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Plant & 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

Here, we systematically review the scientific literature for studies that have investigated unintended genomic alterations in plants modified by the following GM techniques: Agrobacterium tumefaciens-mediated gene transfer, biolistic bombardment, and CRISPR-Cas9 delivered via Agrobacterium-mediated gene transfer (DNA-based), biolistic bombardment (DNA-based) and as ribonucleoprotein complexes (RNPs). The results of our literature review show that the impact of such techniques in host genomes varies from small nucleotide polymorphisms to large genomic variation, such as segmental duplication, chromosome truncation, trisomy, chromothripsis, breakage fusion bridge, including large rearrangements of DNA vector-backbone sequences. We have also reviewed the type of analytical method applied to investigate the genomic alterations and found that only five articles used whole genome sequencing in their analysis methods. In addition, larger structural variations detected in some studies would not be possible without long-read sequencing strategies, which shows a potential underestimation of such effects in the literature. As new technologies are constantly evolving, a more thorough examination of prospective analytical methods should be conducted in the future.

Resource type: article: Web Page

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 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.

Resource type: article: Web Page

Plant & Animal BreedingScience & Technology

Mutation bias reflects natural selection in Arabidopsis thaliana

J. Grey Monroe, et al.

Publication date: 12/01/2022

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Researchers studying Arabidopsis thaliana found that mutations are not random but occur less often in essential and functionally important genes—about half as often within genes and two-thirds less in essential ones. Epigenomic and physical genome features explain over 90% of this variation, and these mutation patterns accurately predict natural genetic diversity. The results show that epigenome-linked mutation bias protects key genes, challenging the traditional view that mutation is a random, directionless process in evolution.

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Citizen StakeholdersLegislation & RegulationPlant & Animal BreedingSustainability

How to Do What Is Right, Not What Is Easy: Requirements for Assessment of Genome-Edited and Genetically Modified Organisms under Ethical Guidelines

T. Antonsen, T. Dassler

Publication date: 24/06/2021

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An ethical assessment is a complex, dynamic and comprehensive process that requires both ethical expertise and practical knowledge. An ethical assessment of a genetically modified organism (GMO, including genome edited organisms) must follow accepted and transparent methods and be based in relevant considerations. In addition, the Ethical guidelines must include a broad and adequate range of values, so that no groups, stakeholders, agents or areas are left out.

We recommend that ethical assessments of GMOs (including genome-edited organisms) are performed by professionals with competence and practical knowledge of ethical judgements, and that users, non-users, stakeholders and interest groups are actively involved. In addition, we recommend that the Ethical guidelines include a wide range of ethical values.

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Citizen StakeholdersLegislation & RegulationPlant & Animal BreedingScience & TechnologySustainability

Democratizing CRISPR? Stories, practices, and politics of science and governance on the agricultural gene editing frontier

Maywa Montenegro de Wit

Publication date: 25/02/2020

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Many trends in agricultural biotechnology have extended fluidly from the first era of genetic modification using recombinant DNA techniques to the era of gene editing. But the high-profile, explicit, and assertive discourse of democratization with gene editing — especially CRISPR-Cas9 — is something new.

In this paper, I draw on semi-structured interviews with gene editors, policy analysts, and communications experts as well as with critical academic and civil society experts. I use Science and Technology Studies and political ecology lenses to unpack democratization in three main parts.

First is democratizing discourses: On what grounds is CRISPR said to be democratic? Who is saying so? How do dissident communities respond to these narratives? Second is agricultural applications, with a focus on the Innovative Genomics Institute’s work in developing gene-edited food crops, including a case of saveable clonal hybrid rice. Third is governance, where I contrast US Department of Agriculture regulations and the CRISPRcon conference as “closed” and “invited” spaces, respectively, for democratic participation.

Next, I argue that “created spaces,” in which power is held by typically delegitimized actors and ideas, offer an opening for working out democracy on the terrain of biotechnology. I conclude with a set of principles and practices for CRISPR governance based on the idea that democratization of biotechnology requires epistemic justice. By gathering multiple, partial knowledges together, we move beyond narrow risk-benefit framings to better evaluate not just what CRISPR is and does, but what democracy means and whom it serves.

Resource type: Adobe Acrobat (.pdf)

Legislation & RegulationPlant & Animal BreedingScience & Technology

European science community urges rethink on genome editing

John Innes Centre and 126 research institutions

Publication date: 25/07/2019

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Scientists from the John Innes Centre and The Sainsbury Laboratory today joined colleagues from across Europe in calling for an urgent rethink of EU legislation on Genetically Modified Organisms (GMOs).

An open statement signed by 126 research institutes says that scientists and plant breeders in the European Union should be enabled to use gene editing with CRISPR as a faster and more efficient way of producing food sustainably.

Aimed at the newly-elected European Parliament and European Commission, the statement comes one year to the day that the European Court of Justice (ECJ) ruled that plants obtained by modern forms of mutagenesis, of which gene-editing is an example, are not exempted from the EU GMO Directive.

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Legislation & RegulationPlant & Animal Breeding

Roads forward for European GMO policy—uncertainties in wake of ECJ judgment have to be mitigated by regulatory reform

Wasmer M

Publication date: 05/06/2019

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This article gives an overview of legal and procedural uncertainties regarding genome edited organisms and possible ways forward for European GMO policy. After a recent judgment by the European Court of Justice (ECJ judgment of 25 July 2018, C-528/16), organisms obtained by techniques of genome editing are GMOs and subject to the same obligations as transgenic organisms.

Uncertainties emerge if genome edited organisms cannot be distinguished from organisms bred by conventional techniques, such as crossing or random mutagenesis. In this case, identical organisms can be subject to either GMO law or exempt from regulation because of the use of a technique that cannot be identified. Regulatory agencies might not be able to enforce GMO law for such cases in the long term. As other jurisdictions do not regulate such organisms as GMOs, accidental imports might occur and undermine European GMO regulation.

In the near future, the EU Commission as well as European and national regulatory agencies will decide on how to apply the updated interpretation of the law. In order to mitigate current legal and procedural uncertainties, a first step forward lies in updating all guidance documents to specifically address genome editing specifically address genome editing, including a solution for providing a unique identifier. In part, the authorization procedure for GMO release can be tailored to different types of organisms by making use of existing flexibilities in GMO law.

However, only an amendment to the regulations that govern the process of authorization for GMO release can substantially lower the burden for innovators. In a second step, any way forward has to aim at amending, supplementing or replacing the European GMO Directive (2001/18/EC). The policy options presented in this article presuppose political readiness for reform. This may not be realistic in the current political situation. However, if the problems of current GMO law are just ignored, European competitiveness and research in green biotechnology will suffer.

Resource type: Adobe Acrobat (.pdf)

Legislation & RegulationPlant & Animal BreedingScience & Technology

Gene Drives. A report on their science, applications, social aspects, ethics and regulations

Critical Scientists Switzerland (CSS), et al

Publication date: 29/05/2019

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This lengthy and in-depth report – a collaboration by Critical Scientists Switzerland (CSS), European Network of Scientists for Social and Environmental Responsibility (ENSSER) and Vereinigung Deutscher Wissenschaftler (VDW) – delves into the science, biology and techniques behind gene drives, their potential applications and risks, as well as the social, ethical legal and regulatory issues that the technology, perhaps inevitably, brings with it.

Resource type: Adobe Acrobat (.pdf)

Legislation & RegulationPlant & Animal Breeding

CRISPR editing of plants and animals gets green light in Australia. Now what?

Salleh, A

Publication date: 30/04/2019

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Changes will make Australian gene technology regulations more relaxed than New Zealand and Europe but tighter than the US. Some scientists urge caution and question the arguments used to support deregulation of the most common form of gene editing, but the food authority has yet to decide on safety assessment and labelling of gene-edited foods.

Resource type: article: Web Page