Max Planck Society withdraws all claims covering vertebrates

19 February 2021 / Testbiotech has won an important opposition filed at the European Patent Office (EPO). A patent held by the Max Planck Society will now be changed to delete all claims covering genetically engineered vertebrates. In its original form the patent covered many different species from mice to great apes. The animals were to be genetically engineered to develop symptoms of Parkinson disease and for use in experiments. The new EPO decision was based on ethical considerations; the expected suffering of the animals would have been disproportionate to any substantial medical benefit as requested in European law.

European Food Safety Authority presents new report

18 February 2021 / The European Food Safety Authority (EFSA) has published another report on the risk assessment of plants developed with new genetic engineering (New GE). The report includes plants generated using gene scissor CRISPR/Cas applications where no new additional genes are inserted (so-called SDN-1 applications). The EFSA report shows that detailed risk assessment must be carried out even if no additional genes are inserted. The report is the outcome of a consultation which included Testbiotech.

The example chosen by EFSA is wheat, derived from application of CRISPR/Cas, with a strongly reduced gluten content. This protein is thought to trigger inflammatory responses. Using CRISPR/Cas meant that several dozen genes and gene copies in the wheat genome were changed at the same time. EFSA rightly concludes that these complex patterns of genetic change go beyond what has been achieved in genetic engineering and conventional breeding thus far. EFSA explained that if an application for market approval was filed, then risk assessment should take issues such as molecular changes, gene expression and the potential impact on health and the environment into account.

European “Stop Gene Drives” campaign demands global moratorium

Brussels, 27.01.2021

Should humanity release genetically engineered gene drive organisms into nature? The response of a majority of citizens in eight European countries is: “No, the risks are too high”. This first opinion poll on the subject shows high levels of opposition to (46% - 70%) and very low levels of support for (7% - 16%) the use of Gene Drive technology in the environment. The survey of nearly 9,000 people is representative of 280 million EU citizens from eight EU countries. It was commissioned by nine NGOs demanding an informed and inclusive public debate and a global moratorium on the environmental release of this new type of genetically modified organisms. The survey also reveals that a large proportion of respondents were still undecided (14% - 27%) or did not know how to answer (1% - 24%).

CRISPR/Cas gene scissor applications cause changes in gene regulation

18 December 2020 / A new scientific publication shows that CRISPR/Cas gene scissor applications in animals unintentionally leave traces. The findings are not related to unintended changes in the DNA, which have often been described, but to gene regulation, i.e. epigenetics. The effects are heritable and may, for example, result in disruption of embryonic development.

The new scientific publication describes CRISPR/Cas experiments with mice in which their DNA is cut and additional genetic information inserted. Besides intended changes in DNA in the target region, the findings also showed unintended changes in so-called epigenetic markers that control gene regulation. The effects were heritable and could still be identified after ten generations. According to the authors, the effects can also be used to identify CRISPR/Cas gene scissor applications.

EFSA has for decades ignored crucial data from Monsanto

Friday, 11 December 2020

Data from Monsanto revealed that Bt proteins expressed in genetically engineered (GE) plants are significantly more toxic than natural Bt toxins. It is more than 30 years ago since, in 1990, Monsanto data first showed that if mixed with plant material from, e.g. soybeans, cotton and maize, toxicity could be up to 20 times higher. This is due to enzymes naturally present in the tissues of many crop plants. These findings were never taken into account by the European Food Safety Authority (EFSA). It seems as if EFSA simply overlooked the relevant publications. EFSA routinely accepts tests with isolated Bt proteins produced by bacteria to assess the risks of GE plants.

Testbiotech became aware of this 30-year old Monsanto publication whilst assessing new applications for import approval of GE plants. Testbiotech has also become aware of several more recent publications confirming the original Monsanto findings.

Worldwide poisonings up from 25 million in 1990 to 385 million today

In a comprehensive new study, scientists report that pesticide poisonings on farms around the world have risen dramatically since the last global assessment 30 years ago. Based on an evaluation of available poisoning data from countries all over the world, the researchers conclude that there are about 385 million cases of acute poisonings each year, up from an estimated 25 million cases in 1990.

This means that about 44% of the global population working on farms — 860 million farmers and agricultural workers – are poisoned every year.

The systematic review of unintentional acute pesticide poisonings was published today in the peer-reviewed journal BMC Public Health. The article, entitled “The global distribution of acute unintentional pesticide poisoning: Estimations based on a systematic review,” is the first such global estimate since 1990.

Opinion of the EU authority considered insufficient and misleading

25 November 2020 / Testbiotech is extremely critical of a recent European Food Safety Agency (EFSA) opinion on the risks associated with plants derived from new genetic engineering (New GE). It considers the EFSA report on CRISPR & Co is both inadequate and misleading on the protection of health and the environment.

In its opinion published yesterday, EFSA claims that applications of gene scissors, such as CRISPR/Cas on plants, do not pose any specific risks as long as no additional genes are inserted. At the same time, EFSA agrees with Testbiotech that New GE opens up the way to new genetic combinations since it makes the whole genome accessible for changes caused, for example, by targeting several genes at once.

The European Food Safety Agency (EFSA), on 12.11.2020 published an assessment on whether the currently existing European guidelines for the risk assessment of genetically modified insects are sufficient for the risk assessment of genetically modified Gene Drive insects.

Mareike Imken, Gene Drive policy advisor at Save Our Seeds for Gene Drive technology, comments on this:

EFSAs assessment, that existing guidelines for genetically engineered insects are insufficient in order to conduct environmental risk assessment for Gene Drive Organisms,

confirms our analysis. Due to their novel characteristics it will be extremely challenging – if not impossible – to uimodel, predict and monitor the behaviour of these genetically engineered organisms.

New report - frequently asked questions about CRISPR & Co

22 October 2020 / Testbiotech is publishing a new report today on New Genetic Engineering (New GE) that shows why these techniques need to be strictly regulated. New GE - or ‘genome editing’ - opens up new possibilities which go way beyond conventional breeding and previous methods of genetic engineering. One of the most important tools in this scenario are CRISPR/Cas gene scissors (nuclease). In contrast to chemical or physical mutagens used in conventional breeding, tools such as CRISPR/Cas can directly interact with biological mechanisms in the cells.

Recent research clearly shows that there are major differences in New GE compared to conventional breeding: over the course of evolution, mechanisms have emerged which can protect specific genomic regions against too frequent mutations. These mechanisms can be described as the ‘flexible safety barriers’ of evolution, and are also effective in conventional breeding. They appear to be relevant to regions in the genome that are of some importance to the survival of a species. New GE is designed to circumvent these mechanisms.

Testbiotech warns against hype around genetic engineering technology

7 October 2020 / The inventors of the CRISPR/Cas “gene-scissor” technology have been awarded the Nobel Prize. Christoph Then from Testbiotech comments as follows: “This is a Nobel Prize that could potentially open up ‘Pandora’s Box’. The future of our earth now depends substantially on whether we will be able to set clear and strict limits to this new genetic engineering technology. We must protect human, plant and animal genomes from becoming an object of technological hubris and financial gain.”