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A perspective from the EU: unintended genetic changes in plants caused by NGT—their relevance for a comprehensive molecular characterisation and risk assessment

Franziska Koller, Michael Cieslak

Publication date: 27/10/2023

The review concludes that unintended genetic changes caused by NGT processes are relevant to risk assessment. Due to the technical characteristics of NGTs, the sites of the unintended changes, their genomic context and their frequency (in regard to specific sites) mean that the resulting gene combinations (intended or unintended) may be unlikely to occur with conventional methods. This, in turn, implies that the biological effects (phenotypes) can also be different and may cause risks to health and the environment. Therefore, we conclude that the assessment of intended as well as unintended genetic changes should be part of a mandatory comprehensive molecular characterisation and risk assessment of NGT plants that are meant for environmental releases or for market authorisation.

Resource type: article: Web Page

FarmingLegislation & RegulationSustainability

The EU legislative framework for a sustainable food system: How can it effectively deliver for the environment and people?

Client Earth

Publication date: 08/09/2023

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In its Farm to Fork Strategy, the European Commission announced that it will present a legislative framework for a sustainable food system, an initiative expected for the third quarter of 2023.

The vision reflected in the law proposal will have a critical impact on the EU’s capacity to build its resilience against the worsening climate and biodiversity crises while guaranteeing long-term accessibility to healthy food.

The briefing presents solutions in the form of actionable tools that can best ensure the swift implementation of a sustainable EU food system on the ground. The European Commission must go ahead with its proposal and publish it in September 2023; there is no better time.

Resource type: article: Web Page

Legislation & RegulationScience & Technology

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

Franziska Koller, Meike Schulz, Matthias Juhas, Andreas Bauer-Panskus, Christoph Then

Publication date: 20/04/2023

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This review discusses the potential environmental and health risks associated with new genomic techniques (NGTs), which create novel genotypes and traits beyond those produced by conventional breeding or earlier genetic engineering methods. It highlights that large-scale releases of multiple NGT organisms—across species and traits—could lead to interactions and cumulative effects that exceed the risks of individual modifications. The authors argue that risk assessments must account for these combined and indirect effects, not just single events, and recommend a precautionary, prospective technology assessment to guide regulators in limiting release scales and minimizing unintended interactions in the environment.

Resource type: article: Web Page

FarmingLegislation & RegulationScience & Technology

Beyond the Genome: Genetically Modified Crops in Africa and the Implications for Genome Editing

Joeva Sean Rock, Matthew A. Schnurr, Ann Kingiri, Dominic Glover, Glenn Davis Stone, Adrian Ely, Klara Fischer

Publication date: 01/01/2023

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This article makes two interventions. First, it identifies the discursive continuity linking genome editing and the earlier technology of genetic modification. Second, it offers a suite of recommendations regarding how lessons learned from GM crops might be integrated into future breeding programmes focused on genome editing. Ultimately, the authors argue that donors, policymakers and scientists should move beyond the genome towards systems-level thinking by prioritizing the co-development of technologies with farmers; using plant material that is unencumbered by intellectual property restrictions and therefore accessible to resource-poor farmers; and acknowledging that seeds are components of complex and dynamic agroecological production systems. If these lessons are not heeded, genome-editing projects are in danger of repeating mistakes of the past

Resource type: article: Web Page

Legislation & RegulationPlant & Animal BreedingScience & Technology

Unintended Genomic Outcomes in Current and Next Generation GM Techniques: A Systematic Review

Philomena Chu, Sarah Zanon Agapito-Tenfen

Publication date: 07/11/2022

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This review examines studies on unintended genetic alterations caused by traditional and modern genetic modification techniques, including Agrobacterium-mediated transfer, biolistic bombardment, and CRISPR-Cas9 (delivered by various methods). Findings show that these techniques can produce a wide range of unintended genomic changes—from small mutations to major structural variations like chromosome truncations and large DNA rearrangements. Only a few studies used whole-genome or long-read sequencing, suggesting many such effects may be underestimated. The authors emphasize the need for improved analytical methods to better detect and assess these unintended modifications, helping regulators evaluate the safety of genetically modified and gene-edited organisms.

Resource type: article: Web Page

Citizen StakeholdersLegislation & RegulationSustainability

With great power comes great responsibility: why ‘safe enough’ is not good enough in debates on new gene technologies

Sigfrid Kjeldaas, Tim Dassler, Trine Antonsen, Odd-Gunnar Wikmark & Anne I. Myhr

Publication date: 25/10/2022

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To avoid past mistakes of under- or miscommunication about possible impacts, we need open, transparent, and inclusive societal debate on the nature of the science of gene (editing) technologies, on how to use them, and whether they contribute to sustainable solutions to societal and environmental challenges. To be trustworthy, GMO regulation must demonstrate the authorities’ ability to manage the scientific, socio-economic, environmental, and ethical complexities and uncertainties associated with NGTs. Regulators and authorities should give equal attention to the reflexive and the emotional aspects of trust and make room for honest public and stakeholder inclusion processes.

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ConservationLegislation & RegulationPlant & Animal BreedingSustainability

Genetic engineering, nature conservation and biological diversity: boundaries of design

German Federal Agency for Nature Conservation

Publication date: 01/10/2022

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Germany’s Federal Agency for Nature Conservation (BfN) presents its position on an international discussion surrounding research approaches to the genetic modification of wild organisms. Conclusions include:

Due to the complexity of biological diversity – from the molecular to the ecosystem level – the effects of genetically engineering wild organisms cannot be sufficiently assessed with the methods currently available.
The fundamental and necessary discussions on the compatibility of genetically engineering wild organisms with the requirements and the objectives laid down in section 1 of the German Federal Nature Conservation Act must be conducted.
Global biodiversity loss is progressing with tangible consequences. We need suitable instruments to stop it. Nevertheless, wild organisms must not be genetically modified solely based on the assumption of a potential benefit to nature conservation and with uncertainty about possible harm.
Along with its diversity, beauty and utility, nature’s uniqueness is a protected good in nature conservation that is firmly embedded in society and in legislation. Its intrinsic value imposes limits on the extent to which humans can intervene in nature to protect it. I

Resource type: Adobe Acrobat (.pdf)

Citizen StakeholdersConservationLegislation & RegulationSustainability

The principles driving gene drives for conservation

Sarah Hartley, Riley Taitingfong, Pedro Fidelman

Publication date: 01/09/2022

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Scientists are exploring potential gene drive applications for managing invasive species and building resilience in keystone species threatened by climate change. The possibility to use gene drive for these conservation purposes has triggered significant interest in how to govern its development and eventual applications. We conducted qualitative documentary analysis to examine the range and substance of principles emerging in the governance of conservation gene drive. Such analysis aimed to better understand the aspirations guiding these applications and how scientists and other experts imagine their responsibility in this field. We found a collection of recommendations and prescriptions that could be organised into a set of seven emerging principles intended to shape the governance of gene drive in conservation: broad and empowered engagement; public acceptance; decision-making informed by broad ranging considerations, state and international collaboration; ethical frameworks; diverse expertise; and responsible self-regulation by developers. We lay bare these emergent principles, analyzing the way in which they are valued, prioritized, and their strengths and weaknesses.

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Citizen StakeholdersLegislation & RegulationPlant & Animal BreedingSustainability

Imagined futures for livestock gene editing: Public engagement in the Netherlands

Senna Middelveld, Phil Macnaghten, Franck Meijboom

Publication date: 01/08/2022

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While gene editing is commonly represented as offering unbounded possibilities and societal benefit, it remains unclear how to characterise public views and the process through which responses are developed. Rather than simply being about individual attitudes, beliefs or preferences, we explicate an interpretative approach that seeks to understand how people make sense of the technology in the form of shared cultural idioms and stories. Based on five anticipatory focus group discussions with Dutch publics, we found the prevalence of five narratives shaping public talk, namely, technological fix, the market rules, in pursuit of perfection, finding the golden mean and governance through care. We explore the implications of these findings for governance and reflect on the virtues of sophrosyne and phronesis as offering ways to reconfigure the practice and politics of gene editing.

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Citizen StakeholdersLegislation & RegulationScience & TechnologySustainability

The complexity of the gene and the precision of CRISPR: What is the gene that is being edited?

Esha Shah, David Ludwig, Phil Macnaghten

Publication date: 26/10/2021

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This article argues that the polarization around the governance of gene editing partly reflects a failure of public engagement with the current state of research in genomics and postgenomics. CRISPR-based gene-editing technology has become embedded in a narrow narrative about the ease and precision of the technique that presents the gene as a stable object under technological control. This narrative fails to position the “ease of CRISPR-based editing” into the wider context of the “complexity of the gene.” While this strategic narrowness of CRISPR narratives aims to create public support for gene-editing technologies, we argue that it stands in the way of socially desirable anticipatory governance and open public dialogue about societal promises and the unintended consequences of gene editing. In addressing the polarization surrounding CRISPR-based editing technology, the article emphasizes the need for engagement with the complex state of postgenomic science that avoids strategic simplifications of the scientific literature in promoting or opposing the commercial use of the gene-editing technology.

Resource type: article: Web Page