Testbiotech EU Newsletter 3/2020 (October 2020)

Most important topics

EFSA defends risk assessment of GE plants / ‘New genetic engineering’ techniques associated with numerous risks / EU Commission authorises genetically engineered soybean MON 87708 x MON 89788 x A5547-127

Current Issues and Activities
  • Lobby activities disguised as science
  • EFSA defends risk assessment of GE plants
  • Genetically engineered microorganisms on the rise
  • Double standards in the safety assessment of genetically engineered soybeans
  • Testbiotech comment on EFSA´s assessment of genetically modified oilseed rape GT73 for renewal of authorisation (Bayer/ Monsanto)
  • Testbiotech comment on EFSA’s assessment of genetically engineered maize MZIR098 (Syngenta)

Scientific news

  • New Genetic Engineering: Oilseed rape produced by Cibus can be tracked and traced
  • New genetic engineering’ techniques associated with numerous risks
  • Indirect’ genetic engineering of honey bees

News from EFSA
  • ‘Annual Report of preparatory work performed during the period 6/12/2019 to 16/07/2020 and 28/11/2018 to 5/12/2019’, and ‘Annual Report of preparatory activities for the evaluation of toxicity studies supporting the GM food/feed safety assessment, performed during the period 28/11/2018 to 5/12/2019’
  • Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2009‐75) for placing on the market of genetically modified oilseed rape Ms8 × Rf3 × GT73 and subcombinations
  • Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788 for food and feed uses
  • Assessment of genetically modified oilseed rape MS11 for food and feed uses, import and processing

New decisions on EU authorisations

  • EU Commission authorises genetically engineered soybean MON 87708 x MON 89788 x A5547-127

Current Issues and Activities

Lobby activities disguised as science
In October, the German National Academy of Sciences, Leopoldina, and the German Research Foundation (DFG) held a virtual conference on New GE. The organisers presented a ‘Statement’ on new genetic engineering techniques (New GE, also called genome editing) and plant breeding, claiming that there are no specific risks associated with the application of genetic engineering in plant breeding, as well as demanding changes to EU GMO regulation. Previously, Testbiotech had sent a letter to Leopoldina president, Prof. Dr. Gerald Haug, raising some serious questions in relation to the statement. For example, several of the experts involved have themselves filed patent applications in the field of genetic engineering. Some of them are also cooperating with companies such as Bayer.
https://www.testbiotech.org/en/news/lobby-activities-disguised-science

EFSA defends risk assessment of GE plants
In July, the European Food Safety Authority (EFSA) responded to the RAGES research project findings (Risk Assessment of Genetically engineered organisms in the EU and Switzerland). The EFSA report was compiled at the request of the EU Commission. As expected, EFSA defended its current practice of risk assessment for genetically engineered plants, despite RAGES having highlighted numerous deficiencies. Testbiotech was involved in conducting the RAGES project and welcomes the EFSA publication. According to Testbiotech, it shows that EFSA and the EU Commission are willing to discuss current risk assessment standards. However, Testbiotech does not consider the EFSA report to have settled the ongoing debate and will provide a detailed response to the various points and issues that EFSA addressed – as well as those that it failed to address.
https://www.testbiotech.org/en/news/efsa-defends-risk-assessment-ge-plants

Genetically engineered microorganisms on the rise - Potential applications to include humans, animals, plants and ecosystems
In July, Testbiotech published a reply to a public consultation held by the European Food Safety Authority (EFSA) on genetically engineered microorganisms. The number of projects aiming to genetically engineer microorganisms has increased strongly in recent years. 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.
https://www.testbiotech.org/en/news/genetically-engineered-microorganism...
Testbiotech input to EFSA consultation: https://www.testbiotech.org/content/testbiotech-input-efsa-consultation-...

Double standards in the safety assessment of genetically engineered soybeans
In May, Testbiotech published a letter to the EU Commission regarding the renewal of two market approvals for genetically engineered (GE) soybeans produced by Bayer. The soybeans (MON89788 and A2704-12) are resistant to applications of the herbicides glyphosate resp. glufosinate. Testbiotech has asked the Commission to withdraw the decision for renewal of market approval, as the risks associated with the GE soybeans were not assessed in accordance with current EU standards. Higher standards in the EU risk assessment of GE plants came into force at the end of 2013. Amongst other things, 90-day feeding studies with whole food and feed have been a requirement since then. Further, field trials with the plants have to be carried out under conditions representative of real agricultural conditions. Neither of the above criteria were fulfilled in the data provided by Bayer.
https://www.testbiotech.org/en/news/double-standards-safety-assessment-g...

Testbiotech comment on EFSA´s assessment of genetically modified oilseed rape GT73 for renewal of authorisation (Bayer/ Monsanto)
Testbiotech published an opinion regarding the renewal of authorisation of herbicide-tolerant (glyphosate) oilseed rape, GT73. The oilseed rape produces two different enzymes that confer herbicide resistance (CP4 EPSPS and GOX proteins).
https://www.testbiotech.org/node/2635
EFSA opinion: http://www.efsa.europa.eu/en/efsajournal/pub/6199

Testbiotech comment on EFSA’s assessment of genetically engineered maize MZIR098 (Syngenta))
Testbiotech published a comment regarding EFSA’s opinion on genetically engineered maize MZIR098 by Syngenta. The insect-resistant and herbicide-tolerant maize produces:
• synthetic Bt toxin eCry3.1Ab (fusion of modified Cry3A (mCry3A) gene and a synthetic Cry1Ab),
• synthetic Bt toxin mCry3A (plant codon optimised Cry3A),
• PAT conferring resistance to the active herbicide ingredient, glufosinate ammonium.
https://www.testbiotech.org/node/2625
EFSA opinion: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6171

Scientific news

New Genetic Engineering: Oilseed rape produced by Cibus can be tracked and traced
A recent publication has shown that a method of identifying oilseed rape plants produced by the US company, Cibus, can be used to distinguish it from other oilseed varieties. Until now, it was often assumed that this was not possible. The Cibus oilseed rape is resistant to the same herbicide as an oilseed rape produced by BASF. While BASF maintains that their plants are derived from conventional ‘random mutagenesis’, Cibus conducted experiments with new GE techniques.
https://www.testbiotech.org/en/news/new-genetic-engineering-confusion-ab...
Publication: https://www.mdpi.com/2304-8158/9/9/1245

‘New genetic engineering’ techniques associated with numerous risks
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.
https://www.testbiotech.org/en/press-release/new-genetic-engineering-tec...
Publication: https://link.springer.com/article/10.1186/s12302-020-00361-2

‘Indirect’ genetic engineering of honey bees
US researchers have filed an application for a patent covering genetically engineered bacteria, including the bees that have the microbes in their gut. According to the patent application, the bacteria can produce molecules which interfere with gene regulation across species boundaries. This means that the honey bees are ‘indirectly’ genetically engineered. According to the US application (US 2019 / 0015528 A1), the patent not only claims the bacteria as an invention, it also includes the honey bees and all other insects in whose gut these genetically engineered bacteria are found. Details of the research can be found of in a publication in the SCIENCE journal.
https://www.testbiotech.org/en/news/indirect-genetic-engineering-honey-bees
Publication: https://doi.org/10.1126/science.aax9039

News from EFSA

Assessment of the 2018 post‐market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU
On 12 October, EFSA published an assessment of the 2018 post‐market environmental monitoring report on MON 810 maize. According to EFSA, “the evidence reported in the 2018 PMEM report does not invalidate previous EFSA evaluations on the safety of maize MON 810.” However, like in previous years, EFSA noted a several shortcomings, especially regarding resistance monitoring.
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6245

‘Annual Report of preparatory work performed during the period 6/12/2019 to 16/07/2020 and 28/11/2018 to 5/12/2019’, and
‘Annual Report of preparatory activities for the evaluation of toxicity studies supporting the GM food/feed safety assessment, performed during the period 28/11/2018 to 5/12/2019’
EFSA published two external scientific reports regarding the analysis of toxicological studies and animal feeding studies included in applications for market authorisation of genetically modified feed/plants.
https://efsa.onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2020.EN-1912
https://efsa.onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2020.EN-1857

Statement complementing the EFSA Scientific Opinion for placing on the market of genetically modified oilseed rape Ms8 × Rf3 × GT73 and subcombinations
On 30 July, EFSA published an additional opinion on oilseed rape Ms8 × Rf3 × GT73 and subcombinations. Previously, EFSA had not been in the position to complete the safety assessment of products rich in protein, such as rapeseed protein isolates or products of this nature in animal feed. Following a mandate from the European Commission, the GMO Panel assessed a 28‐day toxicity study in mice with the glyphosate oxidoreductase (GOXv247) protein. Having assessed the new information, EFSA concluded “that food and feed containing, consisting and produced from genetically modified oilseed rape Ms8 × Rf3 × GT73 and its sub combinations Ms8 × GT73 and Rf3 × GT73, are as safe as its conventional counterpart.”
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6200

Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses
On 18 May, EFSA published an opinion regarding soybean MON 87705 × MON 87708 × MON 89788. This stacked soybean produces dsRNAs downregulating endogenous FAD2 and FATB enzymes for a changed fatty acid profile, and was made resistant to glyphosate and dicamba herbicides. The GMO Panel notes that the applicant did not provide a 90‐day study on MON 87705 soybean in line with the applicable legal requirements. Therefore, the GMO Panel is not in a position to finalise the risk assessment of soybean MON 87705 × MON 87708 × MON 89788.
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6111

Assessment of genetically modified oilseed rape MS11 for food and feed uses, import and processing
On 14 May, EFSA published an opinion regarding male sterile and glufosinate-tolerant oilseed rape MS11.
As the data were incomplete, the compositional analysis, the toxicological, allergenicity and nutritional assessment of oilseed rape MS11 could not be completed by EFSA.
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6112

New decisions on EU authorisations

EU Commission authorises genetically engineered soybean MON 87708 x MON 89788 x A5547-127
On 28 September, the EU Commission authorised soybean MON 87708 x MON 89788 x A5547-127 for food and feed uses. The stacked GE soybean is resistant to three groups of complementary herbicides (glyphosate, glufosinate and dicamba).
https://ec.europa.eu/commission/presscorner/detail/en/mex_20_1761
Testbiotech comment regarding this event:
https://www.testbiotech.org/content/testbiotech-comment-efsa-assessment-...