This report is the outcome of an EFSA procurement (OC/EFSA/GMO/2015/02) which aims at reviewing r... more This report is the outcome of an EFSA procurement (OC/EFSA/GMO/2015/02) which aims at reviewing relevant scientific information on RNA interference (RNAi) that could serve as baseline information for the environmental risk assessment of RNAi-based genetically modified (GM) plants. The report is based on a systematic literature search on the use of RNAi molecules in arthropods, nematodes, annelids and molluscs with dsRNA, siRNA and miRNA applied primarily through feeding and soaking (oral ingestion). The numbers of retrieved publications covering these areas are reported, along with the species name, life stages tested, the target gene and its function, details of the test substances and their concentrations used, methods of delivery and effects. Separate sections discuss the available information on: (1) the uptake and systematic spread of RNAi activity, including a description of the various components involved in this process; (2) the mechanisms of dsRNA-, siRNA-and miRNA-elicited gene silencing and the different factors involved in RNAi efficiency; (3) routes of exposure of the biotic and abiotic environment to dsRNA, siRNA and miRNA from GM plants; (4) the environmental fate of dsRNA, siRNA and miRNA; and (5) the various factors that may limit non-target effects including exposure, factors influencing the silencing efficiency of dsRNA, siRNA and miRNA, possible unintended and off-target effects, and their mechanisms. Finally, an overview of the species of arthropods, nematodes, annelids and molluscs for which genomic data are available is also presented. The report identifies some of the challenges involved in developing plants with RNAi systems which affect invertebrate gene expression. The report also concludes that, currently, knowledge on issues such as exposure, specificity, offtarget effects, sequence similarities and bioinformatics is very limited, as only a few RNAi expressing plants which specifically target invertebrate species have been developed and comprehensively studied.
Genetically modified (GM) plants may show unintended differences compared to the original varieti... more Genetically modified (GM) plants may show unintended differences compared to the original varieties, due to the modification process. Such differences might in some cases affect non-target organisms linked to the crop into an agro-ecosystem. In this paper, we aimed to study interactions of two blight-resistant GM potato clones with the aphid species Macrosiphum euphorbiae Thomas, a non-target arthropod frequently feeding on potato plants and one of the major pests of that crop. One of the potato events used in our experiments caused an increased fertility of the aphids in the first generation, and consequently, a positive effect on the growth of the aphid population was estimated. When a second generation of the aphid was reared on potato leaves of the same GM event, differences in aphid fertility were no longer observed. Behavioural studies conducted in a wind tunnel using the aphid parasitoid Aphidius ervi Haliday indicated that neither of the two tested GM varieties had a significant effect on the attractiveness of potato plants towards the parasitoid. In planta tests proved to be sensitive protocols to detect unintended effects on a non-target arthropod; experimental results, however, indicate that these effects are not expected to be biologically relevant in this tritrophic system, if these GM events become available for commercial use in the future.
Environmental impacts of genetically modified crops are mandatorily assessed
during their premark... more Environmental impacts of genetically modified crops are mandatorily assessed during their premarket phase. One of the areas of concern is the possible impact on nontarget organisms. Crops expressing Cry toxins might affect Lepidoptera larvae living outside cultivated fields, through pollen deposition on wild plants, which constitute their food source. While pollen toxicity varies among different events, possible exposure of nontarget species depends on the agro-environmental conditions. This study was conducted in two protected areas in Italy, characterized by different climatic conditions, where many Lepidoptera species thrive in proximity to maize cultivations. To estimate the possible exposure in absence of the actual stressor (e.g., Cry1-expressing maize plants), we conducted a two-year field survey of butterflies and weeds. Indicator species were selected—Aglais (Inachis) io in the Northern site and Vanessa cardui in the Southern site—and their phenology was investigated. Pollen dispersal from maize fields was measured by collection in Petri dishes. Duration and frequency of exposure was defined by the overlap between pollen emission and presence of larvae on host plants. Different risk scenarios are expected in the two regions: highest exposure is foreseen for A. io in the Northern site, while minimal exposure is estimated for V. cardui in the Southern site. In the latter case, locally grown maize cultivars flower in mid-summer in coincidence with an aestivation period for several butterfly species due to hot and dry conditions. Moreover, host plants of V. cardui are at the end of their life cycle thus limiting food availability.
Maggio 2019 n. 85 foglio-Notiziario regionale di agricoltura sostenibile, 2019
Gli intendimenti della legislazione europea in matera di difesa fitosanitaria sono sempre più im-... more Gli intendimenti della legislazione europea in matera di difesa fitosanitaria sono sempre più im-pegnati verso il contenimento degli impatti delle pratiche agricole sulla salute umana e animale e sull'ambiente. Il concetto di agricoltura soste-nibile, che è alla base della conce-zione più moder-na delle attività agricole, tende infatti a coniuga-re il benessere ambientale, quel-lo economico e quello sociale. Il più grosso cam-biamento che riguarda le prati-che di difesa fito-sanitaria è sicuramente l'entrata in vigore della di-rettiva 2009/128/CE concernente l'utilizzo sostenibi-le dei pesticidi. Uno degli effetti più evidenti dell'in-troduzione di questa direttiva è senz'altro quello della revisione dei principi attivi utilizzabili in campo che ha visto una drastica riduzione del numero dei presidi sanitari, con particolare riferimento alla clas-se dei fosforganici che costituivano una parte im-portante della farmacopea a disposizione delle aziende agrarie. La disponibilità di nuovi principi attivi che possano garantire una buona efficacia contro artropodi e patogeni dannosi, accoppiati a un basso impatto ambientale e bassa tossicità, rap-presenta pertanto un obiettivo prioritario della ri-cerca in questo particolare settore. Recentemente sta destando molto interesse fra le aziende produttrici la possibilità di applicazione della tecnica del RNA interferente per un possibile utilizzo di questo meccanismo per la produzione di biopesticidi. Cos'è l'RNA interferente? La tecnica del RNA-interferente (RNAi) sfrutta un meccanismo naturale presente in organismi ve-getali e animali per portare alla perdita di funziona-lità di un gene tramite blocco delle molecole di RNA indispensa-bili per la forma-zione di una pro-teina. In natura questo meccani-smo è usato, ad esempio, negli artropodi per difendersi dall'at-tacco di alcuni virus. Il virus viene riconosciu-to dall'organismo come estraneo ed in conseguenza viene prodotta una piccola mo-lecola di RNA per bloccare la replicazione del virus. Perché il meccanismo funzioni, è necessario che questa molecola di RNA prodotta riconosca in ma-niera molto specifica la sequenza del RNA prodotta dal virus in modo da crearne una copia perfetta-mente complementare che rende quindi impossibile la formazione della proteina. Fin dalla sua scoperta, che valse il premio Nobel per la medicina a Craig Cameron Mello e An-drew Fire, l'RNAi ha catturato l'attenzione dei ri-cercatori per le sue potenzialità innanzitutto come possibile veicolo di medicinali per terapia genica, ma successivamente anche in tanti altri campi di applicazione, inclusa l'agricoltura. Relativamente alla difesa fitosanitaria, la prima applicazione commerciale è stata ottenuta dalla Monsanto (ora Bayer) e riguarda la produzione di un mais geneticamente modificato (denominato (Connua a pagina 11)
This paper considers the statistical analysis of entomological count data from field experiments ... more This paper considers the statistical analysis of entomological count data from field experiments with genetically modified (GM) plants. Such trials are carried out to assess environmental safety. Potential effects on nontarget organisms (NTOs), as indicators of biodiversity, are investigated. The European Food Safety Authority (EFSA) gives broad guidance on the environmental risk assessment (ERA) of GM plants. Field experiments must contain suitable comparator crops as a benchmark for the assessment of designated endpoints. In this paper, a detailed protocol is proposed to perform data analysis for the purpose of assessing environmental safety. The protocol includes the specification of a list of endpoints and their hierarchical relations, the specification of intended levels of data analysis, and the specification of provisional limits of concern to decide on the need for further investigation. The protocol emphasizes a graphical representation of estimates and confidence intervals for the ratio of mean abundances for the GM plant and its comparator crop. Interpretation relies mainly on equivalence testing in which confidence intervals are compared with the limits of concern. The proposed methodology is illustrated with entomological count data resulting from multiyear, multilocation field trials. A cisgenically modified potato line (with enhanced resistance to late blight disease) was compared to the original conventional potato variety in the Netherlands and Ireland in two successive years (2013, 2014). It is shown that the protocol encompasses alternative schemes for safety assessment resulting from different research questions and/or expert choices. Graphical displays of equivalence testing at several hierarchical levels and their interpretation are presented for one of these schemes. The proposed approaches should be of help in the ERA of GM or other novel plants.
The yield of several commodity crops is provided in large part by genetically modified crops in N... more The yield of several commodity crops is provided in large part by genetically modified crops in North and South America. However, reservations exist in Europe due to possible negative effects on human health or environment. This paper aims to analyse the current research priorities identified in EU countries and to engage European stakeholders into the formulation of future common research needs regarding the effects of the possible adoption of commercially available and forthcoming genetically modified organisms (GMOs) in the areas of socio-economics, human and animal health, and environment. Additionally, it aims to identify the requirements for sharing available research capacities and existing infrastructures. First a mapping exercise of existing research activities in Europe was performed. A questionnaire was developed on a web-based platform and submitted to national focal points to collect information from EU Member States. Information was collected from 320 research projects conducted in the last 10 years in Europe. To refine results of the surveys, twenty invited experts and stake-holders from the public funding agencies of different EU Member States participated in an international workshop. This paper reports the main findings of these activities.
Insect–plant interactions may be unintentionally affected when introducing genetically modified (... more Insect–plant interactions may be unintentionally affected when introducing genetically modified (GM) crops into an agro-ecosystem. Our aim was to test the non-target effects of a late blight-resistant GM potato on Myzus per-sicae in greenhouse and climate room experiments and understand how position and number of R gene insertions can affect non-targets in GM events. We also aimed to compare results to baseline differences among three conventional potato varieties varying in resistance to late blight. Aphid development and survival were affected by some GM events in the first generation, though effects disappeared in the second generation. Effects were not dependent on the presence of a marker gene or the insertion of a second resistance gene. Positional effects of gene insertion influenced aphid performance on certain GM events. However, aphid fitness varied considerably more between conventional potato varieties than between Désirée and the GM events. Comparing different GM events to the non-transformed variety is relevant, since unintended effects of insertion can occur. Our protocols can be recommended for in planta risk assessments with aphids. Ecological perspective is gained by selecting several measured endpoints and by comparing the results with a baseline of conventional cultivars. • We investigated the hypothesis that characteristics of a GM potato may influence the non-target aphid Myzus persicae. • Aphid performance was affected by the resistance gene position but not by the number of resistance genes or the presence of an antibiotic resistance marker gene. • Aphid performance varied considerably more between conventional cultivars than between the unmodified and the GM potato. • These findings support future protocols for risk assessments of GM crops on non-target insects.
This document provides guidance for the environmental risk assessment (ERA) of genetically modifi... more This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six steps for the ERA of GM plants, as indicated in Directive 2001/18/EC, starting with (1) problem formulation including hazard identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The scientific Panel on Genetically Modified Organisms (of the European Food Safety Authority (EFSA GMO Panel) considers seven specific areas of concern to be addressed by applicants and risk assessors during the ERA (1) persistence and invasiveness of the GM plant , or its compatible relatives, including plant-to-plant gene transfer ; (2) plant-to-microorganism gene transfer; (3) interaction of the GM plant with target organisms and (4) interaction of the GM plant with non-target organisms, including criteria for selection of appropriate species and relevant functional groups for risk assessment; (5) impact of the specific cultivation, management and harvesting techniques; including consideration of the production systems and the receiving environment(s); (6) effects on biogeochemical processes; and (7) effects on human and animal health. Each specific area of concern is considered in a structured and systematic way following the above-mentioned steps (1 to 6). In addition, the guidance document is supplemented with several general cross-cutting considerations (e.g. choice of comparator, receiving environment(s), general statistical principles, long-term effects) that need to be considered in the ERA.
The European Food Safety Authority (EFSA) asked the Panel on Genetically Modified Organisms to es... more The European Food Safety Authority (EFSA) asked the Panel on Genetically Modified Organisms to establish a self-tasking Working Group with the aim of (1) producing a scientific review of the current guidance of the GMO Panel for Environmental Risk Assessment (ERA), focusing on the potential impacts of GM plants on Non-Target Organisms (NTOs), (2) proposing criteria for NTOs selection, and (3) providing advise on standardized testing methodology. This initiative was undertaken in response to a need and request from a wide range of stakeholders, including the European Commission and Member States. In first instance, the self-tasking Working Group on Non-Target Organisms (EFSA NTO WG) mainly considered impacts of GM plants on invertebrate species, but also took account of ecosystem functions that could be altered. The EFSA NTO WG considered the necessity for clear and objective protection goals, for which assessment and measurement endpoints shall be developed; the need to initiate the scientific risk assessment by setting testable hypotheses; criteria for appropriate selection of test species and ecological functional groups; appropriate laboratory and field studies to collect relevant NTO data; and the use of statistical techniques that should be an integral part of experimental design. The EFSA NTO WG considered the range of approaches and methodologies of ERA of NTOs as described in the current literature and proposed risk assessment approaches based on selection of functional groups and individual species within a tiered approach. The present scientific opinion provides guidance to risk assessors for assessing potential effects of GM plants on NTOs, together with rationale for data requirements in order to complete a comprehensive ERA for NTOs. In this respect, guidance to applicants as outlined in the present opinion has been inserted in the updated Guidance Document of the EFSA GMO Panel for the ERA of GM plants. Zwahlen for the preparatory work on this scientific opinion, and EFSA staff: Sylvie Mestdagh for the support provided to this scientific opinion. In addition the Panel wishes to thank the three external referees, including Sue Hartley and Gabor Lövei, for reviewing an early draft of the document during its development phase, as well as Toby Bruce and Joop van Loon for providing technical input.
GM-crops and their potential environmental
risks are still controversial in the
EU.
• Earthworms ... more GM-crops and their potential environmental risks are still controversial in the EU. • Earthworms are important non-target organisms in arable soils. • Focal species are selected based on literature data following a four-step procedure. • Selection highly representative for EU biogeographical regions under maize or potato. • Selected focal species are recommended for testing based on life-history traits.
Ladybird beetles (Coleoptera Coccinellidae) are important predators of aphids and other crop pest... more Ladybird beetles (Coleoptera Coccinellidae) are important predators of aphids and other crop pests, and there is great interest in their conservation in agroecosystems. Bt-maize, genetically engineered to express insecticidal Cry proteins, is regarded as a taxon-specific way of controlling pests, but some concerns have been raised about the possibility of unintended negative effects on non-target organisms, including coccinellids. One of the possible routes of exposure of ladybird beetles to Cry toxins is by feeding on maize pollen, as for many species pollen is an important integrative food source. In this study, coccinellid adults were sampled by sweep netting in Ecological Compensation Areas (ECAs) in three sites of Northern and Central Italy, where conventional maize cultivars are grown (Bt-maize is currently forbidden for commercial cultivation in Italy). The coccinellid communities were sampled during and around the typical flowering periods of maize in order to check their diversity and their overlap with pollen shedding. A total of 11 species were recorded. Hippodamia variegata (Goeze), Coccinella septempunctata L. and the exotic Harmonia axyridis (Pallas) were the most abundant species in Northern Italy, whereas Tytthaspis sedecimpunctata (L.) and Coccinula quatuordecimpustulata (L.) were dominant in Central Italy. The potential exposure to maize pollen was different in the two areas, since in Northern Italy the maize flowering coincided with a period of high coccinellid activity in the field, whereas in Central Italy the ladybird population peaks occurred roughly one month earlier than the anthesis. The collected data might be useful for exposure characterization of ladybird beetles in a possible future scenario of Bt-maize cropping in the studied areas.
L’esigenza di protezione dei siti di importanza comunitaria dovrebbe tener conto anche dei possib... more L’esigenza di protezione dei siti di importanza comunitaria dovrebbe tener conto anche dei possibili impatti ambientali delle attività agricole eseguite nelle aree protette o contigue ad esse. Il progetto MAN-GMP-ITA (Validation of risk management tools for genetically modified plants in protected and sensitive areas in Italy) è finalizzato alla valutazione dei rischi di una eventuale coltivazione di piante geneticamente modificate (PGM) per aree protette e sensibili (www.man-gmp-ita.sinanet.isprambiente.it). Il progetto, finanziato dalla Commissione Europea nell’ambito del programma LIFE+, è stato sviluppato in aree protette di Emilia-Romagna, Lazio, Basilicata, Puglia e Sicilia, con il coordinamento di ENEA - C. R. Trisaia e la collaborazione di CRA-RPS (Roma), ISPRA (Roma), Università degli Studi di Bologna e Università degli Studi di Palermo. L’attività di ricerca svolta si propone di: individuare alcuni obiettivi di protezione specifici per aree protette o sensibili prossime ad aree agricole; selezionare schemi di monitoraggio ed indicatori ambientali per la gestione dell’impatto ambientale di PGM; validare una metodologia per il monitoraggio e la gestione di possibili effetti di PGM sulla biodiversità. Preliminare ad ogni valutazione del rischio di impatto ambientale è la conoscenza dell’ ambiente ricevente per poter stabilire degli obiettivi di protezione specifici; nelle aree protette italiane, spesso tale conoscenza è limitata rendendo difficile l’individuazione di tali obiettivi di protezione. Questa rassegna tende a supportare il lavoro dei gestori dell’area protetta SIC IT 9220090 “Costa Jonica - Foce Bradano” per la corretta gestione dei possibili rischi ambientali nell’area protetta, derivanti da attività antropiche e non soltanto quelle legate al settore agricolo. Il formato della pubblicazione intende poi specificamente offrire un contributo per la valorizzazione dell’area ed una fruizione da parte del pubblico per scopi conoscitivi ed estetici.
This report is the outcome of an EFSA procurement (OC/EFSA/GMO/2015/02) which aims at reviewing r... more This report is the outcome of an EFSA procurement (OC/EFSA/GMO/2015/02) which aims at reviewing relevant scientific information on RNA interference (RNAi) that could serve as baseline information for the environmental risk assessment of RNAi-based genetically modified (GM) plants. The report is based on a systematic literature search on the use of RNAi molecules in arthropods, nematodes, annelids and molluscs with dsRNA, siRNA and miRNA applied primarily through feeding and soaking (oral ingestion). The numbers of retrieved publications covering these areas are reported, along with the species name, life stages tested, the target gene and its function, details of the test substances and their concentrations used, methods of delivery and effects. Separate sections discuss the available information on: (1) the uptake and systematic spread of RNAi activity, including a description of the various components involved in this process; (2) the mechanisms of dsRNA-, siRNA-and miRNA-elicited gene silencing and the different factors involved in RNAi efficiency; (3) routes of exposure of the biotic and abiotic environment to dsRNA, siRNA and miRNA from GM plants; (4) the environmental fate of dsRNA, siRNA and miRNA; and (5) the various factors that may limit non-target effects including exposure, factors influencing the silencing efficiency of dsRNA, siRNA and miRNA, possible unintended and off-target effects, and their mechanisms. Finally, an overview of the species of arthropods, nematodes, annelids and molluscs for which genomic data are available is also presented. The report identifies some of the challenges involved in developing plants with RNAi systems which affect invertebrate gene expression. The report also concludes that, currently, knowledge on issues such as exposure, specificity, offtarget effects, sequence similarities and bioinformatics is very limited, as only a few RNAi expressing plants which specifically target invertebrate species have been developed and comprehensively studied.
Genetically modified (GM) plants may show unintended differences compared to the original varieti... more Genetically modified (GM) plants may show unintended differences compared to the original varieties, due to the modification process. Such differences might in some cases affect non-target organisms linked to the crop into an agro-ecosystem. In this paper, we aimed to study interactions of two blight-resistant GM potato clones with the aphid species Macrosiphum euphorbiae Thomas, a non-target arthropod frequently feeding on potato plants and one of the major pests of that crop. One of the potato events used in our experiments caused an increased fertility of the aphids in the first generation, and consequently, a positive effect on the growth of the aphid population was estimated. When a second generation of the aphid was reared on potato leaves of the same GM event, differences in aphid fertility were no longer observed. Behavioural studies conducted in a wind tunnel using the aphid parasitoid Aphidius ervi Haliday indicated that neither of the two tested GM varieties had a significant effect on the attractiveness of potato plants towards the parasitoid. In planta tests proved to be sensitive protocols to detect unintended effects on a non-target arthropod; experimental results, however, indicate that these effects are not expected to be biologically relevant in this tritrophic system, if these GM events become available for commercial use in the future.
Environmental impacts of genetically modified crops are mandatorily assessed
during their premark... more Environmental impacts of genetically modified crops are mandatorily assessed during their premarket phase. One of the areas of concern is the possible impact on nontarget organisms. Crops expressing Cry toxins might affect Lepidoptera larvae living outside cultivated fields, through pollen deposition on wild plants, which constitute their food source. While pollen toxicity varies among different events, possible exposure of nontarget species depends on the agro-environmental conditions. This study was conducted in two protected areas in Italy, characterized by different climatic conditions, where many Lepidoptera species thrive in proximity to maize cultivations. To estimate the possible exposure in absence of the actual stressor (e.g., Cry1-expressing maize plants), we conducted a two-year field survey of butterflies and weeds. Indicator species were selected—Aglais (Inachis) io in the Northern site and Vanessa cardui in the Southern site—and their phenology was investigated. Pollen dispersal from maize fields was measured by collection in Petri dishes. Duration and frequency of exposure was defined by the overlap between pollen emission and presence of larvae on host plants. Different risk scenarios are expected in the two regions: highest exposure is foreseen for A. io in the Northern site, while minimal exposure is estimated for V. cardui in the Southern site. In the latter case, locally grown maize cultivars flower in mid-summer in coincidence with an aestivation period for several butterfly species due to hot and dry conditions. Moreover, host plants of V. cardui are at the end of their life cycle thus limiting food availability.
Maggio 2019 n. 85 foglio-Notiziario regionale di agricoltura sostenibile, 2019
Gli intendimenti della legislazione europea in matera di difesa fitosanitaria sono sempre più im-... more Gli intendimenti della legislazione europea in matera di difesa fitosanitaria sono sempre più im-pegnati verso il contenimento degli impatti delle pratiche agricole sulla salute umana e animale e sull'ambiente. Il concetto di agricoltura soste-nibile, che è alla base della conce-zione più moder-na delle attività agricole, tende infatti a coniuga-re il benessere ambientale, quel-lo economico e quello sociale. Il più grosso cam-biamento che riguarda le prati-che di difesa fito-sanitaria è sicuramente l'entrata in vigore della di-rettiva 2009/128/CE concernente l'utilizzo sostenibi-le dei pesticidi. Uno degli effetti più evidenti dell'in-troduzione di questa direttiva è senz'altro quello della revisione dei principi attivi utilizzabili in campo che ha visto una drastica riduzione del numero dei presidi sanitari, con particolare riferimento alla clas-se dei fosforganici che costituivano una parte im-portante della farmacopea a disposizione delle aziende agrarie. La disponibilità di nuovi principi attivi che possano garantire una buona efficacia contro artropodi e patogeni dannosi, accoppiati a un basso impatto ambientale e bassa tossicità, rap-presenta pertanto un obiettivo prioritario della ri-cerca in questo particolare settore. Recentemente sta destando molto interesse fra le aziende produttrici la possibilità di applicazione della tecnica del RNA interferente per un possibile utilizzo di questo meccanismo per la produzione di biopesticidi. Cos'è l'RNA interferente? La tecnica del RNA-interferente (RNAi) sfrutta un meccanismo naturale presente in organismi ve-getali e animali per portare alla perdita di funziona-lità di un gene tramite blocco delle molecole di RNA indispensa-bili per la forma-zione di una pro-teina. In natura questo meccani-smo è usato, ad esempio, negli artropodi per difendersi dall'at-tacco di alcuni virus. Il virus viene riconosciu-to dall'organismo come estraneo ed in conseguenza viene prodotta una piccola mo-lecola di RNA per bloccare la replicazione del virus. Perché il meccanismo funzioni, è necessario che questa molecola di RNA prodotta riconosca in ma-niera molto specifica la sequenza del RNA prodotta dal virus in modo da crearne una copia perfetta-mente complementare che rende quindi impossibile la formazione della proteina. Fin dalla sua scoperta, che valse il premio Nobel per la medicina a Craig Cameron Mello e An-drew Fire, l'RNAi ha catturato l'attenzione dei ri-cercatori per le sue potenzialità innanzitutto come possibile veicolo di medicinali per terapia genica, ma successivamente anche in tanti altri campi di applicazione, inclusa l'agricoltura. Relativamente alla difesa fitosanitaria, la prima applicazione commerciale è stata ottenuta dalla Monsanto (ora Bayer) e riguarda la produzione di un mais geneticamente modificato (denominato (Connua a pagina 11)
This paper considers the statistical analysis of entomological count data from field experiments ... more This paper considers the statistical analysis of entomological count data from field experiments with genetically modified (GM) plants. Such trials are carried out to assess environmental safety. Potential effects on nontarget organisms (NTOs), as indicators of biodiversity, are investigated. The European Food Safety Authority (EFSA) gives broad guidance on the environmental risk assessment (ERA) of GM plants. Field experiments must contain suitable comparator crops as a benchmark for the assessment of designated endpoints. In this paper, a detailed protocol is proposed to perform data analysis for the purpose of assessing environmental safety. The protocol includes the specification of a list of endpoints and their hierarchical relations, the specification of intended levels of data analysis, and the specification of provisional limits of concern to decide on the need for further investigation. The protocol emphasizes a graphical representation of estimates and confidence intervals for the ratio of mean abundances for the GM plant and its comparator crop. Interpretation relies mainly on equivalence testing in which confidence intervals are compared with the limits of concern. The proposed methodology is illustrated with entomological count data resulting from multiyear, multilocation field trials. A cisgenically modified potato line (with enhanced resistance to late blight disease) was compared to the original conventional potato variety in the Netherlands and Ireland in two successive years (2013, 2014). It is shown that the protocol encompasses alternative schemes for safety assessment resulting from different research questions and/or expert choices. Graphical displays of equivalence testing at several hierarchical levels and their interpretation are presented for one of these schemes. The proposed approaches should be of help in the ERA of GM or other novel plants.
The yield of several commodity crops is provided in large part by genetically modified crops in N... more The yield of several commodity crops is provided in large part by genetically modified crops in North and South America. However, reservations exist in Europe due to possible negative effects on human health or environment. This paper aims to analyse the current research priorities identified in EU countries and to engage European stakeholders into the formulation of future common research needs regarding the effects of the possible adoption of commercially available and forthcoming genetically modified organisms (GMOs) in the areas of socio-economics, human and animal health, and environment. Additionally, it aims to identify the requirements for sharing available research capacities and existing infrastructures. First a mapping exercise of existing research activities in Europe was performed. A questionnaire was developed on a web-based platform and submitted to national focal points to collect information from EU Member States. Information was collected from 320 research projects conducted in the last 10 years in Europe. To refine results of the surveys, twenty invited experts and stake-holders from the public funding agencies of different EU Member States participated in an international workshop. This paper reports the main findings of these activities.
Insect–plant interactions may be unintentionally affected when introducing genetically modified (... more Insect–plant interactions may be unintentionally affected when introducing genetically modified (GM) crops into an agro-ecosystem. Our aim was to test the non-target effects of a late blight-resistant GM potato on Myzus per-sicae in greenhouse and climate room experiments and understand how position and number of R gene insertions can affect non-targets in GM events. We also aimed to compare results to baseline differences among three conventional potato varieties varying in resistance to late blight. Aphid development and survival were affected by some GM events in the first generation, though effects disappeared in the second generation. Effects were not dependent on the presence of a marker gene or the insertion of a second resistance gene. Positional effects of gene insertion influenced aphid performance on certain GM events. However, aphid fitness varied considerably more between conventional potato varieties than between Désirée and the GM events. Comparing different GM events to the non-transformed variety is relevant, since unintended effects of insertion can occur. Our protocols can be recommended for in planta risk assessments with aphids. Ecological perspective is gained by selecting several measured endpoints and by comparing the results with a baseline of conventional cultivars. • We investigated the hypothesis that characteristics of a GM potato may influence the non-target aphid Myzus persicae. • Aphid performance was affected by the resistance gene position but not by the number of resistance genes or the presence of an antibiotic resistance marker gene. • Aphid performance varied considerably more between conventional cultivars than between the unmodified and the GM potato. • These findings support future protocols for risk assessments of GM crops on non-target insects.
This document provides guidance for the environmental risk assessment (ERA) of genetically modifi... more This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six steps for the ERA of GM plants, as indicated in Directive 2001/18/EC, starting with (1) problem formulation including hazard identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The scientific Panel on Genetically Modified Organisms (of the European Food Safety Authority (EFSA GMO Panel) considers seven specific areas of concern to be addressed by applicants and risk assessors during the ERA (1) persistence and invasiveness of the GM plant , or its compatible relatives, including plant-to-plant gene transfer ; (2) plant-to-microorganism gene transfer; (3) interaction of the GM plant with target organisms and (4) interaction of the GM plant with non-target organisms, including criteria for selection of appropriate species and relevant functional groups for risk assessment; (5) impact of the specific cultivation, management and harvesting techniques; including consideration of the production systems and the receiving environment(s); (6) effects on biogeochemical processes; and (7) effects on human and animal health. Each specific area of concern is considered in a structured and systematic way following the above-mentioned steps (1 to 6). In addition, the guidance document is supplemented with several general cross-cutting considerations (e.g. choice of comparator, receiving environment(s), general statistical principles, long-term effects) that need to be considered in the ERA.
The European Food Safety Authority (EFSA) asked the Panel on Genetically Modified Organisms to es... more The European Food Safety Authority (EFSA) asked the Panel on Genetically Modified Organisms to establish a self-tasking Working Group with the aim of (1) producing a scientific review of the current guidance of the GMO Panel for Environmental Risk Assessment (ERA), focusing on the potential impacts of GM plants on Non-Target Organisms (NTOs), (2) proposing criteria for NTOs selection, and (3) providing advise on standardized testing methodology. This initiative was undertaken in response to a need and request from a wide range of stakeholders, including the European Commission and Member States. In first instance, the self-tasking Working Group on Non-Target Organisms (EFSA NTO WG) mainly considered impacts of GM plants on invertebrate species, but also took account of ecosystem functions that could be altered. The EFSA NTO WG considered the necessity for clear and objective protection goals, for which assessment and measurement endpoints shall be developed; the need to initiate the scientific risk assessment by setting testable hypotheses; criteria for appropriate selection of test species and ecological functional groups; appropriate laboratory and field studies to collect relevant NTO data; and the use of statistical techniques that should be an integral part of experimental design. The EFSA NTO WG considered the range of approaches and methodologies of ERA of NTOs as described in the current literature and proposed risk assessment approaches based on selection of functional groups and individual species within a tiered approach. The present scientific opinion provides guidance to risk assessors for assessing potential effects of GM plants on NTOs, together with rationale for data requirements in order to complete a comprehensive ERA for NTOs. In this respect, guidance to applicants as outlined in the present opinion has been inserted in the updated Guidance Document of the EFSA GMO Panel for the ERA of GM plants. Zwahlen for the preparatory work on this scientific opinion, and EFSA staff: Sylvie Mestdagh for the support provided to this scientific opinion. In addition the Panel wishes to thank the three external referees, including Sue Hartley and Gabor Lövei, for reviewing an early draft of the document during its development phase, as well as Toby Bruce and Joop van Loon for providing technical input.
GM-crops and their potential environmental
risks are still controversial in the
EU.
• Earthworms ... more GM-crops and their potential environmental risks are still controversial in the EU. • Earthworms are important non-target organisms in arable soils. • Focal species are selected based on literature data following a four-step procedure. • Selection highly representative for EU biogeographical regions under maize or potato. • Selected focal species are recommended for testing based on life-history traits.
Ladybird beetles (Coleoptera Coccinellidae) are important predators of aphids and other crop pest... more Ladybird beetles (Coleoptera Coccinellidae) are important predators of aphids and other crop pests, and there is great interest in their conservation in agroecosystems. Bt-maize, genetically engineered to express insecticidal Cry proteins, is regarded as a taxon-specific way of controlling pests, but some concerns have been raised about the possibility of unintended negative effects on non-target organisms, including coccinellids. One of the possible routes of exposure of ladybird beetles to Cry toxins is by feeding on maize pollen, as for many species pollen is an important integrative food source. In this study, coccinellid adults were sampled by sweep netting in Ecological Compensation Areas (ECAs) in three sites of Northern and Central Italy, where conventional maize cultivars are grown (Bt-maize is currently forbidden for commercial cultivation in Italy). The coccinellid communities were sampled during and around the typical flowering periods of maize in order to check their diversity and their overlap with pollen shedding. A total of 11 species were recorded. Hippodamia variegata (Goeze), Coccinella septempunctata L. and the exotic Harmonia axyridis (Pallas) were the most abundant species in Northern Italy, whereas Tytthaspis sedecimpunctata (L.) and Coccinula quatuordecimpustulata (L.) were dominant in Central Italy. The potential exposure to maize pollen was different in the two areas, since in Northern Italy the maize flowering coincided with a period of high coccinellid activity in the field, whereas in Central Italy the ladybird population peaks occurred roughly one month earlier than the anthesis. The collected data might be useful for exposure characterization of ladybird beetles in a possible future scenario of Bt-maize cropping in the studied areas.
L’esigenza di protezione dei siti di importanza comunitaria dovrebbe tener conto anche dei possib... more L’esigenza di protezione dei siti di importanza comunitaria dovrebbe tener conto anche dei possibili impatti ambientali delle attività agricole eseguite nelle aree protette o contigue ad esse. Il progetto MAN-GMP-ITA (Validation of risk management tools for genetically modified plants in protected and sensitive areas in Italy) è finalizzato alla valutazione dei rischi di una eventuale coltivazione di piante geneticamente modificate (PGM) per aree protette e sensibili (www.man-gmp-ita.sinanet.isprambiente.it). Il progetto, finanziato dalla Commissione Europea nell’ambito del programma LIFE+, è stato sviluppato in aree protette di Emilia-Romagna, Lazio, Basilicata, Puglia e Sicilia, con il coordinamento di ENEA - C. R. Trisaia e la collaborazione di CRA-RPS (Roma), ISPRA (Roma), Università degli Studi di Bologna e Università degli Studi di Palermo. L’attività di ricerca svolta si propone di: individuare alcuni obiettivi di protezione specifici per aree protette o sensibili prossime ad aree agricole; selezionare schemi di monitoraggio ed indicatori ambientali per la gestione dell’impatto ambientale di PGM; validare una metodologia per il monitoraggio e la gestione di possibili effetti di PGM sulla biodiversità. Preliminare ad ogni valutazione del rischio di impatto ambientale è la conoscenza dell’ ambiente ricevente per poter stabilire degli obiettivi di protezione specifici; nelle aree protette italiane, spesso tale conoscenza è limitata rendendo difficile l’individuazione di tali obiettivi di protezione. Questa rassegna tende a supportare il lavoro dei gestori dell’area protetta SIC IT 9220090 “Costa Jonica - Foce Bradano” per la corretta gestione dei possibili rischi ambientali nell’area protetta, derivanti da attività antropiche e non soltanto quelle legate al settore agricolo. Il formato della pubblicazione intende poi specificamente offrire un contributo per la valorizzazione dell’area ed una fruizione da parte del pubblico per scopi conoscitivi ed estetici.
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process. Such differences might in some cases affect non-target organisms linked to the crop into an agro-ecosystem.
In this paper, we aimed to study interactions of two blight-resistant GM potato clones with the aphid species Macrosiphum
euphorbiae Thomas, a non-target arthropod frequently feeding on potato plants and one of the major pests of that crop. One of
the potato events used in our experiments caused an increased fertility of the aphids in the first generation, and consequently,
a positive effect on the growth of the aphid population was estimated. When a second generation of the aphid was reared on
potato leaves of the same GM event, differences in aphid fertility were no longer observed. Behavioural studies conducted
in a wind tunnel using the aphid parasitoid Aphidius ervi Haliday indicated that neither of the two tested GM varieties had a
significant effect on the attractiveness of potato plants towards the parasitoid. In planta tests proved to be sensitive protocols to
detect unintended effects on a non-target arthropod; experimental results, however, indicate that these effects are not expected
to be biologically relevant in this tritrophic system, if these GM events become available for commercial use in the future.
during their premarket phase. One of the areas of concern is the possible impact on nontarget
organisms. Crops expressing Cry toxins might affect Lepidoptera larvae living outside
cultivated fields, through pollen deposition on wild plants, which constitute their food
source. While pollen toxicity varies among different events, possible exposure of nontarget
species depends on the agro-environmental conditions. This study was conducted in two
protected areas in Italy, characterized by different climatic conditions, where many Lepidoptera
species thrive in proximity to maize cultivations. To estimate the possible exposure
in absence of the actual stressor (e.g., Cry1-expressing maize plants), we conducted a
two-year field survey of butterflies and weeds. Indicator species were selected—Aglais
(Inachis) io in the Northern site and Vanessa cardui in the Southern site—and their phenology
was investigated. Pollen dispersal from maize fields was measured by collection
in Petri dishes. Duration and frequency of exposure was defined by the overlap between
pollen emission and presence of larvae on host plants. Different risk scenarios are expected
in the two regions: highest exposure is foreseen for A. io in the Northern site, while minimal
exposure is estimated for V. cardui in the Southern site. In the latter case, locally grown
maize cultivars flower in mid-summer in coincidence with an aestivation period for several
butterfly species due to hot and dry conditions. Moreover, host plants of V. cardui are at
the end of their life cycle thus limiting food availability.
risks are still controversial in the
EU.
• Earthworms are important non-target
organisms in arable soils.
• Focal species are selected based on
literature data following a four-step
procedure.
• Selection highly representative for EU
biogeographical regions under maize
or potato.
• Selected focal species are recommended
for testing based on life-history traits.
process. Such differences might in some cases affect non-target organisms linked to the crop into an agro-ecosystem.
In this paper, we aimed to study interactions of two blight-resistant GM potato clones with the aphid species Macrosiphum
euphorbiae Thomas, a non-target arthropod frequently feeding on potato plants and one of the major pests of that crop. One of
the potato events used in our experiments caused an increased fertility of the aphids in the first generation, and consequently,
a positive effect on the growth of the aphid population was estimated. When a second generation of the aphid was reared on
potato leaves of the same GM event, differences in aphid fertility were no longer observed. Behavioural studies conducted
in a wind tunnel using the aphid parasitoid Aphidius ervi Haliday indicated that neither of the two tested GM varieties had a
significant effect on the attractiveness of potato plants towards the parasitoid. In planta tests proved to be sensitive protocols to
detect unintended effects on a non-target arthropod; experimental results, however, indicate that these effects are not expected
to be biologically relevant in this tritrophic system, if these GM events become available for commercial use in the future.
during their premarket phase. One of the areas of concern is the possible impact on nontarget
organisms. Crops expressing Cry toxins might affect Lepidoptera larvae living outside
cultivated fields, through pollen deposition on wild plants, which constitute their food
source. While pollen toxicity varies among different events, possible exposure of nontarget
species depends on the agro-environmental conditions. This study was conducted in two
protected areas in Italy, characterized by different climatic conditions, where many Lepidoptera
species thrive in proximity to maize cultivations. To estimate the possible exposure
in absence of the actual stressor (e.g., Cry1-expressing maize plants), we conducted a
two-year field survey of butterflies and weeds. Indicator species were selected—Aglais
(Inachis) io in the Northern site and Vanessa cardui in the Southern site—and their phenology
was investigated. Pollen dispersal from maize fields was measured by collection
in Petri dishes. Duration and frequency of exposure was defined by the overlap between
pollen emission and presence of larvae on host plants. Different risk scenarios are expected
in the two regions: highest exposure is foreseen for A. io in the Northern site, while minimal
exposure is estimated for V. cardui in the Southern site. In the latter case, locally grown
maize cultivars flower in mid-summer in coincidence with an aestivation period for several
butterfly species due to hot and dry conditions. Moreover, host plants of V. cardui are at
the end of their life cycle thus limiting food availability.
risks are still controversial in the
EU.
• Earthworms are important non-target
organisms in arable soils.
• Focal species are selected based on
literature data following a four-step
procedure.
• Selection highly representative for EU
biogeographical regions under maize
or potato.
• Selected focal species are recommended
for testing based on life-history traits.