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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.

Resource type: Adobe Acrobat (.pdf)

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

Publication date: 26/11/2018

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)

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

Publication date: 21/11/2018

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

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

Publication date: 16/08/2018

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)

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

Publication date: 06/08/2018

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.

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A critical juncture for synthetic biology

Publication date: 12/06/2018

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

Risk in synthetic biology – views from the lab

Publication date: 01/06/2018

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)

A global observatory for gene editing

Publication date: 21/03/2018

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

Rethink public engagement for gene editing

Publication date: 12/03/2018

Over the past three years, thousands of articles have been published about editing genes and genomes. Apart from a public dialogue run by the Royal Society at the end of last year, there’s been little attempt to engage the public on the implications of the technology in a way that could alter the decisions of scientists and policymakers. Indeed, concern about the lack of effective public engagement has motivated several workshops, including one by the intergovernmental Organisation for Economic Co-operation and Development (OECD).

If the history of public engagement surrounding other recent scientific innovations is a guide, efforts to explain the science behind gene editing will intensify, such as through news stories, at science festivals, in public lectures and in museums. And there will be a rash of small, disconnected workshops involving members of the public that are designed to inform specific policy decisions.

If this is all that happens, scientists and policymakers will be ill prepared for the public debate that will almost certainly erupt as applications proliferate.

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Resource type: article: Web Page

Potential high-frequency off-target mutagenesis induced by CRISPR/ Cas9 in Arabidopsis and its prevention

Publication date: 23/02/2018

This study reports that CRISPR/Cas9 can cause unexpectedly high off-target mutations in Arabidopsis, even when guide RNAs are predicted to be highly specific, with these effects worsening in later generations. To address this, researchers developed strategies to reduce off-target effects, including an mCherry-based system for selecting Cas9-free mutants and the use of high-specificity SpCas9 variants. They found that fusing tRNA with a mutant sgRNA scaffold greatly improved editing efficiency, though high-specificity Cas9 variants required stronger expression to match wild-type efficiency. The study also revealed that T-DNA integrates frequently at CRISPR/Cas9 cleavage sites, underscoring the need for continued monitoring of off-target effects and offering optimized tools for more precise genome editing in plants.

Resource type: article: Web Page