French Food Safety Agency Says Proposal to Deregulate New GMOs Has No Scientific Basis

TWN Info Service on Biosafety
30 January 2024
Third World Network
www.twn.my

Dear Friends and Colleagues

French Food Safety Agency Says Proposal to Deregulate New GMOs Has No Scientific Basis

The French government’s food safety agency ANSES has demolished the European Commission’s proposal for a definition of a class of new GM plants (so-called Category I NGT plants) that would be exempted from risk assessment, traceability and labelling because of their supposed “equivalence… to conventional plants”.

In a report issued in December 2023, ANSES says that there is no scientific basis for such an assumption of equivalence of type of trait or level of risk between two categories of plants on the basis of equivalent content of genetic variations or modifications defined solely by their type, size and number (Item 1). A mutation may be “small” but have large consequences, such as making the plant toxic or allergenic. It is thus vital that risk assessment, traceability and labelling be retained for all GMOs.

Regretting the lack of clarity in many terms, and even the absence of definitions, ANSES noted “certain scientific and health limitations in the construction of the criteria” proposed to deregulate GMOs. The French experts believe that a comparison of possible consequences on a biological function should be made, i.e. that a risk assessment should not be put aside. (Item 2)

This year will see the continuation of the discussions begun in 2023 within the Council of Ministers and the European Parliament on the European Commission’s proposal. A new legislation to deregulate new GMOs may or may not be adopted. If adopted, it will not be possible to claim that such a decision is based on “good science”, concludes ANSES.

With best wishes,
Third World Network

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Item 1

FRENCH FOOD SAFETY AGENCY ANSES DEMOLISHES COMMISSION’S ASSUMPTIONS OF “EQUIVALENCE” FOR GM PLANTS

By Claire Robinson
GM Watch
https://gmwatch.org/en/106-news/latest-news/20353-french-food-safety-agency-anses-demolishes-commission-s-assumptions-of-equivalence-for-gm-plants
10 January 2024

ANSES says there is “no scientific basis” for Commission’s proposal to remove regulatory safeguards from new GMOs.

The French government’s food safety agency ANSES has demolished the European Commission’s proposal for a definition of a class of new GM plants (so-called Category I NGT plants) that would be exempted from risk assessment, traceability and labelling because of their supposed “equivalence… to conventional plants”.

The Commission has specifically proposed as the criterion for this equivalence a threshold of no more than 20 genetic modifications per plant, at the target site and at sites with similar sequences, and a size of 20 nucleotides for insertions and substitutions.

But ANSES says there is no scientific basis for such an assumption of equivalence. It states:

“The Commission’s technical document states that ‘similar genetic modifications obtained by different techniques are not assumed to present different risks’, and ‘if certain types and numbers of mutations can be introduced by conventional breeding techniques as well as by NTGs, then the type of traits associated with these mutations will not differ between these techniques’. It concludes that it is sufficient to consider only the type and number of mutations to assess equivalence between these plants, and that it is not necessary to consider the associated effects.

“The Biotechnology WG [ANSES’ working group of experts on biotechnology] considers that there is no scientific basis for equivalence of type of trait or level of risk between two categories of plants on the basis of equivalent content of genetic variations or modifications defined solely by their type, size and number.

“The WG points out that genetic variability or genetic variations observed in nature are the product of thousands of years of evolution, drift or natural selection. Genetic variations or modifications observed in varieties produced by conventional breeding techniques have undergone selection by breeders.

“In both cases, genetic variations or modifications associated with deleterious effects are eliminated, whether in terms of the plant’s fitness or its selective value in nature, or in terms of the agronomic and qualitative characteristics sought by man in conventional breeding programmes. The elimination or selection of these variations and modifications is not based on their type, size or number, but on their potential impact on a biological function.

“The Biotechnology WG emphasises that the functional or biological consequences of a given genetic variation or modification are not determined by its type or size.

“Nevertheless, when analysing the proposed equivalence approach, which focuses on the types, sizes and number of genetic modifications, the Biotechnology WG considers that the thresholds of 20 genetic modifications per plant, at the target site and at sites with similar sequences, and a size of 20 nucleotides for insertions and substitutions, are not justified. Nor is the acceptance of any deletion or inversion without conditions, or, to a lesser extent, of targeted cisgenesis without target orthology conditions. Nor is the lack of consideration for potential modifications outside the targeted sites and similar sequences (with the exception of transgenic elements, due to the definition of the NGT plant) justified.”

ANSES adds, “The possibility or probability that a given modification or combination of modifications could be obtained by conventional techniques should be considered.”

This last point is important. While it is theoretically possible for a chimpanzee with a word processor to write this article, the likelihood that this will happen in any realistic timeframe is practically zero. Nowhere has the Commission or its supporters defined the probability of the claim that any given GMO could occur through traditional processes or that such a GMO would have equivalent biological effects to those of a conventional plant.

We agree with ANSES’s analysis. Basing assumptions of equivalence between GMOs and conventional organisms on arguments related to type, number, and size of mutations is not scientifically based and puts public health and the environment at risk. A mutation may be “small” but have large consequences, such as making the plant toxic or allergenic. It is vital that risk assessment, traceability and labelling are retained for ALL GMOs.

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Item 2

FRENCH ANSES EXPERTS : GMO DEREGULATION HAS « NO SCIENTIFIC BASIS »

Eric Meunier
Inf’OGM
https://www.infogm.org/7964-french-anses-experts-gmo-deregulation-has-no-scientific-basis?lang=fr
22 January 2024

French experts from the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (Anses) are highly critical of the scientific criteria proposed by the European Commission to deregulate GMOs. In their report, published on December 21, 2023, they state that the basic assumption linking equivalence and absence of risk has « no scientific basis ». The same applies to the criteria proposed by the Commission to declare a GMO/NTG plant equivalent to a conventional plant.

Since September 2023, Member States and MEPs have been discussing the GMO deregulation proposal presented by the European Commission (EC) on July 5, point by point. In these discussions, the scientific basis of the proposed rules should be one of the points of attention. On this subject, the report by French experts of the Anses, published in December 2023, is likely to fuel discussions in 2024 [1]. Regretting the lack of clarity in many terms, and even the absence of definitions (see box), the experts noted « certain scientific and health limitations in the construction of the criteria » proposed to deregulate GMOs.

Equivalence between plants, equivalence of risks?

For the European Commission, if two plants are « equivalent », then so are the risks they present, and their regulatory framework should therefore be the same. It states that new techniques of genetic modification (called new genomic techniques, NTG) « can result in organisms with modifications equivalent to what can be obtained by conventional breeding methods » [2]. The European Commission therefore asserts that NTG plants that could also occur naturally or be produced by conventional breeding techniques « and their progeny […] should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable, thereby derogating in full from the Union GMO legislation » [3].

This assumption, based on the conditional « could », is the keystone of the deregulation proposed by the European Commission. But for the experts at Anses, there is « no scientific justification [for declaring that] categories of plants that would be equivalent in type, size and number of genetic variations or modifications would be equivalent in type of traits and level of risk ». The European Commission’s main shortcoming is that it ignores « thousands of years of evolution, drift or natural selection » by asserting that genetically modified plants in the state of cells isolated on a laboratory bench are equivalent to plants selected naturally or by conventional methods on the sole basis of the number, size or type of genetic modifications carried out. The French experts believe that a comparison of « possible consequences on a biological function » should be made, i.e. that a risk assessment should not be put aside.

Following this logic, they add that ignoring, as proposed by the EC, « unintended genetic modifications potentially located outside the targeted sites and similar sequences (apart from transgenic elements) is not justified ». An ignorance that could pose a problem, as such off-target modifications can be « insertions/deletions, reading frame shifts or any type of structural variations » with associated consequences. Should the proposed regulation be read in this way, it would be no more justified to count such effects among the claimed genetic modifications « without considering their possible negative effects ».

Scientifically unjustified criteria

While they would prefer to see a study of the new biological functions obtained, the French experts see little scientific logic in the criteria proposed by the European Commission to declare a plant and its progeny equivalent to a conventional plant, and therefore « NGT category 1 » [4]. Such plants would be exempt from risk assessment, labelling, traceability and post-marketing monitoring [5].

Thus, the type 1 criterion proposed by the Commission, i.e. a « substitution or insertion of up to 20 nucleotides » is not the subject of any « scientific justification for accepting (in the sense of equivalence) substitutions or insertions on the basis of their size. Furthermore, the maximum threshold of 20 nucleotides for an insertion or substitution has not been shown to be particularly relevant for the definition of equivalence to conventional plants ».

Type 2 criterion, concerning « deletions of any number of nucleotides », does not appear to be more justififed, since « regardless of their size, the functional consequences of these deletions should be characterized ».

The very complex type 3 criterion is also the subject of comment. It covers cisgenesis, with « targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool » and « targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool ». In the case of cisgene insertions (cisgenesis), French experts consider that the NTG plant obtained can only be deemed equivalent to a conventional plant if the inserted sequence is positioned in the recipient plant at the same site as the one from which it originated in the donor plant (known as an orthologous site).

For criterion type 4, i.e. « targeted inversion of a sequence of any number of nucleotides », the experts simply state that « this inversion criterion without size conditions does not seem justified ».

Finally, criterion type 5, which looks at « any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (…) in a species from the breeders’ gene pool », seems to carry a lack of clarity and opens the door to possible deregulation of intragenic plants [6]. However, they believe that « a criterion leading to intragenic plants being exempted from the requirements of GMO legislation would not be justifiable ».

Experts not consulted by politicians

Apart from their opinion, it is striking to note that the French experts took the matter into their own hands. In other words, the French government, which only consulted them on the Commission’s preliminary draft, did not ask for their opinion on the criteria proposed by the European Commission, which were not included in the preliminary draft. This is quite a surprise from the French government, which has always claimed that decisions concerning GMOs should be based on science.

The French government’s decision not to consult scientific experts is not original. The European Commission itself did not consult its experts at the European Food Safety Authority (EFSA) on the criteria it proposed for declaring plants equivalent. As the EFSA press service informed us, « The criteria proposed by the European Commission specifically for its proposal for NGT Cat 1 were developed by the EC itself ». It may well have based it on a 2022 EFSA opinion on the assessment of risks associated with the use of genetically modified plants through new techniques, as both EFSA and the European Commission have informed us. However, there has been no consultation of European experts on the criteria finally adopted and proposed by the European Commission.

The European Commission’s press service has confirmed to Inf’OGM that it has asked the EFSA for its opinion on criteria for a risk assessment. Paradoxically, as Inf’OGM detailed in another article, the conclusions of this opinion will ultimately be ignored by the European Commission since, unlike EFSA, the Commission will propose that no risk assessment be carried out [7].
What is the origin of the criteria established by the European Commission ? Perhaps it lies in the latest source of information the Commission has indicated to Inf’OGM, namely that « The Commission also collected and considered evidence and views provided by a large range of stakeholders and experts in preparation of the impact assessment ».

The year 2024 will see the continuation of the discussions begun in 2023 within the Council of Ministers and the European Parliament on the European Commission’s proposal. After negotiations between these political bodies and the European Commission, in what is known as a trilogue, a new legislation to deregulate GMOs may or may not be adopted. Indeed, the final decision on deregulation belongs to the European legislator. However, should this be the case, it will no longer be possible to claim that such a decision is based on « good science », so often invoked by governments and the European Commission.

References

[1] Anses, « Plantes NTG : analyse des critères d’inclusion dans la catégorie 1 proposées par la Commission européenne », December 21, 2023 (in french).

[2] Recital 2 of the proposal for a regulation presented by the European Commission on July 5, 2023

[3] Recital 14 of the proposal for a regulation presented by the European Commission on July 5 2023.

[4] For the Anses experts’ opinion criterion by criterion, see note 1, page 18 to 24

[5] Annex 1 of the proposal for a regulation presented by the European Commission on July 5, 2023.

[6] The Commission defines intragenesis as « a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool ». Recital 2 of the proposal for a regulation presented by the European Commission on July 5, 2023

[7] Eric MEUNIER, « GMOs : the Commission ignores its experts to reassure industry », Inf’OGM, 25 octobre 2023.