Regulation of Genome Editing in Plant Biotechnology: European Union

Voigt, Brigitte; Münichsdorfer, Ansgar

doi:10.1007/978-3-030-17119-3_5

Cited by 6 publications

(3 citation statements)

References 131 publications

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“…Even GM crop-importing countries are beginning to clarify their policy positions regarding GEd crops, with, for example, the Japanese Consumer Affairs Agency confirming that GEd food products will not require risk assessments and that GM foods would and will enter the market without labels [70]. New Zealand has adopted a similar regulatory strategy to the EU, firmly articulating that all GEd crop varieties will be regulated as equivalent to GM crops [68]. In August 2019, the Council of the European Union requested the European Commission submit a study by April 2021 on the EU's options for addressing the challenges of trying to regulate GEd varieties using the existing regulatory system [20].…”

Section: Implications For the Regulation Of Gene-edited Cropsmentioning

confidence: 99%

Socio-Economic Considerations and Potential Implications for Gene-Edited Crops

Ludlow

Smyth

Falck-Zepeda

2021

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Regulatory clarity and efficiency are increasingly important for the successful commercialization of technologies resulting from public and private R&D investments. This article examines recent developments in the movement away from mostly science-based risk assessment regulatory and variety approval systems focusing on human and animal health and environmental safety to hybrid systems that include assessment of socio-economic considerations allowed for under the auspices of the Cartagena Protocol on Biosafety. We propose that socio-economic consideration assessments can be grouped into three methodological categories: empirically based, legally grounded and consensus approaches. Our exploration of developments in the three categories reveals gaps in data, consistency and methodology rigor, that must be addressed for efficient and reliable socio-economic consideration assessment. We assess the potential impacts of these gaps on the regulation of gene-edited crop varieties, concluding that if gene-edited crops are regulated as genetically modified crops, they will endure the same fate, that is, lengthy regulatory approval processes and failure to be commercialized. The end result being that the regulatory burdens in potential adopting and food insecure countries will prevent important new crop varieties from reaching farmers and producers for their use. https://doi.org/10.21423/jrs-v09i2ludlow

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Section: Implications For the Regulation Of Gene-edited Cropsmentioning

confidence: 99%

Socio-Economic Considerations and Potential Implications for Gene-Edited Crops

Ludlow

Smyth

Falck-Zepeda

2021

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“…In most jurisdictions globally, GMOs are regulated as products of their "transformation event" (Holst-Jensen et al, 2006;Lezaun, 2006;OECD, 2006;Voigt and Münichsdorfer, 2019). The concept is based on transgenic technology that relies on random genomic integration of the transgene into the genome (see Figure 1A), whereby the same transgene is inserted at different genomic loci that can produce different phenotypes via insertional mutagenesis or differential levels of transgene expression, sometimes referred to as "position effects" (Nolan et al, 2002;Alonso et al, 2003;Gong et al, 2005;Kim and Gelvin, 2007;Phuc et al, 2007).…”

Section: Introductionmentioning

confidence: 99%

Defining transformation events for gene drive in species complexes

Connolly

2023

Preprint

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Engineered gene drives (EGDs) that allow the super-Mendelian inheritance of genetic traits could one day be used to reduce the vectorial capacity of Anopheles species that transµit huµan µalaria in Africa. Many Anopheles species belong to coµplexes of closely related sibling species that can produce fertile interspecific hybrid feµales. In cases where the genoµic target locus of the EGD is conserved aµongst sibling species froµ the saµe coµplex as the released target species, it would therefore be plausible that the EGD could be vertically transµitted froµ the target species to sibling species by interspecific µating. To differentiate genetically µodified organisµs, the terµ ‘transforµation event’ is used, based on the specific genoµic location of the transgenic construct, as a result of randoµ genoµic integration. In contrast, an EGD is generated via its precise and reproducible insertion in its specific genoµic target locus. These considerations pose two key questions for the use of EGD in species coµplexes: (i) what does the definition of “transforµation event” µean in the context of vertical gene drive transfer of the EGD to sibling species in species coµplexes and (ii) does de novo transforµation of an EGD into a sibling species constitute the saµe transforµation event as introgression by backcrossing into a sibling species of an EGD that had been originally transforµed in the target species? While definitions of the terµ transforµation event that have been provided by national and intergovernµental organisations are soµewhat aµbiguous, they do provide scope for broad interpretation of vertical gene drive transfer of a specific EGD to different sibling species of the target species as the saµe transforµation event. There also appears to be soµe consensus that definitions of transforµation event support the notion that de novo transforµations of an EGD in sibling species constitute the saµe transforµation events as introgression by backcrossing into sibling species of an EGD that had been originally inserted in the target species.

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“…However, the regulations are still stringent in Europe where all organisms that have undergone the process of mutagenesis and harbour a genome that cannot naturally occur are regulated as GMOs. However, an exemption to this is the classical, random mutagenesis techniques that has been conventionally used to develop mutant crop varieties [590]. This declaration from the European Court of Justice has been a burden on biotech industries using the CRISPR systems to market their products as it requires additional permissions and labelling adding up to the nancial cost [591].…”

Section: Random Mutagenesis; An Alternative To Targeted Engineering In Nannochloropsismentioning

confidence: 99%

A “CRISPY” tale on microalgal genome editing: featuring Nannochloropsis oceanica IMET1

Naduthodi

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CHAPTER 1 General Introduction CHAPTER 2 Progress of CRISPR-Cas based genome editing in photosynthetic microbes CHAPTER 3 CRISPR-Cas ribonucleoprotein mediated homology-directed repair for e cient targeted genome editing in microalgae Nannochloropsis oceanica IMET1 CHAPTER 4 A comprehensive genome engineering toolbox for microalgae Nannochloropsis oceanica based on CRISPR-Cas systems CHAPTER 5 High-throughput insertional mutagenesis reveals novel targets for enhancing lipid accumulation in Nannochloropsis oceanica CHAPTER 6 Heterologous expression of EPA speci c Lysophosphatidic acid acyltransferase in Nannochloropsis oceanica increases the EPA content in Triglycerides CHAPTER 7 Synthetic biology approaches to enhance microalgal productivity CHAPTER 8 General Discussion References

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Regulation of Genome Editing in Plant Biotechnology: European Union

Cited by 6 publications

References 131 publications

Socio-Economic Considerations and Potential Implications for Gene-Edited Crops

Socio-Economic Considerations and Potential Implications for Gene-Edited Crops

Defining transformation events for gene drive in species complexes

A “CRISPY” tale on microalgal genome editing: featuring Nannochloropsis oceanica IMET1

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