The question whether new genetic modification techniques (nGM) in plant development might result in non-negligible negative effects for the environment and/or health is significant for the discussion concerning their regulation. However, current knowledge to address this issue is limited for most nGMs, particularly for recently developed nGMs, like genome editing, and their newly emerging variations, e.g., base editing. This leads to uncertainties regarding the risk/safety-status of plants which are developed with a broad range of different nGMs, especially genome editing, and other nGMs such as cisgenesis, transgrafting, haploid induction or reverse breeding. A literature survey was conducted to identify plants developed by nGMs which are relevant for future agricultural use. Such nGM plants were analyzed for hazards associated either (i) with their developed traits and their use or (ii) with unintended changes resulting from the nGMs or other methods applied during breeding. Several traits are likely to become particularly relevant in the future for nGM plants, namely herbicide resistance (HR), resistance to different plant pathogens as well as modified composition, morphology, fitness (e.g., increased resistance to cold/frost, drought, or salinity) or modified reproductive characteristics. Some traits such as resistance to certain herbicides are already known from existing GM crops and their previous assessments identified issues of concern and/or risks, such as the development of herbicide resistant weeds. Other traits in nGM plants are novel; meaning they are not present in agricultural plants currently cultivated with a history of safe use, and their underlying physiological mechanisms are not yet sufficiently elucidated. Characteristics of some genome editing applications, e.g., the small extent of genomic sequence change and their higher targeting efficiency, i.e., precision, cannot be considered an indication of safety per se, especially in relation to novel traits created by such modifications. All nGMs considered here can result in unintended changes of different types and frequencies. However, the rapid development of nGM plants can compromise the detection and elimination of unintended effects. Thus, a case-specific premarket risk assessment should be conducted for nGM plants, including an appropriate molecular characterization to identify unintended changes and/or confirm the absence of unwanted transgenic sequences.
Purpose:The prevailing controversies on the potential environmental risks of genetically modified organisms [GMOs] still fuel ongoing discussions among European Union [EU] member states, risk assessors, applicants and scientists, even several years after the commercial introduction of GMOs. The disagreements mainly derive from the current risk assessment practice of GMOs and differences in the perceived environmental risks. Against this background, the aim of this study was to scrutinize the current practice of environmental risk assessment [ERA] of several GMO applications currently pending for authorisation in the EU. Methods: We analysed the data presented for three assessment categories of the ERA of genetically modified [GM] maize applications for cultivation in the European Union: the agronomic evaluations and the assessments of the effects of GM maize on target organisms and of its potential adverse effects on non-target organisms.Results: Major shortcomings causing considerable uncertainties related to the risk assessment were identified in all three categories. In addition, two principles of Directive 2001/18/EC are largely not fulfilled -the consideration of the receiving environment and the indirect effects, as mediated, e.g. by the application of the complementary herbicide in the case of herbicide-tolerant GM maize. Conclusions:We conclude that the current practice of ERA does not comprehensively fulfil the scientific and legal requirements of Directive 2001/18/EC, and we propose improvements and needs for further guidance and development of standards. The recommendations address likewise applicants, risk assessors as well as decision makers.
BackgroundThe European Food Safety Authority (EFSA) has introduced a concept for the environmental risk assessment of genetically modified (GM) plants which foresees the definition of ecological threshold values defining acceptable adverse effects of the GM plant on the environment (Limits of Concern, LoC).MethodsWe analysed the LoC concept by scrutinising its feasibility with regard to important aspects of the environmental risk assessment. We then considered its relationship with protection goals, the comparative safety assessment and the stepwise testing approach. We finally discussed its usefulness for assessing long-term effects, effects on non-target organisms and species of conservation concern.ResultsThe LoC concept is a possible approach to introduce ecological thresholds into environmental risk assessment in order to evaluate environmental harm. However, the concept leaves many important aspects open. Thresholds for environmental harm for protection goals need spatial and temporal differentiation from LoCs used for ERA indicators. Regionalisation of LoCs must be provided for as biodiversity levels and protection goals vary across the EU. Further guidance is needed with respect to the consequences, in case LoCs are exceeded and a link needs to be established between environmentally relevant results from the comparative safety assessment and the LoC concept. LoCs for long-term effects have to be evaluated by long-term monitoring. LoCs for non-target organisms need to be discriminated according to the species and parameters assessed.ConclusionsThe overall LoC concept is considered useful if LoCs are further specified and differentiated. Although LoCs will finally be determined by political decisions, they should be based on scientific grounds in order to increase confidence in the conclusions on the safety of GM plants.
BackgroundThe European Food Safety Authority proposed a concept for the environmental risk assessment of genetically modified plants in the EU that is based on the definition of thresholds for the acceptability of potential adverse effects on the environment. This concept, called Limits of Concern (LoC), needs to be further refined to be implemented in the environmental risk assessment of genetically modified organisms.MethodsWe analyse and discuss how LoC can be defined for the environmental risk assessment for three different types of genetically modified plants. We outline protection goals relevant to the genetically modified plants in question and discuss existing concepts and suggestions for acceptability thresholds from the environmental risk assessment of different regulatory areas. We make specific recommendations for the setting and use of LoC for each type of genetically modified plant.ResultsThe LoC concept can be suitably applied for the environmental risk assessment of genetically modified organisms, if the different protection goals in agro-environments are specifically considered. Not only biodiversity protection goals but also agricultural protection goals need to be addressed. The different ecosystem services provided by weeds inside and outside agricultural fields have to be considered for genetically modified herbicide-tolerant crops. Exposure-based LoCs are suggested based on knowledge about dose–effect relationships between maize pollen and non-target Lepidoptera for insect-resistant maize. Due to the long-term nature of biological processes such as spread and establishment, LoCs for genetically modified oilseed rape should be defined for the presence of the genetically modified plant or its genetically modified traits in relevant protection goals.ConclusionsWhen setting LoCs, the focus should be on protection goals which are possibly affected. Potential overlaps of the LoC concept with the ecosystem service concept have to be clarified to harmonise protection levels in the agro-environment for different stressors. If additional impacts on agro-biodiversity resulting from the cultivation of genetically modified plants are to be avoided, then high protection levels and low thresholds for acceptable effects (i.e. LoC) should be set.
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