UEAA meets with the Innovation/ Biotechnology bureau of the EU Commission Directorate General for Health and Food Safety (DG Santé)
1.3. 2022The aim of the meeting was to explain and comment on the UEAA Recommendations for an EU regulation frame concerning Genome Editing Research and Development for Crop Plants and Farm Animals and hear the feedback from the relevant EU bureau.
Following the UEAA Recommendations for an EU regulation frame concerning Genome Editing Research and Development for both Crop Plants and Farm Animals published by UEAA on 3 January 2022 and a letter from the President of UEAA to Commissioner Stella Kyriakides (DG Santé) on January 5, 2022, a meeting was organized between the team of the Innovation/Biotechnology bureau of this EU Commission Directorate headed by Mrs S Heinimaa and 5 members of the UEAA Electronic Working Group dedicated to Gene Editing (Michel Thibier, chair, Pere Puigdomènech Rosell, Torbjörn Fagerström, Björn Petersen and Alain Toppan). These 5 members from 4 European countries (France, Germany, Spain, Sweden) were those who contributed to the elaboration of these recommendations further approved by the UEAA governance.
The aim of the meeting was to explain and comments on the Recommendations and hear the feed back from the relevant EU bureau.
Regarding Crop Plants, the UEAA representatives reiterated some facts of great importance relevant to the EU regulation: that the EC Directive was published in 2001 (year of the first plant genome sequencing) therefore much before the new technologies appeared. In addition, the European Court of Justice decision on mutagenesis had led to trouble so there is an urgent need of small changes in the definition of mutagenesis to include targeted changes such as those present in the UEAA recommendations published earlier this year. It was also emphasized the need of plant breeding for sustainability of European agriculture in order to take into account climate changes, consumers needs and requests, biotic threats (insects and pathogens) that the techniques can address now. EU regulations have to change rapidly as some countries have already products in the field and import of harvests and/or germplasm can lead to big trade problems. The attention of the EU commission was drawn to the fact that the present UEAA recommendations for further regulation concerning Crop Plants were very pragmatic and technically simple.
Regarding Farm Animals, the group underlined the urgent need to facilitate Research and Development on Gene Editing in the EU and hence needed an EU regulation to satisfy this need. It was emphasized the fact that there was a first priority in investigating on the use of such Gene Editing techniques for further control and prevention of epizootic and zoonotic animal diseases introducing sustainability and avoiding huge costs every year. Such New Genomic Techniques have also potentially a favorable impact on animal welfare, and being fully aware of the Ethical issues as discussed in many European Research Institutes.
The EU Commission deputy head of unit explained the Commission’s work, including EFSA advices on several techniques (cisgenesis) and mentioned that sustainability is very important and how to contribute to sustainability is not purely science. The last public consultation on this issue of changes in EU regulation received 70 000 advices, 95% of them campaigners (changing the legislation = risks), 500 from stakeholders (pointing the administrative burden) and 1000 from citizens. She added that her office now has to produce an “impact assessment” and this takes time.
Responding to the UEAA group about Animal Gene Editing, questioning if the many papers published on Animal Gene Editing including the risk assessment and Ethical issues had really been taken into consideration, it was responded that animals will only be considered later, the first step being on plants on which EFSA has more experience, as for animals the necessary scientific knowledge is still limited or lacking, especially on safety aspects. The UEAA representatives added that if so, there is a need for further research but EU cannot without excessively strong and limiting constraints which means close to nil, while foreign countries move ahead swiftly.
The EU Commission head of unit claimed that her Directorate is fully aware of what is done in other sectors than plants and she also said that she will come back to UEAA as needed.
At this stage, the EU Commission office told the UEAA group that a new public consultation will be launched in April/May 2022 (on plants and not on animals); they will then complete the “impact assessment” that will be followed by a proposal to the Commission for summer 2023. She invited UEAA to give its input and to be active at the national levels and also to explain what the techniques are all about.
In conclusion, it was a fruitful meeting as recognized by the two parties clarifying the points made by both the EU Commission ad hoc office and UEAA.
Tbilisi, 27 February 2022