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

European Network of GMO Laboratories (ENGL)

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.

Resource type: Adobe Acrobat (.pdf)

Legislation & RegulationScience & Technology

Adopt a moratorium on heritable genome editing

Lander E et al

Publication date: 13/03/2019

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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.

Resource type: article: Web Page

Citizen StakeholdersPlant & Animal BreedingScience & Technology

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

Gelinsky E and Hilbeck A

Publication date: 20/12/2018

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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.

Resource type: Adobe Acrobat (.pdf)

Plant & Animal BreedingScience & Technology

Livestock 2.0 – genome editing for fitter, healthier, and more productive farmed animals

Tait-Burkard C, et al

Publication date: 26/11/2018

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The human population is growing, and as a result we need to produce more food whilst reducing the impact of farming on the environment. Selective breeding and genomic selection have had a transformational impact on livestock productivity, and now transgenic and genome-editing technologies offer exciting opportunities for the production of fitter, healthier and more-productive livestock. Here, we review recent progress in the application of genome editing to farmed animal species and discuss the potential impact on our ability to produce food.

Resource type: Adobe Acrobat (.pdf)

Plant & Animal BreedingScience & Technology

Bound to fail: The flawed scientific foundations of agricultural genetic engineering

Antoniou A

Publication date: 21/11/2018

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Many technologies, at the time of their inception, have appeared efficacious, safe, and generally a good idea, based on the science at the time. However, in a number of cases, a technology that was once deemed appropriate and desirable has later turned out to be not such a good idea after all. Not only has it failed to deliver on its promises, but it has given rise to environmental damage and negative health impacts. Such technologies have ended up being abandoned or tightly restricted.

There are many examples from history. Asbestos, DDT insecticides, leaded gasoline, and PCBs (polychlorinated biphenyls) in electrical goods were all once hailed as great innovations, but as we grew in our understanding of the mechanisms and complexities of nature’s functioning, we found they could have devastating effects on the health of humans and animals.

We continue to learn from our catastrophic mistakes, but only after serious damage has already occurred to health and the environment. In order to avoid such damage, we need to constantly review each technology from the perspective of the science from which it is derived. Transgenic and genome editing technologies are no exception.

Resource type: article: Web Page

Plant & Animal BreedingScience & Technology

What is the available evidence for the application of genome editing as a new tool for plant trait modification and the potential occurrence of associated off-target effects: a systematic map protocol

Modrzejewski D, et al

Publication date: 16/08/2018

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Plant breeding is a developing process and breeding methods have continuously evolved over time. In recent years, genome editing techniques such as clustered regularly interspaced short palindromic repeats/CRISPR associated proteins (CRISPR/Cas), transcription activator-like effector nucleases (TALENs), zinc-finger nucleases (ZFN), meganucleases (MN) and oligonucleotide-directed mutagenesis (ODM) enabled a precise modification of DNA sequences in plants. Genome editing has already been applied in a wide range of plant species due to its simplicity, time saving and cost-effective application compared to earlier breeding techniques including classical mutagenesis. Although genome editing techniques induce much less unintended modifications in the genome (off-target effects) compared to classical mutagenesis techniques, off-target effects are a prominent point of criticism as they might cause genomic instability, cytotoxicity and cell death.

Resource type: Adobe Acrobat (.pdf)

Science & Technology

Is the new European ruling on GM techniques ‘anti-science’?

Andy Stirling

Publication date: 06/08/2018

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There has been much commotion in the media over the past week, following the ruling by the European Court of Justice over how to interpret EU laws bearing on the regulation of GM crops.

The ruling clarifies an anomaly, in that new plant varieties developed by longstanding non-GM gene-altering techniques of ‘mutagenesis‘ (using chemical reactions or ionising radiation) are now interpreted “in principle” to be classifiable as GMOs. The new GM techniques of ‘gene editing‘, on the other hand, are interpreted by the ECJ to be included in existing GM regulations.

In a complex case, the Court’s rationale is not without some ambiguity or persisting questions.

Resource type: Web page URL

Citizen StakeholdersLegislation & RegulationScience & Technology

A critical juncture for synthetic biology

Benjamin D Trump et al

Publication date: 12/06/2018

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The development of new technologies and their applications often have to navigate regulatory limitations and public attitudes, expectations or resistance – the trajectories of genetically modified crops in the Europe or the success of in vitro fertilization after initial resistance demonstrate how public attitudes and regulation can determine if a technology succeeds or fails.

Academic scientists and companies working on new technologies increasingly must consider these factors and mitigate real and perceived risks of the technology so as to avoid overreaching regulation and public resistance that could threaten innovation. In this context, social science takes an important role by gauging public attitudes about if and how the emergence of new technologies stokes fears and raises hopes.

This article illustrates how the natural sciences and social sciences interacted in the emerging fields of synthetic biology and nanotechnology, specifically the timing and rise of social science research and commentary on the potential impact and risks of these emerging technologies.

Resource type: Web page URL

Legislation & RegulationScience & Technology

Risk in synthetic biology – views from the lab

Carmen McLeod et al

Publication date: 01/06/2018

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The concepts of risk and responsibility are often linked to discussions of emerging scientific fields, but studies into how these concepts are connected to research practices have been narrowly focused on risks for humans and the environment.

To broaden these concepts, “Responsible Research and Innovation” (RRI), a democratic governance framework, aims to enable societal discussions beyond traditional risk assessment and mitigation. Proponents of RRI argue that these discussions should not be confined to the direct risks of the research itself, but also include wider issues, such as “the purposes and motivations of research” [1]. Yet, it is not only RRI protagonists who want to broaden this conversation.

We found that scientists also ponder non‐technical risks, such as the impact of institutional demands on career, health and social relationships, or economic pressures from the incentive system in which much of research in biology is now embedded. These findings challenge the present formulation of RRI as a science governance framework and lead us to argue that “responsible” research and innovation systems can only succeed if these broader concerns are taken as seriously as the risk of laboratory accident or inadvertent release.

Resource type: Adobe Acrobat (.pdf)

Citizen StakeholdersLegislation & RegulationScience & Technology

A global observatory for gene editing

Sheila Jasanoff and J. Benjamin Hurlbut

Publication date: 21/03/2018

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In August 2017, scientists reported that they had used the gene-editing tool CRISPR–Cas9 to correct a mutation in viable human embryos. The work is just one of countless applications of the technique, with which scientists hope to alter plants, animals and humans.

The value of most applications of the technology has barely been exposed to public review. Unless these editorial aspirations are more inclusively debated, well-intentioned research could move humanity closer to a future it has not assented to and might not want.

Over the past three years, leading scientists have called for global deliberation on the possible effects of gene editing on the human future. In our view, the discussions that have taken place fall far short of the expansive, cosmopolitan conversation that is needed.

Free enquiry, the lifeblood of science, does not mean untrammelled freedom to do anything. Society’s unwritten contract with science guarantees scientific autonomy in exchange for a research enterprise that is in the service of, and calibrated to, society’s diverse conceptions of the good. As the dark histories of eugenics and abusive research on human subjects remind us, it is at our peril that we leave the human future to be adjudicated in biotechnology’s own “ecclesiastical courts”.

It is time to invite in voices and concerns that are currently inaudible to those in centres of biological innovation, and to draw on the full richness of humanity’s moral imagination. An international, interdisciplinary observatory would be an important step in this direction.

Resource type: article: Web Page