Limits of Concern: suggestions for the operationalisation of a concept to determine the relevance of adverse effects in the ERA of GMOs

Dolezel, Marion; Miklau, Marianne; Heissenberger, Andreas; Reichenbecher, Wolfram

doi:10.1186/s12302-018-0169-6

Cited by 5 publications

(2 citation statements)

References 96 publications

(159 reference statements)

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“…Genetically modified organisms and genetic engineering have generated a large debate on how to regulate the spread of modified genes in nature through hybridization e.g., ref. 72 . Genomic alteration for economic purposes may induce higher fertility and resistance to pathogens that make crops or hybrids highly invasive 73 .…”

Section: Box 2 | Hybridization and Human Evolutionmentioning

confidence: 99%

Harmonizing hybridization dissonance in conservation

2020

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A dramatic increase in the hybridization between historically allopatric species has been induced by human activities. However, the notion of hybridization seems to lack consistency in two respects. On the one hand, it is inconsistent with the biological species concept, which does not allow for interbreeding between species, and on the other hand, it is considered either as an evolutionary process leading to the emergence of new biodiversity or as a cause of biodiversity loss, with conservation implications. In the first case, we argue that conservation biology should avoid the discussion around the species concept and delimit priorities of conservation units based on the impact on biodiversity if taxa are lost. In the second case, we show that this is not a paradox but an intrinsic property of hybridization, which should be considered in conservation programmes. We propose a novel view of conservation guidelines, in which human-induced hybridization may also be a tool to enhance the likelihood of adaptation to changing environmental conditions or to increase the genetic diversity of taxa affected by inbreeding depression. The conservation guidelines presented here represent a guide for the development of programmes aimed at protecting biodiversity as a dynamic evolutionary system. B iodiversity is in crisis and the main reasons are human activities inducing habitat modifications and the introduction of invasive species 1. In addition, global climate change will probably alter habitat characteristics, migration patterns, reproduction time, and place of various species 2. Such human disturbances may produce new breeding overlaps, breaking the independent evolution of organisms and leading to hybridization (see Glossary, Table 1) 3. The role of hybridization in the evolution of several plant and animal taxa has been recognized in the light of newly developed molecular tools 4. This has also alerted biologists about the threat this phenomenon may represent to biodiversity when enhanced by anthropogenic factors 5. We identified three types of hybridization regarding the reproductive properties of first-generation

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Section: Box 2 | Hybridization and Human Evolutionmentioning

confidence: 99%

Harmonizing hybridization dissonance in conservation

2020

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“…55 Limits of concern are defined in EFSA (2013) as the minimum ecological effects that are deemed biologically relevant and that are deemed of sufficient magnitude to cause harm. These limits of concern are set for each assessment endpoint in the problem formulation (see also Dolezel et al, 2017Dolezel et al, , 2018). 56 A pathway to harm is a causal chain of events that need to occur for a harm to be realised.…”

Section: Devising Plausible Pathways To Harmmentioning

confidence: 99%

Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post‐market environmental monitoring of genetically modified insects containing engineered gene drives

Naegeli¹,

Bresson²,

Dalmay³

et al. 2020

EFS2

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Advances in molecular and synthetic biology are enabling the engineering of gene drives in insects for disease vector/pest control. Engineered gene drives (that bias their own inheritance) can be designed either to suppress interbreeding target populations or modify them with a new genotype. Depending on the engineered gene drive system, theoretically, a genetic modification of interest could spread through target populations and persist indefinitely, or be restricted in its spread or persistence. While research on engineered gene drives and their applications in insects is advancing at a fast pace, it will take several years for technological developments to move to practical applications for deliberate release into the environment. Some gene drive modified insects (GDMIs) have been tested experimentally in the laboratory, but none has been assessed in small-scale confined field trials or in open release trials as yet. There is concern that the deliberate release of GDMIs in the environment may have possible irreversible and unintended consequences. As a proactive measure, the European Food Safety Authority (EFSA) has been requested by the European Commission to review whether its previously published guidelines for the risk assessment of genetically modified animals (EFSA, 2012 and 2013), including insects (GMIs), are adequate and sufficient for GDMIs, primarily disease vectors, agricultural pests and invasive species, for deliberate release into the environment. Under this mandate, EFSA was not requested to develop risk assessment guidelines for GDMIs. In this Scientific Opinion, the Panel on Genetically Modified Organisms (GMO) concludes that EFSA's guidelines are adequate, but insufficient for the molecular characterisation (MC), environmental risk assessment (ERA) and post-market environmental monitoring (PMEM) of GDMIs. While the MC, ERA and PMEM of GDMIs can build on the existing risk assessment framework for GMIs that do not contain engineered gene drives, there are specific areas where further guidance is needed for GDMIs.

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Hypothesis-Led Ecological Risk Assessment of GM Crops to Support Decision-Making About Product Use

Raybould

2020

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

Cited by 5 publications

References 96 publications

Harmonizing hybridization dissonance in conservation

Harmonizing hybridization dissonance in conservation

Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post‐market environmental monitoring of genetically modified insects containing engineered gene drives

Hypothesis-Led Ecological Risk Assessment of GM Crops to Support Decision-Making About Product Use

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