed. Although broad-spectrum insecticides are often used to protect palm against R. ferrugineus, there is increasing concern about their effects on the environment and human health, especially where palm trees are located in urban areas. As an environmentally friendly entomopathogen, Bacillus thuringiensis (Bt) has been widely used to prevent other pest infestations. Although Bt products are the most sold bio-insecticides, there are still many interesting features to be investigated in the relationship of Bt and its hosts. We investigated the effect of Bt on larvae, females, and males…

Scientific Opinion on application EFSA‐GMO‐BE‐2013‐117 for authorisation of genetically modified maize MON 87427 × MON 89034 × NK603 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company

Scientific opinionRequestor: Competent Authority of BelgiumQuestion number: EFSA-Q-2013-00765; In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO Panel) assessed the three-event stack maize MON 87427 9 MON 89034 9 NK603 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the three single events combined to produce this three-event stack maize and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and …

The usefulness of a mathematical model of exposure for environmental risk assessment

We respond to the Comment of Lang et al . [[1][1]] regarding our mathematical model [[2][2]] of exposure of non-target Lepidoptera to Bt -maize pollen expressing Cry1Ab within Europe. Lang et al . remark on the degree to which the model was subject to uncertainty. Perry et al . [[2][2]] did indeed

Influence of Bacterial Secondary Symbionts in Sitobion avenae on Its Survival Fitness against Entomopathogenic Fungi, Beauveria bassiana and Metarhizium brunneum

The research was focused on the ability of wheat aphids Sitobion avenae, harboring bacterial secondary symbionts (BSS) Hamiltonella defensa or Regiella insecticola, to withstand exposure to fungal isolates of Beauveria bassiana and Metarhizium brunneum. In comparison to aphids lacking bacterial secondary symbionts, BSS considerably increased the lifespan of wheat aphids exposed to B. bassiana strains (Bb1022, EABb04/01-Tip) and M. brunneum strains (ART 2825 and BIPESCO 5) and also reduced the aphids’ mortality. The wheat aphid clones lacking bacterial secondary symbionts were shown to be particularly vulnerable to M. brunneum strain BIPESCO 5. As opposed to wheat aphids carrying bacterial s…

Potential effects of transgenic cotton on soil ecosystem processes in Vietnam.

Assessment of genetically modified maize GA21 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐005)

Efsa Panel On Genetically Modified Organisms (gmo) Requestor: European Commission (DG SANTE)Question number: EFSA-Q-2016-00714Correspondence; Following the submission of application EFSA-GMO-RX-005 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, 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 of the herbicide-tolerant genetically modified maize GA21. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and eval…

Odorants of Capsicum spp. Dried Fruits as Candidate Attractants for Lasioderma serricorne F. (Coleoptera: Anobiidae)

The cigarette beetle, Lasioderma serricorne F. (Coleoptera: Anobiidae) is an important food storage pest affecting the tobacco industry and is increasingly impacting museums and herbaria. Monitoring methods make use of pheromone traps which can be implemented using chili fruit powder. The objective of this study was to assess the response of L. serricorne to the volatile organic compounds (VOCs) from different chili powders in order to identify the main semiochemicals involved in this attraction. Volatiles emitted by Capsicum annuum, C. frutescens, and C. chinense dried fruit powders were tested in an olfactometer and collected and analyzed using SPME and GC-MS. Results indicated that C. an…

Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003

Abstract This document provides guidance for the risk assessment under Regulation (EC) No 1829/2003 of the unintended, adventitious or technically unavoidable presence in food and feed of low level of genetically modified plant material intended for markets other than in the European Union. In this context, the presence at low level is defined to be maximum 0.9% of genetically modified plant material per ingredient. This guidance is intended to assist applicants by indicating which scientific requirements of Annex II of Regulation (EU) No 503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed.

Assessment of genetically modified maize NK603 x MON810 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐007)

Efsa Panel On Genetically Modified Organisms (gmo)Scientific opinionRequestor:European Commission (DG SANTE)Question number:EFSA-Q-2017-00028; Following the submission of application EFSA-GMO-RX-007 under Regulation (EC) No 1829/2003 from Monsanto, 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 of the herbicide-tolerant and insect-resistant genetically modified maize NK603 x MON810. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic searc…

Assessment of the ecotoxicity of phytotreatment substrate soil as landfill cover material for in-situ leachate management

Phytotreatment capping in closed landfills is a promising, cost-effective, in situ option for sustainable leachate treatment and might be synergistically coupled with energy crops to produce renewable energy (e.g.: biodiesel or bioethanol). This study proposes to use 0.30 m of soil as growing substrate for plants cultivated on the temporary cover of closed landfills. Once the leachate phytotreatment process is no longer required, 0.70 m of the same soil would be added to attain the final top cover configuration. This solution would entail saving the costs of excavation and backfilling. However, worsening of the initial soil quality due to potential contaminant transfer from the liquid to th…

Insect pests of the Herbarium of the Palermo botanical garden and evaluation of semiochemicals for the control of the key pest Lasioderma serricorne F. (Coleoptera: Anobiidae)

Abstract The herbaria are scientific tools of great importance that preserve extinct, rare, endemic, and common plant species and also have importance as Cultural Heritage for their historical and esthetical value. Herbaria can be infested by several insect pests feeding on dried plants, and their management is often complicated and difficult as the use of chemical insecticides can have negative drawbacks. This suggests a strong need for alternative control tools such as the use of semiochemicals to develop Integrated Pest Management (IPM) programs. In order to identify the main insect pests that determine the damages on the exsiccata stored in the Palermo Botanical Garden's Herbarium, one …

Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)

International audience; Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 x NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained a systematic search and evaluation of literature, updated bioin…

Assessment of genetically modified maize 1507 × 59122 × MON810 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐92)

In this opinion, the GMO Panelassessed the four-event stack maize 1507 x 59122 x MON810 x NK603 and its ten subcombinations, independently of their origin. The GMO Panelpreviously assessed the four single events combined in this four-event stack maize and five of their combinations and did not identify safety concerns. No new data on the single events or their previously assessed combinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the four-event stack maize did not give rise to food and feed safety or…

Scientific Opinion on application EFSA‐GMO‐BE‐2013‐118 for authorisation of genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company

Abstract In this opinion, the GMO Panel assessed the five‐event stack maize MON 87427 × MON 89034 ×1507 × MON 88017 × 59122 and its 25 subcombinations, independently of their origin. The GMO Panel has previously assessed the five single events combined to produce this five‐event stack maize and 11 subcombinations of these events and did not identify safety concerns. No new data on the single events or their previously assessed subcombinations, leading to modification of the original conclusions were identified. The combination of the single events and of the newly expressed proteins in the five‐event stack maize did not give rise to issues – based on the molecular, agronomic/phenotypic or c…

Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

Maize MON 87411 was developed to confer resistance to corn rootworms (Diabrotica spp.) by the expression of a modified version of the Bacillus thuringiensis cry3Bb1 gene and a DvSnf7 dsRNA expression cassette, and tolerance to glyphosate-containing herbicides by the expression of a CP4 5-enolpyruvylshikimate-3-phosphate synthase (cp4 epsps) gene. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food and feed safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87411 and its conventional counterpart were identified. The compositional analysis of maize MON 87411…

Eco-physiological response of two marine bivalves to acute exposition to commercial Bt-based pesticide

Microbial products based on the entomopathogenic bacterium Bacillus thuringiensis (Bt) are among the most common biopesticides used worldwide to suppress insect pests in forests, horticulture and agricultural crops. Some of the effects of commercial Bt have been recorded for terrestrial and freshwater non-target organisms but little research is available on marine fauna. Nevertheless, due to the contiguity of agro-ecosystems and coastal habitats, marine fauna may be highly influenced by this control method. We studied the effect of a commercial Bt product on the physiological and ecological responses and the energy budget of two of the most frequent marine intertidal bivalves in the Mediter…

Scientific Opinion addressing the state of the science on risk assessment of plant protection products for in‐soil organisms

Abstract Following a request from EFSA, the Panel on Plant Protection Products and their Residues developed an opinion on the science behind the risk assessment of plant protection products for in‐soil organisms. The current risk assessment scheme is reviewed, taking into account new regulatory frameworks and scientific developments. Proposals are made for specific protection goals for in‐soil organisms being key drivers for relevant ecosystem services in agricultural landscapes such as nutrient cycling, soil structure, pest control and biodiversity. Considering the time‐scales and biological processes related to the dispersal of the majority of in‐soil organisms compared to terrestrial non…

Risk assessment of information on the subcombination Bt11 × 1507 × GA21, related to the application of Syngenta (EFSA‐GMO‐DE‐2011‐99) for authorisation of food and feed containing, consisting and produced from genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21

Efsa Panel On Genetically Modified Organisms (gmo)StatementRequestor: European CommissionQuestion number: EFSA-Q-2016-00730; The EFSA Panel on Genetically Modified Organisms (GMO) has previously assessed the single events Bt11, MIR162, MIR604 and GA21 as well as different stacked events corresponding to combinations of these events. These maize events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. In its assessment of the four-event maize stack Bt11 9 MIR162 9 MIR604 9 GA21, the GMO Panel also assessed all the subcombinations of these events not previously assesse…

A new class of phenylhydrazinylidene derivatives as inhibitors of Staphylococcus aureus biofilm formation

In the struggle against the emergence of the antibiotic resistance, new molecules targeting biofilm formation could be useful as adjuvant of conventional antibiotics. This study focused on a new class of 2-phenylhydrazinylidene derivatives as antivirulence agents. The compound 12e showed interesting activities against biofilm formation of all tested Staphylococcus aureus strains with IC50 ranging from 1.7 to 43 µM; compounds 12f and 13a resulted strong inhibitors of S. aureus ATCC 6538 and ATCC 29213 biofilm formation with IC50 of 0.9 and 0.8 µM, respectively. A preliminary study on the mechanism of action was carried on evaluating the inhibition of sortase A transpeptidase. Compound 12e re…

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

Requestor: European CommissionQuestion number: EFSA-Q-2015-00650; 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 2014 growing season of maize MON 810 provided by Monsanto Europe S.A. The GMO Panel concludes that the insect resistance monitoring data do not indicate a decrease in susceptibility of field Iberian populations of corn borers to the Cry1Ab protein over the 2014 season. However, as the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the GMO Panel reiterates …

Exotic insect pests: The impact of the Red Palm Weevil on natural and cultural heritage in Palermo (Italy)

Abstract The impact of invasive exotic pests is increasingly recognised as a global issue. A global strategy to address the exotic pest problem is beginning to evolve, albeit slowly. The International Plant Protection Convention (FAO) has begun the process of harmonizing standards for pest risk analysis to minimise the spread of exotic pests without adversely impacting global trade. However if the impacts of insect invasive species on human health and on agriculture have attracted worldwide attention, researchers and policymakers address directly the connection between invasive species and damage to natural and cultural heritages. The cost of these losses is generally neglected or underesti…

Antimicrobial activity of the red palm weevil Rhynchophorus ferrugineus

The red palm weevil, Rhynchophorus ferrugineus (Olivier) (Coleoptera Dryophthoridae), is an important pest of palms. Knowl- edge of both its natural enemies and its defensive mechanisms against predators and microorganisms is important to develop methods for an integrated pest control. Antimicrobial activity of the cuticular surface of adults and larvae, as well as of eggs, of this invasive species was investigated. This activity was tested against the Gram-positive bacteria Bacillus subtilis (Ehrenberg) Cohn and Bacillus thuringiensis Berliner, the Gram-negative bacterium Escherichia coli Escherich, and the entomopathogenic fungi Beauveria bassiana (Balsamo) Vuillemin and Metarhizium aniso…

Scientific Opinion on an application by Syngenta (EFSA-GMO-DE-2009-66) for placing on the market of herbicide tolerant and insect resistant maize Bt11 × MIR162 × MIR604 × GA21 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Question number: EFSA-Q-2009-00444 on request from Competent Authority of Germany; The EFSA GMO Panel previously assessed the four single events combined to produce a four-event stack maize Bt11 × MIR162 × MIR604 × GA21 and did not identify safety concerns. In this opinion, the EFSA GMO Panel assesses the four-event stack maize and all its subcombinations independently of their origin. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on the four-event stack maize did not give rise to safety concerns and there is no reason to expect interactions between the singl…