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.
In November 2010, the Panel on Genetically Modified Organisms (GMO Panel) of the European Food Sa... more In November 2010, the Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) issued a Scientific Opinion (SO) that delivers guidance on the environmental risk assessment (ERA) of genetically modified (GM) plants. Beside the ERA SO, the EFSA GMO Panel developed a separate SO that provides specific guidance for the evaluation of potential adverse effects of GM plants on non-target organisms (NTOs). This paper describes some elements of the ERA SO and NTO SO pertaining to NTO risk assessment, with a focus on: (1) problem formulation; (2) protection goals and limits of concern; (3) intended and unintended effects; (4) species selection for testing purposes; and (5) stacked transformation events. Some scientific comments from EU Member States and stakeholders received during the development of both documents through public consultations are also presented.
engl.), New EU legislation on environmental liability is likely to limit damage to biodiversity, ... more engl.), New EU legislation on environmental liability is likely to limit damage to biodiversity, soil and water, but all three components within certain limits. Since ecology as science is seeking insight into the interaction between biotic and abiotic components, the term 'ecological' damage has to deal with hazards on the interaction level. A hazard is the potential of a risk source to cause an adverse effect. Risk assessment can be defined as a process of evaluation including the identification of the attendant uncertainties, of the likelihood and severity of an adverse effect(s) /event(s) occurring to man or the environment following exposure under defined conditions to a risk source(s). The sequential steps in risk assessment of Genetically Modified Organisms (GMO): identify characteristics which may cause adverse effects, evaluate their potential consequence, assess the likelihood of occurrence and estimate the risk posed by each identified characteristic of the GMO. E...
Genes of Bacillus thuringiensis var. kurstaki (Berliner) that encode lepidopteran-specific toxins... more Genes of Bacillus thuringiensis var. kurstaki (Berliner) that encode lepidopteran-specific toxins were engineered into maize for protection against the European Corn Borer, Ostrinia nubilalis (Hbn.). Recent data suggest that Lepidoptera may be negatively affected, if maize pollen contains high amounts of Bt toxin and is diposited on host plants near maize fields. Monitoring the environmental effects of commercial Bt maize fields requires effective use of limited financial and logistical resources. The aim of this study was to develop and apply tools for selecting relevant herbivore species for the field monitoring of environmental Bt toxin effects via pollen deposition. We first present a theoretical selection tree based on "risk index of Bt pollen for herbivores" (I(Btp)). Our index consists of five classes from zero (not relevant) to four (highly relevant) derived from data on potential temporal and spatial coincidence of pollen exposure (A), feeding mode (B), susceptibi...
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.
In November 2010, the Panel on Genetically Modified Organisms (GMO Panel) of the European Food Sa... more In November 2010, the Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) issued a Scientific Opinion (SO) that delivers guidance on the environmental risk assessment (ERA) of genetically modified (GM) plants. Beside the ERA SO, the EFSA GMO Panel developed a separate SO that provides specific guidance for the evaluation of potential adverse effects of GM plants on non-target organisms (NTOs). This paper describes some elements of the ERA SO and NTO SO pertaining to NTO risk assessment, with a focus on: (1) problem formulation; (2) protection goals and limits of concern; (3) intended and unintended effects; (4) species selection for testing purposes; and (5) stacked transformation events. Some scientific comments from EU Member States and stakeholders received during the development of both documents through public consultations are also presented.
engl.), New EU legislation on environmental liability is likely to limit damage to biodiversity, ... more engl.), New EU legislation on environmental liability is likely to limit damage to biodiversity, soil and water, but all three components within certain limits. Since ecology as science is seeking insight into the interaction between biotic and abiotic components, the term 'ecological' damage has to deal with hazards on the interaction level. A hazard is the potential of a risk source to cause an adverse effect. Risk assessment can be defined as a process of evaluation including the identification of the attendant uncertainties, of the likelihood and severity of an adverse effect(s) /event(s) occurring to man or the environment following exposure under defined conditions to a risk source(s). The sequential steps in risk assessment of Genetically Modified Organisms (GMO): identify characteristics which may cause adverse effects, evaluate their potential consequence, assess the likelihood of occurrence and estimate the risk posed by each identified characteristic of the GMO. E...
Genes of Bacillus thuringiensis var. kurstaki (Berliner) that encode lepidopteran-specific toxins... more Genes of Bacillus thuringiensis var. kurstaki (Berliner) that encode lepidopteran-specific toxins were engineered into maize for protection against the European Corn Borer, Ostrinia nubilalis (Hbn.). Recent data suggest that Lepidoptera may be negatively affected, if maize pollen contains high amounts of Bt toxin and is diposited on host plants near maize fields. Monitoring the environmental effects of commercial Bt maize fields requires effective use of limited financial and logistical resources. The aim of this study was to develop and apply tools for selecting relevant herbivore species for the field monitoring of environmental Bt toxin effects via pollen deposition. We first present a theoretical selection tree based on "risk index of Bt pollen for herbivores" (I(Btp)). Our index consists of five classes from zero (not relevant) to four (highly relevant) derived from data on potential temporal and spatial coincidence of pollen exposure (A), feeding mode (B), susceptibi...
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