Testbiotech EU Newsletter 2/2020 (May 2020)

Will Bayer GE soybeans be allowed for use in food production without safety being demonstrated?
In May, the EU Parliament voted with a huge majority against the import of genetically engineered (GE) soybeans (MON 87708 x MON 89788 x A5547-127) resistant to three herbicides produced by Bayer. The European Food Safety Authority (EFSA) considered the soybeans which inherit several transgenes, to be safe for human consumption. However, according to the EU Parliament, the risk assessment was not sufficient. One reason: the soybeans have not been tested for combinatorial effects arising from the genetic interventions and the residues from spraying with herbicides glyphosate, dicamba and glufosinate.
https://www.testbiotech.org/en/news/bayer-ge-soybeans-allowed-without-sa...

EFSA holding public consultation on new methods of genetic engineering
The European Food Safety Authority (EFSA) is holding a public consultation on plants developed with new methods of genetic engineering (genome editing). The EFSA draft document looks at changes made to the genome using tools such as CRISPR/Cas, but without the insertion of additional gene sequences. Testbiotech has concluded that the published draft suffers extensively from not taking numerous relevant publications and important scientific findings into account. Comments can be submitted until 27 May.
https://www.testbiotech.org/en/news/efsa-holding-public-consultation-new...
Link to the consultation: http://www.efsa.europa.eu/en/consultations/call/public-consultation-appl...

Comment on EFSA gene drive consultation and new scientific paper - Testbiotech demands that ‘cut-off’ criteria are applied
The European Food Safety Authority (EFSA) carried out a public consultation on guidance for the risk assessment of so-called gene drives at the request of the EU Commission. At the same time, a new Testbiotech scientific paper was accepted after peer review. The paper shows that the EFSA concept is insufficient. To control the risks of gene drives, ‘cut-off criteria’ need to be defined to prevent the uncontrolled spread of genetically engineered organisms.
Link: https://www.testbiotech.org/en/news/EFSA-discusses-risk-assessment-of-ge...
The EFSA consultation: http://www.efsa.europa.eu/en/consultations/call/public-consultation-gmo-...

Testbiotech report: strict regulation of new genomic techniques is scientifically necessary
In a new report published in March, Testbiotech provides an overview of the latest research developments in environmental risk assessment and new methods of genetic engineering. The authors come to the conclusion that there are imperative scientific reasons for all organisms derived from these new techniques to undergo mandatory risk assessment before they can be released or marketed. Therefore, regulation requirements foreseen by current GMO law in the EU must be mandatory whether or not additional DNA sequences are inserted. In addition, a broad range of ethical and social issues must be taken into account by the regulatory decision-makers.
https://www.testbiotech.org/en/news/new-report-strict-regulation-new-gen...
The report: https://www.testbiotech.org/node/2569

Will there be GMO fast track approvals in the EU? Testbiotech warns about planned trade deal with the US
Testbiotech has warned in a letter to the EU Commission against a planned trade agreement between the EU and the Trump administration. The deal might allow fast track approvals for genetically engineered plants. Such plans were reported by the media in Brussels. They would be contrary to the views of many experts in EU member states and independent scientists, who have repeatedly drawn attention to substantial insufficiencies and gaps in current EU risk assessment. Current standards in risk assessment should be substantially tightened rather than weakened as demanded by the US government and industry.
https://www.testbiotech.org/en/news/will-there-be-gmo-fast-track-approva...

Follow-up: Trade deal with US: EU Commission is keeping the doors wide open
In an answer to Testbiotech, the EU Commission rejected the concerns regarding a new trade deal with the US. According to the letter from the EU Commission, there are no plans to change the legal standards. However, “on the other hand, the EU and the US are engaged in regular dialogues on biotechnology policies in both parties, with a view to exchange information and foster cooperation in innovative biotechnology fields.”
https://www.testbiotech.org/en/news/trade-deal-us-eu-commission-keeping-...

Import approval for genetically engineered maize: Did Monsanto benefit from unlawful exploitation of transitional provisions?
Testbiotech is concerned that Monsanto (Bayer) unlawfully obtained an import authorisation for genetically engineered maize without a proper risk assessment as required by EU regulations. The reason: officially, Monsanto filed its application for market approval just before a more rigorous EU regulatory framework for risk assessment came into force. However, there are doubts that the application was actually filed in time.
https://www.testbiotech.org/en/news/dubious-import-approval-genetically-...

Legal proceedings started against patents on human embryonic stem cells and interventions in the human germ line
Testbiotech started legal proceedings in two cases against patents. The cases were initiated to clarify fundamental ethical questions in patent law, especially in regard to the protection of human dignity. A case was filed at the German Federal patent court (Bundespatentgericht) in a bid to nullify the German patent (DE102004062184), which claims uses of human embryos to obtain stem cells. In addition, Testbiotech has filed an opposition to a European patent on uses of the so-called CRISPR/Cas gene scissors; the well-known scientists Jennifer Doudna and Emmanuelle Charpentier are named as the inventors in this patent (EP3401400). The human germ line and the commercial use of human embryos are not definitively excluded in this patent as required in law. In addition, the patent claims the application of CRISPR/Cas on plants and animals.
https://www.testbiotech.org/en/press-release/legal-proceedings-patents-h...

Testbiotech comment regarding EFSA opinion on maize MON88017 for renewal
Testbiotech published an analysis of EFSA’s opinion regarding maize MON88017. This maize produces Cry3Bb1 protein toxic to the larvae of Coleoptera (beetles) that feed below the ground and a CP4 EPSPS protein for tolerance to glyphosate-containing herbicides.
https://www.testbiotech.org/content/testbiotech-comment-efsa-maize-mon88...
EFSA opinion: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6008

Testbiotech comment regarding EFSA opinion on soybean SYHT0H2
Testbiotech published an analysis of EFSA’s opinion on soybean SYTH0H2. The soybean contains genes conferring resistance to two groups of herbicides, glufosinate and mesotrione, as well as other HPPD inhibitors (such as isoxaflutole).
https://www.testbiotech.org/en/node/2562
EFSA opinion: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.5946