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

Publication date: 29/05/2019

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.

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

Publication date: 30/04/2019

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.

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New Possibilities on the Horizon: Genome Editing Makes the Whole Genome Accessible for Changes

Publication date: 24/04/2019

The emergence of new genome editing techniques, such as the site-directed nucleases, clustered regulatory interspaced short palindromic repeats (CRISPRs)/Cas9, transcription activator-like effector nucleases (TALENs), or zinc finger nucleases (ZFNs), has greatly increased the feasibility of introducing any desired changes into the genome of a target organism. The ability to target a Cas nuclease to DNA sequences with a single-guide RNA (sgRNA) has provided a dynamic tool for genome editing and is naturally derived from an adaptive immune system in bacteria and archaea. CRISPR/Cas systems are being rapidly improved and refined, thereby opening up even more possibilities. Classical plant breeding is based on genetic variations that occur naturally and is used to select plants with improved traits. Induced mutagenesis is used to enhance mutational frequency and accelerate this process. Plants have evolved cellular processes, including certain repair mechanisms that ensure DNA integrity and the maintenance of distinct DNA loci. The focus of this review is on the characterization of new potentials in plant breeding through the use of CRISPR/Cas systems that eliminate natural limitations in order to induce thus far unachievable genomic changes.

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Promises and perils of gene drives: Navigating the communication of complex, post-normal science

Publication date: 16/04/2019

In November of 2017, an interdisciplinary panel discussed the complexities of gene drive applications as part of the third Sackler Colloquium on “The Science of Science Communication.” The panel brought together a social scientist, life scientist, and journalist to discuss the issue from each of their unique perspectives. This paper builds on the ideas and conversations from the session to provide a more nuanced discussion about the context surrounding responsible communication and decision-making for cases of post-normal science. Deciding to use gene drives to control and suppress pests will involve more than a technical assessment of the risks involved, and responsible decision-making regarding their use will require concerted efforts from multiple actors. We provide a review of gene drives and their potential applications, as well as the role of journalists in communicating the extent of uncertainties around specific projects. We also discuss the roles of public opinion and online environments in public engagement with scientific processes. We conclude with specific recommendations about how to address current challenges and foster more effective communication and decision-making for complex, post-normal issues, such as gene drives.

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Detection of food and feed plant products obtained by new mutagenesis techniques

Publication date: 26/03/2019

The European Network of GMO Laboratories (ENGL) has reviewed the possibilities and challenges for the detection of food and feed plant products obtained by new directed mutagenesis techniques leading to genome editing.The focus of this report is on products of genome editing that do not contain any inserted recombinantDNA in the final plant.

It concludes that validation of an event-specific detection method and its implementation for market control will only be feasible for genome-edited plant products carrying a known DNA alteration that has been shown to be unique. Under the current circumstances, market control will fail to detect unknown genome-edited plant products.Several issues with regard to the detection, identification and quantification of genome-edited products are currently based on theoretical considerations only and lack any experimental evidence. Therefore,they will require further consideration.

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The ethics of genome editing in non-human animals: a systematic review of reasons reported in the academic literature

Publication date: 25/03/2019

In recent years, new genome editing technologies have emerged that can edit the genome of non-human animals with progressively increasing efficiency. Despite ongoing academic debate about the ethical implications of these technologies, no comprehensive overview of this debate exists. To address this gap in the literature, we conducted a systematic review of the reasons reported in the academic literature for and against the development and use of genome editing technologies in animals. Most included articles were written by academics from the biomedical or animal sciences. The reported reasons related to seven themes: human health, efficiency, risks and uncertainty, animal welfare, animal dignity, environmental considerations and public acceptability. Our findings illuminate several key considerations about the academic debate, including a low disciplinary diversity in the contributing academics, a scarcity of systematic comparisons of potential consequences of using these technologies, an underrepresentation of animal interests, and a disjunction between the public and academic debate on this topic. As such, this article can be considered a call for a broad range of academics to get increasingly involved in the discussion about genome editing, to incorporate animal interests and systematic comparisons, and to further discuss the aims and methods of public involvement.

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Adopt a moratorium on heritable genome editing

Publication date: 13/03/2019

We call for a global moratorium on all clinical uses of human germline editing — that is, changing heritable DNA (in sperm, eggs or embryos) to make genetically modified children.

By ‘global moratorium’, we do not mean a permanent ban. Rather, we call for the establishment of an international framework in which nations, while retaining the right to make their own decisions, voluntarily commit to not approve any use of clinical germline editing unless certain conditions are met.

To begin with, there should be a fixed period during which no clinical uses of germline editing whatsoever are allowed. As well as allowing for discussions about the technical, scientific, medical, societal, ethical and moral issues that must be considered before germline editing is permitted, this period would provide time to establish an international framework.

Thereafter, nations may choose to follow separate paths. About 30 nations currently have legislation that directly or indirectly bars all clinical uses of germline editing, and they might choose to continue the moratorium indefinitely or implement a permanent ban. However, any nation could also choose to allow specific applications of germline editing, provided that it first: gives public notice of its intention to consider the application and engages for a defined period in international consultation about the wisdom of doing so; determines through transparent evaluation that the application is justified; and ascertains that there is broad societal consensus in the nation about the appropriateness of the application. Nations might well choose different paths, but they would agree to proceed openly and with due respect to the opinions of humankind on an issue that will ultimately affect the entire species.

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Embracing uncertainty: what are the implications for sustainability and development?

Publication date: 23/01/2019

Uncertainties can make it hard to plan ahead. But recognising them can help to reveal new questions and choices. What kinds of uncertainty are there, why do they matter for sustainability, and what ideas, approaches and methods can help us to respond to them?

Uncertainty is a concept that defines our times. Every media headline seems to assert that things are uncertain, and increasingly so. Whether it’s climate change, disease outbreaks, economic conditions or political settlements, the same narrative exists.

Helga Nowotny, in her book The Cunning of Uncertainty, argues that “uncertainty is written into the script of life”. But how should we understand ‘uncertainty’, and why does it matter? Are we equipped for responding to seemingly accelerating uncertainties across different policy domains?

A conventional, managerial and technocratic approach is to construct such challenges as risks – where the probabilities of future outcomes are known, or at least can be estimated. The paraphernalia of risk assessment and management are familiar, derived from engineering approaches. These approaches are good for some cases, such as designing a bridge or road, but not for others, where complex socio-ecological dynamics are involved.

 

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Revisiting risk governance of GM plants: the need to consider new and emerging gene-editing techniques

Publication date: 21/12/2018

New and emerging gene-editing techniques make it possible to target specific genes in species with greater speed and specificity than previously possible. Of major relevance for plant breeding, regulators and scientists are discussing how to regulate products developed using these gene-editing techniques.

Such discussions include whether to adopt or adapt the current framework for GMO risk governance in evaluating the impacts of gene-edited plants, and derived products, on the environment, human and animal health and society. Product classification or definition is one of several aspects of the current framework being criticized. Further, knowledge gaps related to risk assessments of gene-edited organisms—for example of target and off-target effects of intervention in plant genomes—are also of concern.

Resolving these and related aspects of the current framework will involve addressing many subjective, value-laden positions, for example how to specify protection goals through ecosystem service approaches. A process informed by responsible research and innovation practices, involving a broader community of people, organizations, experts, and interest groups, could help scientists, regulators, and other stakeholders address these complex, value-laden concerns related to gene-editing of plants with and for society.

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European Court of Justice ruling regarding new genetic engineering methods scientifically justified: A commentary on the biased reporting about the recent ruling

Publication date: 20/12/2018

In July 2018, the European Court of Justice (Case C-528/16) ruled that organisms obtained by directed mutagenesis techniques are to be regarded as genetically modified organisms (GMOs) within the meaning of Directive 2001/18. The ruling marked the next round of the dispute around agricultural genetic engineering in Europe. Many of the pros and cons presented in this dispute are familiar from the debate around the first generation of genetic engineering techniques. The current wave of enthusiasm for the new genetic engineering methods, with its claim to make good on the failed promises of the previous wave, seems to point more to an admission of failure of the last generation of genetic engineering than to a true change of paradigm. Regulation is being portrayed as a ban on research and use, which is factually incorrect, and the judges of the European Court of Justice are being defamed as espousing “pseudoscience”. Furthermore, this highly polarised position dominates the media reporting of the new techniques and the court’s ruling. Advocates of the new genetic engineering techniques appear to believe that their benefits are so clear that furnishing reliable scientific evidence is unnecessary. Meanwhile, critics who believe that the institution of science is in a serious crisis are on the increase not just due to the cases of obvious documented scientific misconduct by companies and scientists, but also due to the approach of dividing the world into those categorically for or against genetic engineering. In this construct of irreconcilable opposites, differentiations fall by the wayside. This article is a response to this one-sided and biased reporting, which often has the appearance of spin and lacks journalistic ethics that require journalists to report on different positions in a balanced and factual manner instead of taking positions and becoming undeclared advocates themselves.

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