Questionable Statement of Leopoldina and DFG on New GE

30 September 2020 / In a letter to the president of the German National Academy of Sciences Leopoldina, Prof. Dr. Gerald Haug, Testbiotech has raised some serious questions in relation to a virtual conference planned by Leopoldina and the German Research Foundation (DFG). The organisers plan to present a ‘Statement’ on new genetic engineering techniques (New GE, also called genome editing) and plant breeding during the conference. The authors of the ‘Statement’ claim that there are no specific risks associated with the application of genetic engineering in plant breeding and are demanding changes to EU GMO regulation. As a consequence, most genetically engineered organisms would no longer undergo mandatory risk assessment and approval process as requested by current EU regulation.

Imagine a world without natural enemies like parasites or deadly pathogens. Where crops grow unfettered by rodent and insect pests. Advances in genetic engineering now hold the possibility to alter genomes at the population level, but is it too good to be true? A critical review in the September 2020 issue of IEAM delves into environmental risk assessments for controversial gene drives in the European Union. Lead author Christoph Then talks with us about the challenges facing risk assessors of gene drives and a potential cut-off criteria presented in the study. Access the article in the September 2020 issue of IEAM.

New scientific paper demonstrates the need for process oriented risk assessment

Wednesday, 12 August 2020

A new scientific paper published in the Environmental Sciences Europe journal gives an overview of the risks associated with genome editing procedures (new genetic engineering) for plants and animals. The risks are not only restricted to a wide range of unintended effects that can be triggered by the process of genome editing. There are also risks associated with the intended biological characteristics generated through genome editing.

Genome editing techniques, in particular those using the CRISPR/Cas 'gene scissors', increase the possibilities and speed with which the genomes of plants and animals can be altered. It does not matter whether additional genes are introduced into the genome or not. Small genetic modifications are often performed in combination and can cause significant changes in metabolic pathways and plant composition. The study concludes that the novel, intended properties must be thoroughly tested, even if no additional genes are inserted.

Genome editing techniques, especially the CRISPR/Cas technology, increase the possibilities and the speed of altering genetic material in organisms. So-called genome editing is increasingly being used to achieve agriculturally relevant novel traits and/or genetic combinations in both plants and animals, although predominantly as proof of concept studies, with commercial growing or rearing so far limited to the U.S. and Canada. However, there are numerous reports of unintended effects such as off-target effects, unintended on-target effects and other unintended consequences arising from genome editing, summarised under the term genomic irregularities. Despite this, the searching for genomic irregularities is far from routine in these studies and protocols vary widely, particularly for off-target effects, leading to differences in the efficacy of detection of off-target effects.

The German Ministry of Agriculture has launched a study on the feasibility of detection methods for "new" genetic engineering (NGT) - two years after the European Court of Justice clarified that the same rules apply as for "old" genetic engineering. Results should not be available until 2022. Even then, there will be no detection method for the only relevant NGT plant so far.

Huge success for animal welfare coalition and environmental organisations

Thursday, 2 July 2020

The European Patent Office (EPO) has for ethical reasons now declared two patents on genetically engineered chimpanzees to be no longer valid. All claims on genetically engineered animals have to be removed from the patents concerned. The Technical Board of Appeal at the EPO decided in favour of oppositions and appeals filed by a broad coalition of animal welfare and environmental organisations. European patent law prohibits patents on the genetic engineering of animals if it is likely to cause animal suffering. Exceptions are only made if there is real evidence of substantial medical benefit. According to the EPO, no such benefit was shown. It is the first time that the EPO has interpreted this rule so strictly. The decision is also binding for other cases.

Petition for a ban on the release of gene drive organisms

Gene drive organisms are perhaps one of the most dangerous environmental applications of genetic engineering ever developed: Enabled by new genetic engineering techniques such as CRISPR/Cas9, the genetic make-up of living organisms can be fundamentally altered and the natural rules of heredity can be overridden. In this way, wild species can be genetically modified, replaced or even eradicated. Once released into nature, gene drive organisms would be irretrievable. Any field trial would potentially be highly risky. In the worst case scenario the release of gene drive organisms into nature could accelerate the extinction of species and lead to the collapse of entire ecosystems. We call on the German Federal Government, to use its EU Council Presidency in the second half of 2020, to bring about a Europe-wide ban on the release of gene drive organisms and to make good use of its role as the chief negotiator for the EU at the next Conference of the Parties to the UN Convention on Biological Diversity in October 2020 to prevent the first releases of gene drive organisms into nature.

Sign the petition!

Press release by Save Our Seeds / Zukunftsstiftung Landwirtschaft, Berlin – Germany

Gene Drive technology: Species extinction through genetic engineering?

78 organizations call on the European Commission to enact a temporary ban on the novel Gene Drive technology.

30. June 2020

In an open letter initiated by Greenpeace EU, Friends of the Earth Europe, IFOAM EU and the German initiative Save Our Seeds, 78 environmental, agricultural, animal welfare and development aid organisations from all over Europe are calling on the EUCommission to outlaw the release of so-called Gene Drive Organisms in the EU and internationally. With this new application of genetic engineering, entire animal populations and species in nature could be reprogrammed or eradicated.

Statements reveal scientific ignorance

A German Green faction wants to de-regulate gene editing (see article below from Euractiv.com). Clearly they have no idea of the scientific problems that are constantly unfolding with gene editing technologies, in the form of unintended on-target and off-target effects. These are summarised here. In the case of gene-edited foods and crops, these genetic errors could lead to unexpected toxicity or allergenicity.

One Green MEP states that “The current regulation is very contradictory,” on the grounds that that gene technologies such as CRISPR are used regularly in medical research but not for agriculture.

But it is dishonest and invalid to conflate the use of gene-editing technologies in the medical field with their use in agricultural biotech. In the medical field, all use of GMOs (including gene editing) must be "contained" – in other words, viable GMOs are not allowed to escape into the environment. And all medicines, GM or not, have to go through long and thorough safety tests before being allowed on the market – though we all know that even with those safeguards in place, much can still go wrong.

Potential applications encompass humans, animals, plants and many ecosystems

4 June 2020 / The number of projects aiming to genetically engineer microorganisms has increased strongly in recent years. More effective techniques of analysis and re-synthesis of gene sequences can now be used as starting point for seeking new markets for ‘SynBio’ organisms. Projects include microorganisms which, for example, colonise the gut of humans or bees, live on the surface or inside plants or are abundant in soils. In addition, there is further ongoing research into viruses, bacteria or microbial fungi known as pathogens, which can be developed for use in vaccines, pesticides or for the military. The risks are especially relevant if SynBio microorganisms are allowed to spread without sufficient control.