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, 30 (1), 39

Limits of Concern: Suggestions for the Operationalisation of a Concept to Determine the Relevance of Adverse Effects in the ERA of GMOs

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Limits of Concern: Suggestions for the Operationalisation of a Concept to Determine the Relevance of Adverse Effects in the ERA of GMOs

Marion Dolezel et al. Environ Sci Eur.

Abstract

Background: The 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.

Methods: We 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.

Results: The 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.

Conclusions: When 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.

Keywords: Environmental risk assessment; GMO; Genetically modified plants; Limits of Concern.

Figures

Fig. 1
Fig. 1
Options for setting LoCs for genetically modified plants. modified after [10]
Fig. 2
Fig. 2
Acceptability of natural processes due to GM oilseed rape cultivation in agricultural and non-agricultural areas. The natural processes are cross-pollination, spread and establishment and hybridisation. Red boxes = agricultural and biodiversity protection goals for which the natural processes may represent unacceptable impacts. Green boxes = species and agricultural or natural habitats for which natural processes may represent acceptable impacts
Fig. 3
Fig. 3
Suggestions for the operationalisation of the LoC concept for non-target lepidopteran larvae and Bt maize. The LoC can be defined for the exposure-based indicators (a) “amount of Bt maize pollen released” or (b) “amount of Bt maize pollen deposited” in a specific environmental reference area (e.g. the field margin). For further explanation see text

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References

    1. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. OJ L 106:1–39
    1. Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. OJ L 268:1–23
    1. Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006. OJ L 157:1–48
    1. Commission Decision of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. (notified under document number C(2002) 2715) (2002/623/EC) OJ L 200:22–33
    1. Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms. OJ L 67:30–45

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