Warns of dangers of unexpected toxins and allergens, nutritional problems. Report: Claire Robinson

An expert opinion on the risks of new GM plants from the French National Agency for Food, Environmental and Occupational Health Safety (ANSES) has finally been published after delays led to repeated accusations of censorship (see below). Its devastating findings threaten to derail the attempts to weaken the regulations around new GM plants.

In the newly published report, ANSES calls for new GM plants to be assessed for health and environmental risks on a case-by-case basis. It says it is "important" to set up a monitoring plan after each market launch, both for the environmental impact of these new GMOs and their socio-economic effects.

The ANSES report's authors carried out around ten case studies (rice with reduced height, wheat with lower gluten content, herbicide-tolerant potato, grapevine resistant to grey rot, tomato with high amino acid content, etc.) and considered the possible risks that these NGT plants (plants produced by new genomic techniques, like CRISPR/Cas) pose to health and the environment.

The group of scientists noted that "certain potential risks appear repeatedly in these case studies" and that "These include risks linked to unexpected changes in the composition of the plant, which could give rise to nutritional, allergenicity or toxicity problems, or medium- and long-term environmental risks, such as the risk of gene flow from edited plants to compatible wild or cultivated populations."

GMWatch is pleased to see ANSES's acknowledgement of the health risks of new GM plants, which have been virtually ignored, or simply denied, by the pro-deregulation elements of the European Parliament and completely brushed aside in the UK.

The experts draw attention to the fact that the wide diversity of plants that can be modified using NGTs could increase the risk of modified genes being transferred to other species. They also note the risk of disrupting interactions between animals and NGT plants, particularly in the case of pollinating insects.

Taking CRISPR/Cas as the most widely used new GM technique, ANSES points out that the precision with which these 'molecular scissors' operate is not perfect: Numerous studies report 'undesired off-target effects', i.e. unintended modifications to the genome of NGT plants. ANSES recommends paying particular attention to these effects, characterising the entire area of the genome affected and justifying the absence of risks associated with these collateral modifications.

For the risk assessment of gene-edited plants, ANSES recommends:

- the development and adaptation of proteomic and metabolomic techniques for comparative composition studies under real conditions, after field cultivation (GMWatch has also repeatedly recommended these molecular analyses for new GM plants, in order to detect unexpected compositional changes resulting from the GM processes used to develop the plants);
- the determination of the main known allergens in the plants under consideration using quantitative LC-MS/MS (liquid chromatography with tandem mass spectrometry) techniques;
- depending on the species, measurement of the levels of toxic, genotoxic or anti-nutritional compounds known to be expressed;
- better consideration, in the environmental risk assessment, of the cumulative long-term effects and agri-environmental characteristics of NTG plant cultivation.

ANSES also notes that these recommendations could also be applied to the assessment of transgenic GM plants. In GMWatch's view, this is a wise suggestion that could greatly improve current regulation.

Unlike the UK GMO regulatory authorities, ANSES's experts have actually read and considered some precautionary reviews from the peer-reviewed scientific literature, which warn that NGT plants could have unintended effects on health and the environment. They summarise the findings of these reviews in an unbiased manner and take them seriously.

Another excellent suggestion is that the 90-day animal feeding study is mandatory for NGT plants, though it is unclear from ANSES's text whether this only applies to plant species known naturally to contain toxic or anti-nutritional substances, or all NGT plants. Given the unpleasant surprises that can arise with GM plants in animal feeding studies and the known unintended mutational effects of new GM techniques, GMWatch recommends that all NGT plants are subjected to these studies.

In sum, ANSES is proposing a case-by-case assessment for NGT plants, depending on the modifications made, any unintended effects detected, the nature of the modified plants, and so on. The agency says it "shares the experts' observation" that "some of the risks identified [for NGT plants] are similar to those already identified for [the first-generation GMOs], but that exposure to these risks could increase as the use [of NGTs] develops and the size of the market for these plants increases, especially as work is underway on widely distributed plants [fruit, vegetables, etc.] that are not currently affected by transgenesis".

Another major aspect of the report concerns the socio-economic impact of NGTs. The experts stress the importance of "adapting the current regulatory framework for intellectual property rights" on NGT plants. Depending on the nature of these rights (patents, etc.), the adoption of NGTs could lead to "imbalances between economic players in terms of value sharing". They state, "The impact of the development of NGT-derived plants on the concentration of the plant breeding and seed sector is a major issue that the public authorities should be vigilant about."

The experts note, however, that each sector would be affected differently by the introduction of new GMOs in Europe, particularly because of the "potential difficulties" of coexistence between the GM, conventional and organic sectors.

Political pressure

Although ANSES's report was only published on 5 March, according to an article published earlier in the day in Le Monde by Stéphane Foucart, it was finalised as long ago as 11 December 2023. The formal opinion of ANSES, based on this report, was signed on 22 January by its director General Benoît Vallet, and immediately forwarded to the French government. ANSES had planned to publish the report and opinion at the beginning of February, but sources close to the matter said that publication was blocked due to "political pressure".

Foucart writes in Le Monde that the date was important because the agency's expert opinion was meant to inform the voting decisions of MEPs, who voted on 7 February to weaken the EU's regulations around new GMOs, subject to certain conditions. According to Foucart, "Despite this vote, the European Commission's plan to relax the regulations is now at a standstill due to a lack of agreement between the Member States, and has been postponed until the next parliamentary term [note: GMWatch understands that the Belgian Presidency of the Council of the European Union is still trying to push the proposal through in this term]. As of Tuesday 5 March, ANSES had still not made anything public, giving no explanation for its procrastination, making no comment and assuring us that everything will be published shortly." The report was only finally published after Foucart's article made clear the nature of its content – on the basis of a leaked copy of the report.

Foucart points out that ANSES's opinion is in direct opposition to the position on deregulation defended by France in Brussels and to the majority position expressed by MEPs from Renew (France's governing party) in the European Parliament. That position was to exempt many NGT plants from health and environmental risk assessment, traceability and labelling requirements.