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31.07.2018 |

Repair of double-strand breaks induced by CRISPR–Cas9 leads to large deletions and complex rearrangements

Abstract

CRISPR–Cas9 is poised to become the gene editing tool of choice in clinical contexts. Thus far, exploration of Cas9-induced genetic alterations has been limited to the immediate vicinity of the target site and distal off-target sequences, leading to the conclusion that CRISPR–Cas9 was reasonably specific. Here we report significant on-target mutagenesis, such as large deletions and more complex genomic rearrangements at the targeted sites in mouse embryonic stem cells, mouse hematopoietic progenitors and a human differentiated cell line. Using long-read sequencing and long-range PCR genotyping, we show that DNA breaks introduced by single-guide RNA/Cas9 frequently resolved into deletions extending over many kilobases. Furthermore, lesions distal to the cut site and crossover events were identified. The observed genomic damage in mitotically active cells caused by CRISPR–Cas9 editing may have pathogenic consequences.

27.07.2018 |

Communities Raise Their Voices on Genetic Engineering

Crispr technology may allow scientists to change the environment forever, but working with the affected localities presents a challenge.

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Crispr, which stands for clustered regularly interspaced short palindromic repeats, isn’t the first new technology to pose such complicated questions. But Crispr offers “the potential to control evolution and change future species,” says biochemist Kevin Esvelt, an assistant professor at the Cambridge, Mass.-based MIT Media Lab, where Mice Against Ticks was born.

Crispr is the immune system of bacteria. Scientists adapted Crispr and the Cas9 enzyme that it produces to serve as a tool to edit DNA in plants, animals and humans. Researchers soon realized that Crispr might be used not only to edit or repair genes of people living with diseases but also to edit embryos, changing the DNA of future generations. It could also be used to create a so-called “gene drive,” spreading engineered genetic changes through populations of wild animals but also altering the environment in unpredictable ways. With so much at stake, Dr. Esvelt says, scientists must not make such decisions by themselves.

25.07.2018 |

Industry shocked by EU Court decision to put gene editing technique under GM law

The European Court of Justice ruled on Wednesday (25 July) that organisms obtained by mutagenesis plant breeding technique are GMOs and should, in principle, fall under the GMO Directive, in a surprising move that went contrary to the Advocate-General’s non-binding opinion.

The decision shocked the industry, which described it as a severe blow to innovation in EU agriculture and warned about economic and environmental consequences.

József Máté, Corporate Communications Leader at Corteva Agriscience, described the Court decision as a “bad day” for the EU agri-food sector.

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A ‘victory’

On the contrary, it was warmly welcomed by environmental NGOs, who said the EU shut the door to “new GMOs”. They hailed the Court’s decision and called it a victory for consumers, farmers and the environment.

Nina Holland, a campaigner from the Corporate Europe Observatory, said big agribusiness corporations will continue lobbying in Brussels to escape EU safety rules for the new GMOs.

“But today’s ruling leaves no doubt: Products from gene editing are covered by the existing EU GMO rules,” she said.

Similarly, Bart Staes MEP [Greens/EFA] noted that just because the industry has come up with new ways to modify organisms “does not mean that these techniques should be exempt from existing EU standards on GMOs.”

“Recent scientific studies show that these new techniques might not be as accurate as the industry claims them to be, that’s why it’s essential that they come under the same labelling requirements and impact assessments as existing GMOs,” he added.

25.07.2018 |

ECJ rules in favour of tough regulation for new GM techniques

UK umbrella campaign GM Freeze today welcomed a European Court of Justice (ECJ) decision to ensure proper regulation of controversial new genetic engineering techniques.

Supporting the position taken by environmental campaigners, the judgement states that organisms obtained by mutagenesis are Genetically Modified Organisms (GMOs). In addition, it states clearly that the only techniques that can escape full GMO regulation are those that already had a history of safe use in 2001.

25.07.2018 |

A victory for food safety and the environment: ECJ ruling on new GMOs

Today, the European Court of Justice ruled that organisms obtained by mutagenesis, otherwise known as "new breeding techniques" by the biotech industry, are in fact Genetically Modified Organisms (GMOs), and are subject to the 2001 EU GMO Directive and all its obligations. Despite heavy lobbying by the industry looking for ways to circumvent the GMO Directive, the Court's ruling is a victory for European food safety and the environment.

Bart Staes MEP, Greens/EFA group in the European Parliament and spokesperson on GMOs comments:

"Today's ruling is a victory for food safety and the environment. Just because the industry has come up with new ways to modify organisms does not mean that these techniques should be exempt from existing EU standards on GMOs. Recent scientific studies show that these new techniques might not be as accurate as the industry claims them to be, that's why it's essential that they come under the same labelling requirements and impact assessments as existing GMOs. These new patented organisms may have unintended effects, as well the potential to increase our dependence on the agri-chemical industry, and therefore must be stringently monitored by the European Food Safety Authority for any risks to human, animal and environmental health."

25.07.2018 |

Campaign groups demand action as Rothamsted Research GM field trial is ruled unlawful

GM Freeze and GeneWatch UK have today written to Environment Secretary Michael Gove, to demand the immediate halt of an unlawful trial of gene edited plants at Rothamsted Research. The trial of genetically modified (GM) Camelina sativa, includes some plants which have been genetically modified using new gene editing techniques. These plants did not go through the required legal process of an environmental risk assessment and public consultation.

Environmental and consumer organisations have repeatedly pointed out that gene edited plants and animals are covered by regulations for genetically modified organisms (GMOs), which require environmental risk assessments, food safety assessments and traceability and labelling of products. These important legal requirements are designed to protect human health and the environment and to allow consumers to choose to avoid GM foods, should they wish to do so. However, the field trial at Rothamsted was allowed to go ahead based on incorrect advice that these important safeguards were unnecessary. Today, a ruling from the European Court of Justice confirmed that GMO regulations do in fact apply to gene edited crops.

The organisations call for the current trial to end immediately and for any future trials to follow the legal requirements for GMOs.

25.07.2018 |

EU's top court confirms safety checks needed for new 'GMO 2.0'

The EU's top court ruled today that a controversial new generation of food genetic engineering techniques should be subject to EU safety checks and consumer labelling.

In a landmark ruling, the European Court of Justice confirmed that new techniques to modify genetic material in plant or animal cells – so called 'GMO 2.0' – must undergo the same safety checks for their impacts on the environment and human health as existing genetically modified foods (GMOs).

Mute Schimpf, food and farming campaigner at Friends of the Earth Europe said: "These new 'GMO 2.0' genetic engineering techniques must be fully tested before they are let out in the countryside and into our food. We welcome this landmark ruling which defeats the biotech industry's latest attempt to push unwanted genetically-modified products onto our fields and plates."

The biotech industry has been arguing that GMO 2.0 foods and crops should not go through existing EU safety and labelling laws. Today's decision therefore preserves the EU's food safety and traceability standards, which would have been threatened by any ambiguity in the ruling.

Mute Schimpf continued: "EU and national lawmakers now need to ensure that all new genetically modified products are fully tested, and they must also support the small-scale, nature-friendly agriculture we urgently need."

25.07.2018 |

New GMOs cannot escape testing and labelling under EU law, EU court rules

Brussels – A new brand of genetically modified organisms (GMOs), derived from so-called gene editing techniques, must comply with risk assessment, traceability and labelling requirements under EU GMO law, the European Court of Justice ruled on Wednesday.

The Court said that any organism obtained with new genetic engineering techniques falls within the scope of GMO law. It argued that the risks linked to the use of these techniques are comparable to those associated with conventional genetic engineering.

The ruling confirms warnings by scientists who have argued that gene editing can cause unintended DNA damage with unknown consequences. A recent article in Nature showed that CRISPR/Cas can cause much greater genetic deletions and more complex genomic rearrangements than experts thought.

Greenpeace EU food policy director Franziska Achterberg said: “The Court makes it crystal clear that plants and animals derived from gene editing are subject to the same safety and labelling requirements as other GM organisms. These requirements exist to prevent harm and inform consumers about the food they eat. Releasing these new GMOs into the environment without proper safety measures is illegal and irresponsible, particularly given that gene editing can lead to unintended side effects. The European Commission and European governments must now ensure that all new GMOs are fully tested and labelled, and that any field trials are brought under GMO rules.”

25.07.2018 |

ECJ ruling on gene editing products: Victory for consumers, farmers, environment

The European Court of Justice (ECJ) today published its ruling on the legal status of food and feed crops derived from certain new genetic modification techniques. It gave clear confirmation that organisms from these new gene editing techniques are covered by existing EU GMO regulation.

Reacting to the decision, which corroborates the January 2018 opinion of one of the court’s Advocates General, Corporate Europe Observatory’s agribusiness campaigner Nina Holland said:

“This is a big victory for the environment, farmers and consumers. It clarifies that EU decision makers have to ensure that products from these new techniques are assessed for potential food safety and environmental risks, and that they are properly labelled as GMOs.

“Big agribusiness corporations will continue their lobbying in Brussels to escape EU safety rules for the new GMOs, but today's ruling leaves no doubt: Products from gene editing are covered by the existing EU GMO rules.

"This ruling also means that the secret, unregulated field trial currently run in Belgium is illegal. The CRISPR-technique does in no way have a "history of safe use", and the plants used in this trial are undoubtedly GMOs. Belgian authorities should act accordingly and halt this trial."

25.07.2018 |

The judges of the EU Court of Justice
Court of Justice of the European Union

EU Court of Justice: CRISPR is genetic engineering

The European Court of Justice today has issued a long awaited verdict on the question how to interpret the exemption of certain forms of mutagenisis from the EU regulation on genetically modified organisms. Acoording to its press release today, the Court clearly states: All mutagenesis is genetic modfication. Therefore, some traditional forms of random mutagenesis (by radiation and chemical treatment) had been explicitely exempted from the regulation. This exemption, the court decided, does not apply to new forms of direct mutagenesis by new technologies of genetic engineering such as CRISPR-Cas.

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