Evaluation of existing guidelines for their adequacy for the molecular characterisation and environmental risk assessment of genetically modified plants obtained through synthetic biology

Naegeli, Hanspeter; Bresson, Jean‐Louis; Dalmay, Tamás; Dewhurst, Ian Crawford; Epstein, Michelle M; Firbank, Leslie George; Guerche, Philippe; Hejátko, Jan; Moreno, F. Javier; Nogué, Fabien; Rostoks, Nils; Serrano, Jose Juan Sánchez; Savoini, G.; Veromann, Eve; Veronesi, F.; Casacuberta, Josep; Schrijver, Adinda De; Messéan, Antoine; Patron, Nicola J.; Zurbriggen, Matías D.; Álvarez, Fernando; Devos, Yann; Gennaro, Andrea; Streissl, Franz; Papadopoulou, Nikoletta; Mullins, Ewen

doi:10.2903/j.efsa.2021.6301

Cited by 16 publications

(66 citation statements)

References 24 publications

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“…We conclude that the assessment of some of these traits will be challenging. EFSA came to the same conclusion in their case study of a complex modified low-gluten wheat plant modified in multiple genes by a CRISPR/Cas-based method [27]. Such applications differ significantly from any plants which were assessed previously and would require a comprehensive approach for risk assessment including ERA and food/feed safety assessment.…”

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confidence: 82%

Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU

Eckerstorfer

Grabowski²,

Lener

et al. 2021

BioTech

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An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants.

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mentioning

confidence: 82%

Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU

Eckerstorfer

Grabowski²,

Lener

et al. 2021

BioTech

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“…Until now, there has been insufficient comprehensive analysis of the complexity of SDN-1 application types in market-oriented plant studies. This review reinvestigates market-oriented SDN-1 applications in crop plants derived from the dataset generated by Modrzejewski et al [57,58] and determines the proportion of three different SDN-1 application types. It firstly describes the criteria used by Modrzejewski and coworkers to generate the dataset of market-oriented applications in plants [13], and subsequently describes how these studies were assigned to three different categories of SDN-1 application types.…”

Section: Sdn-1 Application Types In Crop Plantsmentioning

confidence: 99%

“…CRISPR/Cas induced different alterations at each individual target site as indicated by different deletion or insertion types found at the target locus of the gRNA 'sgAlpha-2 (see Figure 1b and Figure 1c respectively in [81]). The same study was also listed as an example by the European Food Safety Authority (EFSA) in its recent scientific opinion on the 'Evaluation of existing guidelines for their adequacy for the molecular characterization and ERA of GM plants obtained through synthetic biology' regarding the analysis of complex alterations induced by CRISPR/Cas [57]. EFSA assigned the wheat with a decreased α-gliadin content to synthetic biology [57].…”

Section: Generic Process-based Risksmentioning

confidence: 99%

“…The same study was also listed as an example by the European Food Safety Authority (EFSA) in its recent scientific opinion on the 'Evaluation of existing guidelines for their adequacy for the molecular characterization and ERA of GM plants obtained through synthetic biology' regarding the analysis of complex alterations induced by CRISPR/Cas [57]. EFSA assigned the wheat with a decreased α-gliadin content to synthetic biology [57]. Synthetic biology is a more advanced form of genetic engineering with an increased depth of intervention.…”

Section: Generic Process-based Risksmentioning

confidence: 99%

“…Synthetic biology is a more advanced form of genetic engineering with an increased depth of intervention. According to EFSA, their case study shows that a strategy is needed to identify the type of alteration and position in each individual gene to prevent the accumulation of any unintended peptide fragments [57]. Such analyses are of major importance for risk assessment, especially when considering SDN-1 applications with a higher level of complexity and/or depth of intervention (see Section 3).…”

Section: Generic Process-based Risksmentioning

confidence: 99%

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The Generic Risks and the Potential of SDN-1 Applications in Crop Plants

Kawall¹

2021

Plants

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The use of site-directed nucleases (SDNs) in crop plants to alter market-oriented traits is expanding rapidly. At the same time, there is an on-going debate around the safety and regulation of crops altered with the site-directed nuclease 1 (SDN-1) technology. SDN-1 applications can be used to induce a variety of genetic alterations ranging from fairly ‘simple’ genetic alterations to complex changes in plant genomes using, for example, multiplexing approaches. The resulting plants can contain modified alleles and associated traits, which are either known or unknown in conventionally bred plants. The European Commission recently published a study on new genomic techniques suggesting an adaption of the current GMO legislation by emphasizing that targeted mutagenesis techniques can produce genomic alterations that can also be obtained by natural mutations or conventional breeding techniques. This review highlights the need for a case-specific risk assessment of crop plants derived from SDN-1 applications considering both the characteristics of the product and the process to ensure a high level of protection of human and animal health and the environment. The published literature on so-called market-oriented traits in crop plants altered with SDN-1 applications is analyzed here to determine the types of SDN-1 application in plants, and to reflect upon the complexity and the naturalness of such products. Furthermore, it demonstrates the potential of SDN-1 applications to induce complex alterations in plant genomes that are relevant to generic SDN-associated risks. In summary, it was found that nearly half of plants with so-called market-oriented traits contain complex genomic alterations induced by SDN-1 applications, which may also pose new types of risks. It further underscores the need for data on both the process and the end-product for a case-by-case risk assessment of plants derived from SDN-1 applications.

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The need for assessment of risks arising from interactions between NGT organisms from an EU perspective

Koller¹,

Schulz²,

Juhas³

et al. 2023

Environ Sci Eur

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Background New genomic techniques (NGTs) allow new genotypes and traits to be developed in different ways and with different outcomes compared to previous genetic engineering methods or conventional breeding (including non-targeted mutagenesis). EU GMO regulation requires an assessment of their direct and indirect effects that may be immediate, delayed or cumulative. Such effects may also result from the interactions of NGT organisms simultaneously present in a shared receiving environment or emerge from a combination of their traits. This review elaborates such potential interactions based on a literature review and reasoned scenarios to identify possible pathways to harm. Main findings NGT organisms might be introduced into the environment and food chains on a large-scale, involving many traits, across a broad range of species and within short periods of time. Unavoidably, this would increase the likelihood that direct or indirect effects will occur through interactions between NGT organisms that are, for example simultaneously present within a shared environment. It has to be assumed that the cumulative effects of these NGT organisms may exceed the sum of risks identified in the distinct ‘events’. Consequently, risk assessors and risk managers not only need to consider the risks associated with individual NGT organisms (‘events’), but should also take account of risks resulting from their potential interactions and combinatorial effects. In addition, a prospective technology assessment could help the risk manager in defining criteria to minimize potential unintended interactions between NGT organisms through limiting the scale of releases. Conclusions If genetically engineered (GE) organisms derived from NGTs are released into the environment, their potentially negative impacts need to be minimized. As with all GE organisms, it is, therefore, crucial to not only assess the risks of the individual events, but also their potential interactions which can trigger direct and indirect effects with adverse impacts. It is necessary to develop hypotheses and specific scenarios to explore interactions between NGT organisms and possible pathways to harm from the perspective of the precautionary principle. In addition, the introduction prospective technology assessment could provide an instrument for the risk manager to control the scale of releases of NGT organisms.

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Evaluation of existing guidelines for their adequacy for the molecular characterisation and environmental risk assessment of genetically modified plants obtained through synthetic biology

Cited by 16 publications

References 24 publications

Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU

Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU

The Generic Risks and the Potential of SDN-1 Applications in Crop Plants

The need for assessment of risks arising from interactions between NGT organisms from an EU perspective

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