NGTs, new GMOs. Scientists and Anses expose the risks of deregulation

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The proposal for the ‘deregulation’ of new GMOs (NGTs) – presented by the European Commission on 23 July 2023 (1) – did not gain the consensus of the Member States under the Spanish Presidency of the Council, as we have seen. (2) Scientists meanwhile raise their voices to expose the serious risks that may arise for the environment and biodiversity, human and animal health.

Hundreds of university professors and researchers in the areas of biotechnology, agronomy, biology, genetics, veterinary medicine and other subjects had already published – on 13 September and 19 November 2023 – two joint declarations which conclude with the request for rejection or radical modification of the proposal of the European Commission (3,4).

On 21 December 2023, Anses, the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, in turn published a scientific opinion on the deregulation proposal. Focusing on the substantial unfoundedness of the assertion of equivalence of ‘category 1 NGTs’ with plants derived from conventional techniques. (5)

1) NGTs, new GMOs. The European Commission’s deregulation proposal

The European Commission – in the proposal for the deregulation of new GMOs or NGTs (New Genomic Techniques), already announced by the MEP Paolo De Castro at the beginning of the legislature which is now coming to an end (6) – hypothesizes equalizing ex law plants to which a genome sequence has been modified, or genetic material inserted from plants of the same species, to those obtained through traditional selection methods. On the false assumption of their ‘indistinguishability‘.

Deregulation it should be total for new GMOs (NGTs) obtained with less than 20 genetic insertions which, in Brussels’ ambitions, would be exempt from:

– any preliminary risk assessment. A notification of the producers to the national authorities would be sufficient, in view of their marketing and deliberate release into the environment;

– notification to Brussels of a unique indicator of the new GMO, or other useful tools for tracing its traits and propagation in the environment;

–  traceability and information requirements for citizens and consumers. With the expectation of labeling only the seeds as ‘new genomic techniques category 1’.

The new GMOs made with more than 20 genetic modifications would in turn be subject to partial deregulation, through a ‘light risk assessment’. With all due respect to the ruling of 25 July 2018 of the Court of Justice of the European Union (CGEU), which equated the new GMOs (NGTs) to ‘traditional’ ones in all respects. (7) The ENVI Commission of the European Parliament then took matters further, proposing to allow their use also in organic farming. (8)

2) Statements from independent scientists

Two groups of independent scientists with specific expertise in biotechnology – but without personal interests – and matters related to the possible impacts of new GMOs on people, animals and ecosystems have published two declarations denouncing the risks linked to the deregulation proposed by the European Commission. To support an independent risk assessment, as required by Directive 2001/18/EC which is still in force.

Member States and the Commission should ensure that systematic and independent research on the potential risks involved in the deliberate release or the placing on the market of GMOs is conducted. The necessary resources should be secured for such research by Member States and the Community in accordance with their budgetary procedures and independent researchers should be given access to all relevant material, while respecting intellectual property rights‘. (9)

3) The risks deliberately ignored in Brussels

Independent scientists highlight that the Commission’s legislative proposalcannot ensure health and environmental safety if NGT plants or products derived from them are released into the environment or placed on the EU market‘. Indeed:

– the mutations obtained with the CRISPR/Cas tool are not comparable to those that occur naturally. The CRISPR/Cas ‘genetic scissors’ can in fact alter the genetic sequences (genotype), and thus the genetic function and characteristics of the plant (phenotype), in a way that is unlikely to occur in conventional selection;

– the threshold of 20 genetic mutations, used to distinguish NGTs of category 1 (totally unregulated) and 2 (subject to ‘rapid’ or summary risk assessment, in any case different from that adopted so far for the approval of ‘traditional’ GMOs ) is completely devoid of scientific basis;

– it is scientifically incorrect to believe that the risks to health and the environment deriving from NGTs plants are ‘generally lower’ than ‘classic’ transgenic plants.

4) Risk assessment

The risks that plant NGTs can cause to health, the environment and biodiversity must be assessed on a case-by-case basis. The precautionary principle must be applied to concrete situations, as in fact already provided for in Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment.

Risk assessment relating to old and new GMO plants – explain the two groups of independent scientists – therefore requires the detailed examination of the genetic changes or biological traits (voluntary or involuntary) present in the plant and which would hardly have been obtained with traditional genetic selection techniques .

5) Impact on the environment, food safety

The deliberate entry of NGTs in the open field, the scientists continue, must be done in a controlled and limited way as the damage to the environment and biodiversity that they can cause cannot be predicted. With particular attention to cumulative effects, which can lead to interference or interruptions in the evolutionary processes of the ecosystem.

Food safety, in turn, cannot be neglected. Genome editing techniques can in fact cause unwanted changes in plant DNA. And in the absence of an appropriate risk assessment, the researchers point out, it cannot be ruled out that genomic alterations could have an impact on human or animal health.

6) Anses, scientific opinion on the risks of deregulation of NGTs

Anses – the independent French national agency, with responsibility for the assessment of health and food safety risks – in turn published a scientific opinion on 21 December 2023, which highlights the risks linked to the deregulation proposed by the European Commission. (4) Noting, in particular, the following critical issues:

– new genomic techniquescan lead to changes in the biological functions of plants that have not been taken into account in the Commission proposal‘ – as regards ‘category 1 NGTs’ – and ‘it cannot be ruled out that they may lead to health and environmental risks‘;

– the ‘equivalence criterion’ between plants derived from conventional techniques and ‘category 1 NGTs’ is uncertain and essentially devoid of scientific justification. The threshold for genetic modifications should also be established according to the size of the genome of each plant;

– the margins of interpretative discretion must be reduced to a minimum. Introduce the definitions of ‘conventional plant’, ‘targeted site’ (of the intervention on the genome, which should distinguish NGTs), ‘genetic material’ or ‘gene pool of breeders’,

– it is also necessary to clarify the scope of application of the techniques in question. Thus, for example, clearly formulating the exclusion from category 1 of plants derived from non-targeted intragenesis or cisgenesis.

7) Provisional conclusions

The deregulation project under consideration could have a deadly impact not only on the environment and health but even more so on biodiversity, with possible damage to the health of the soil and productivity in agriculture. Risks already highlighted not only by environmentalists and civil society – who have never accepted GMOs – but also by the same researchers who participated in the development of genome editing techniques (10,11).

The ‘indistinguishability’ between deregulated (but patentable) GMOs and traditional plants could force European farmers to increasingly depend on the four global monopolists of pesticides and seeds, also through the imposition of royalties following accidental contamination. (12) Exacerbating the imbalances of a supply chain where the growing costs of agricultural production are not compensated by the selling prices of foodstuffs.

A broader reflection compared to the stadium contrasts between pros and cons of NGTs it appears necessary. The appeal of independent scientists and civil society must be understood in this sense, the possible advantages of innovation are not denied a priori but further and in-depth impact assessments are necessary. Without improvising political negotiations at the end of the legislature based solely on the urgencies of the dominant lobbies.

Dario Dongo

Footnotes

(1) Dario Dongo. New GMOs, NGTs. The European Commission’s deregulation proposal. GIFT (Great Italian Food Trade).

(2) Marta Strinati, Dario Dongo. New GMOs, member states hesitate on deregulation. GIFT (Great Italian Food Trade).

(3) Antoniou, M.N., Robinson, C., Castro, I. et al. (2023). Agricultural GMOs and their associated pesticides: misinformation, science, and evidence. Environ Sci Eur 35, 76. 13.9.23 https://doi.org/10.1186/s12302-023-00787-4

(4) Open Letter: Serious concerns about the EU Commission proposal on New Genomic Techniques. New GMO. 19.11.23 http://tinyurl.com/39p6xsmm

(5) Anses. AVIS de l’Anses relatif à l’analyse scientifique de l’annexe I de la proposition de règlement de la Commission européenne du 5 juillet 2023 relatable aux nouvelles génomiques (NTG) – Examen des critères d’équivalence proposed to define the NTG plants of category 1 https://www.anses.fr/fr/content/avis-2023-auto-0189

(6) Dario Dongo. GMO, the new empire that is advancing. GIFT (Great Italian Food Trade).

(7) Dario Dongo, Giulia Torre. New GMOs, Alt from the EU Court. GIFT (Great Italian Food Trade).

(8) Dario Dongo. New GMOs in organic farming? The proposal of the European Parliament. GIFT (Great Italian Food Trade).

(9) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Recital 21

(10) Dario Dongo, Riccardo Clerici, Silvia Comunian. New GMOs, it is essential to strengthen the risk analysis. Scientific review. GIFT (Great Italian Food Trade).

(11) NBT, the dark side of the new editing techniques. Scientific review. GIFT (Great Italian Food Trade).

(12) New Genomic Techniques + Patents = Ticking time bomb. IFOAM http://tinyurl.com/yr6jj2rh

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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.