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EPSO urges the European Commission to take action to prevent the French draft legal proposal from being enacted.
The European Plant Science Organisation (EPSO) is concerned about the draft legal proposal on the genetic modification techniques mentioned in Article L531-2 of the French Environment Code, which would modify the list of techniques of mutagenesis exempt from the scope of the regulations on GMOs. In particular, the draft legal proposal would revoke the exception of in vitro random mutagenesis consisting of subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents. This unilateral restriction of GMO Directive 2001/18/EC disregards scientific literature evidencing the history of safe use of in vitro random mutagenesis, ignores the ruling of the European Court of Justice (ECJ, case C-528/16) reiterating the exemption of all random mutagenesis techniques established before 2001, establishes barriers for research and innovation between member states and will be difficult to enforce by French authorities.
Click here to read: Full EPSO statement 08.07.2020, EPSO submission to the EC 08.07.2020
Contacts:
- Peter Rogowsky, INRAE, FR & EPSO AgT WG chair
- Jens Sundstrom, SLU Uppsala, SE & EPSO
- Karin Metzlaff, EPSO, BE
EPSO agrees with the general statement of EFSA that risk-assessments should be done in a case-by-case manner and that the suggested procedures for risk assessment of SDN-3 that pertain to risk assessments of transgenes do not apply to SDN-1, SDN-2 and oligonucleotide-directed mutagenesis, and should be simplified for these. Furthermore, EPSO suggests clarifications in the definitions of SDN-1 and SDN-2 and the nature of the introduced base changes using these two techniques.
The EFSA public consultation of the applicability of site-directed nucleases type 3 safety assessments on plants developed using site-directed nucleases type 1, type 2, and oligonucleotide-directed mutagenesis.
EFSA has issued in 2012 a scientific opinion on the safety assessments of plants developed using Site-Directed Nucleases type 3, SDN-3 (EFSA, 2012). In these plants, site-directed nucleases have been used to introduce exogenous (recombinant) DNA in a site-specific manner through homologous recombination.
In spring 2020, EFSA issued a draft scientific opinion for public consultation on the applicability of the safety assessments of type 3 site-directed nucleases (SDN-3) on plants developed using SDN-1 SDN-2, or oligonucleotide-directed mutagenesis (EFSA 2020). In plants developed using either of these techniques, no exogenous (recombinant) DNA is inserted into the plants. In SDN-1, predominantly point mutations or short in/dels are introduced through non-homologous end-joining at the target cleavage site. In SDN-2 and oligonucleotide-directed mutagenesis, a short nucleotide sequence is used to guide the inherent DNA-repair mechanism to introduce a few predetermined base changes. Mainly EFSA promotes a case-by-case risk evaluation and outlines possible simplifications concerning specific genome editing methods. If no exogenous (recombinant) DNA is inserted into the plant, the subset of SDN-3 risk assessment protocols that evaluates transgenes are not applicable.
Click here to read: Full EPSO statement 24.6.2020, EPSO submission to EFSA, 28.5.2020
Contacts:
- Jens Sundstrom, SLU Uppsala, SE & EPSO
- Peter Rogowsky, INRAE, FR & EPSO AgT WG chair
- Karin Metzlaff, EPSO, BE
The European Plant Science Organisation (EPSO) welcomes the ongoing European Commission (EC) study on new genomic techniques (NGTs). These are defined as techniques capable of changing the genetic material of an organism, which have emerged or have been developed since 2001. In this statement, EPSO refers specifically to genome editing leading via mutagenesis (point mutations or other modifications existing in nature) in plants and products obtained thereby.
EPSO members remarked that the implementation of GMO legislation with regard to NGTs did not cause any major technical obstacles, but represents a major administrative and financial burden, leads to increasing space constraints in GMO facilities, drastically reduces the number of field experiments, causes problems with the status of incoming germplasm, and has a negative impact on funding and on bringing products to the market.
Despite these constraints, fundamental and applied research on NGTs and NGT products is still blooming in Europe and concerns over 50 plant species. Although the ECJ ruling of 2018 led to widespread demotivation and reduced funding, efforts continue to increase the range of species and of genotypes in which NGTs can be applied, to further enrich the binding and/or cutting features of Cas9-like enzymes, and to generate the knowledge needed to improve traits by NGTs. A research gap exists in the comparison of NGTs to older techniques with a history of safe use.
NGTs and NGT products present numerous benefits and opportunities since they are a tool of choice to address major challenges to agriculture in Europe and worldwide, such as the overuse of pesticides and inputs, climate change, crop monocultures, and the desire for improved food and feed. NGTs can contribute to meeting and managing these challenges by enhancing genetic progress towards more diverse, better adapted, and yet high-yielding plant varieties.
EPSO did not note any specific concerns on NGTs or NGT products but identified obvious challenges. The detection of NGTs in foreign germplasm and products is not feasible, SMEs are not able to play a notable role due to the high cost of licence fees and of regulatory approval, and patents on NGTs and NGT traits raise questions on access to NGT technology and its coexistence with plant variety rights. Safety concerns should not differ from those relevant to plants obtained using methods with a history of safe use, because NGT mutations could also arise in nature or during conventional breeding programs. Off-target events can easily be reduced to a level similar to that of spontaneous mutations occurring during natural plant reproduction in conventional breeding.
The real question on ethical aspects is not whether NGTs or NGT products as such are acceptable, but whether the use we make of them supports commonly accepted values and avoids harm to humans and the environment. It would be ethically problematic to reject NGTs having beneficial traits, provided they are not considered to pose a higher risk to humans or the environment than similar varieties developed by conventional methods.
With regard to consumers’ right for information and freedom of choice, EPSO is opposed to obligatory labelling because it implies that NGT products as such are harmful or problematic, could not be enforced, and would lead to both labelling and non-labelling of identical products. Voluntary labelling has the advantage of giving voice to different types of values, maintaining information levels equal to all actors, and taking into account various lifestyle choices.
NGTs and NGT-products have a role to play in the European Farm-to-Fork strategy by ensuring sustainable food production and the shift to healthy, sustainable diets, for example through disease resistant crops, reducing pesticide use, and allergen-free food that promotes human health. They can also contribute to implement the European Biodiversity strategy by improving the performance and nutritional content of underutilised fruit, vegetable and cereal crops and thereby substantially increase diversity of cultivated crops.
Click here to read: Full EPSO statement 27.5.2020, EPSO submission to the EC 13.5.2020, EPSO Reference list submitted to the EC 13.5.2020
Contacts:
- Peter Rogowsky, INRAE, FR & EPSO AgT WG chair
- Frank Hartung & Ralf Wilhelm, Julius Kühn-Institute (JKI), DE & EPSO AgT WG chairs
- Karin Metzlaff, EPSO, BE
Genome editing: Improving legislation and starting flagships to better address climate, environmental, food and health challenges
2nd Informal meeting in Brussels 24.1.2020
Brussels, 24.4.2020
On 24 January 2020 EPSO invited tandems of member-scientists and policy makers from a dozen countries across Europe to a second open-minded, informal meeting to assess the situation for research and development on New Plant Breeding Technologies (NPBTs) after the ruling of the ECJ in July 2018.
The difficulties in the implementation of the ruling, the possible need for changes to present legislation and the status of activities in different member states and associated countries were discussed. Flagship projects with potential field releases were a further point of consideration. There shall be a follow up meeting in autumn 2020.
As explained in our statement of 19.2.2019, EPSO offers to collaborate with policy makers to develop an appropriate future-ready regulation to enable the European public sector, small- and medium-sized companies and farmers to contribute more comprehensively to food and nutritional security and to use all available tools to reduce the environmental impact of agriculture. Notwithstanding the technical option retained, EPSO supports a science-based revision of the present European legislation establishing a more proportionate product-based risk assessment. EPSO is also willing to contribute to the societal debate on genome editing and to communicate in a fact-based and yet accessible manner about innovative plant science and its societal role.
Ralf Wilhelm, Ernst van den Ende and Karin Metzlaff
Contacts:
- Ralf Wilhelm, JKI / DE and co-chair EPSO Agricultural Technologies WG
- Ernst van den Ende, WUR / NL and EPSO Board member
- Alan Schulman, LUKE / FI and EPSO President
- Karin Metzlaff, EPSO Executive Director
Informal meeting in Brussels 19.9.2019
Brussels, 4.11.2019
On 19 September 2019 EPSO invited tandems of member-scientists and policy makers from a dozen countries across Europe to an open-minded, informal meeting to assess the situation for research and development on New Plant Breeding Technologies (NPBTs) after the ruling of the ECJ in July 2018.
The difficulties in the implementation of the ruling, the possible need for changes to present legislation and the status of activities in different member states and associated countries were discussed. Flagship projects with potential field releases were a further point of consideration. There shall be a follow up meeting in early 2020.
As explained in our statement of 19.2.2019, EPSO offers to collaborate with policy makers to develop an appropriate future-ready regulation to enable the European public sector, small- and medium-sized companies and farmers to contribute more comprehensively to food and nutritional security and to use all available tools to reduce the environmental impact of agriculture. Notwithstanding the technical option retained, EPSO supports a science-based revision of the present European legislation establishing a more proportionate product-based risk assessment. EPSO is also willing to contribute to the societal debate on genome editing and to communicate in a fact-based and yet accessible manner about innovative plant science and its societal role.
Ralf Wilhelm, Ernst van den Ende and Karin Metzlaff
- Ralf Wilhelm, JKI / DE and co-chair EPSO Agricultural Technologies WG
- Ernst van den Ende, WUR / NL and EPSO Board member
- Karin Metzlaff, EPSO Executive Director
Read the Meeting report here
Links:
- https://epsoweb.org/working-groups/agricultural-technologies/
- EPSO statement (endorsed by all EPSO Representatives for 197 institutes / universities), 19.2.2019
EU health Commissioner Andriukaitis stated in his interview with EURACTIV on 27.3.2019 (link) “From my point of view, we need a new legal regulatory framework for these new techniques,”, adding that it should be dealt with by the new European Commission after the EU elections in May. He added “We are currently analysing the ruling and discussing with member states its implementation”. Further on in the interview he insisted that Europe should listen to science, otherwise “it has no chance to have sustainable agriculture and preserve biodiversity”.
EPSO welcomes this statement and call for action by Commissioner Andriukaitis and repeats its offer to collaborate with policy makers to develop an appropriate future-ready regulation to enable the European public sector, small- and medium-sized companies and farmers to contribute more comprehensively to food and nutritional security and to use all available tools to reduce the environmental impact of agriculture. Notwithstanding the technical option retained, EPSO supports a science-based revision of the present European legislation establishing a more proportionate product-based risk assessment. EPSO is also willing to contribute to the societal debate on genome editing and to communicate in a fact-based and yet accessible manner about innovative plant science and its societal role.
Background: EPSO publishes its statement to the ruling of the European Court of Justice (ECJ) on organisms obtained by mutagenesis (case C-528/16)
This refers to the Court of Justice of the EU: Judgment in Case C-528/16, 25.7.2018.