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German ministry warns on risks of new GM products


Commission representative expects they'll be traceable and labelled. Claire Robinson reports on landmark Brussels conference

A conference on "GMO Regulation for genomic techniques: Environmental and consumer protection aspects" was hosted by the German Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection, in Brussels on 13 June. Speakers addressed the European Commission's proposal to weaken the regulations around certain types of new GMOs.

The conference featured memorable presentations by several speakers, including:
* The German environment minister, who delivered evidence-based warnings on risks to health, the environment, and the organic sector from new GMOs.
* A European Commission official, a proponent of deregulation who nevertheless made important concessions on labelling and traceability of new GMOs.
* A researcher who described her findings on the detection of new GMOs.

German environment minister

Steffi Lemke, the German environment minister, emphasised that there is no need to regulate new GMOs differently. But she said that if new regulation is introduced, we need risk assessment and mandatory labelling. She warned that that new GM techniques have unintended effects, that new GM products may pose risks for health and the environment, and that the claimed benefits are not proven: "There is a high risk of greenwashing." 

Commenting on the Commission's belief that new GMOs could have benefits for sustainability, Steffi Lemke said that claims of sustainability can only be considered if risks to health and environment are first ruled out. She also cautioned that new GMOs could threaten the EU target of making 25% of farming organic by 2050. She said that to address food and farming problems, "we need solutions that don't expose us to additional risks".

EU Commission

Dr Klaus Berend, acting director of the European Commission's health unit DG SANTE, objected to the term "deregulation" to describe the Commission's initiative, preferring "tailored framework" and "proportionate" risk assessment. He claimed that new GMOs could reduce our dependency on imports, pesticides, and fertilisers, but that they must only be used provided they are safe (though he didn't say how this would be established if the requirement for risk assessment was reduced or eliminated) and bring benefits to society as a whole. He cited gene-edited tomatoes designed to be resistant to fungal diseases and potatoes designed to have less of the cancer-causing chemical acrylamide when fried. 

He said that consumers' right to choice must be respected and that the precautionary principle would continue to be the guiding principle in designing any new regulatory system.

Dr Berend said new GM techniques would benefit small and medium-sized companies (a common myth that has been debunked) and help farmers transition to sustainability. He skated over the issues of liability for contamination and patents. New GM techniques and products are patented and the patents are controlled by the big agribusiness giants. When questioned, he stated that the topic of patents was important and needed to be looked into. 

On the crucial question of labelling, he said, “I would expect that the label refers to NGT” (new genomic techniques, the Commission's term for new GMOs). Labelling would be a welcome concession, albeit there would be no mention of the better known term “genetically modified”.

Dr Berend insisted that the Commission's plans were fully aligned with the European Court of Justice ruling. (This ruling stated that new GM products were GMOs and must be regulated as such, given that the risks might prove similar to those of older-style GMOs.) He said that the EU would not fully deregulate new GMOs and that unlike in Brazil, there would always be an authorisation process. 

He said that the Commission would come up with a new legislative proposal (or a proposal for no action, which now seems highly unlikely) in the second quarter of 2023. The Council and Parliament would have the final word on whether the proposal becomes EU law.

Prof Sarah Zanon Agapito, NORCE researcher

Prof Sarah Zanon Agapito of the Norwegian government's research institute NORCE described her investigations into detection methods for new GMOs in her research programme, FOODPRINT. 

Prof Agapito raised the possibility that some gene-edited products might have unique "fingerprints" that could enable their detection. She said the key is not to rely on looking for a single transgenic "tag", as with older-style GMOs, but also to look in other parts of the genome for other specific sequences that mark out any given gene editing "event". 

In the Q&A session following the presentations, Dr Berend correctly pointed out that detection of new GMOs was not just a matter of laboratory techniques: It can also rely on the documentation trails used in blockchain technology. GMWatch points to the example of organically produced products, which are verified not by lab tests but by document trails. 

Prof Agapito said that in her home country of Brazil, the government has deregulated new GM plants that do not contain transgenes (foreign genes), but transgenic methods were still used in gene editing to insert the CRISPR/Cas editing tool and transgenic material may still be present in the final commercialised product. She said that all that a developer has to do in order to release a new GMO is send a letter of notification to the regulator stating that transgenic material is not present in the product. They claim that they have removed the transgenic material by backcrossing with the non-GMO parent plant, but they don't have to provide experimental data to prove it.* 

However, her own analyses contradict these claims. She said that certain new GM products that still contain transgenic material have been wrongly deregulated under this system and should fall under the GMO regulations. She emphasised the importance of using long-read whole genome sequencing in looking for unintended mutations – something that most GMO developers fail to do. Instead they use short-read sequencing and consequently miss many mutations and genomic rearrangements. 

In agreement with Prof Agapito, GMWatch has also called for long-read whole genome sequencing to be used in screening for unintended mutations in gene-edited products.

Prof Agapito warned about “environmental genetic engineering”, meaning new methods by which the genetic engineering process takes place in the open. Two products made with these techniques have been allowed in Brazil already.

A representative of the seed industry lobby group Euroseeds asked Prof Agapito how she is able to distinguish mutations arising from gene editing from those that happen naturally or through chemical mutagenesis techniques, which are exempted from the requirements of the EU GMO regulation. Prof Agapito replied that she searches for multiple targets in any given gene-edited GMO, such as a combination of two mutations known to be characteristic of the GMO.

Dr Christiane Paulus, director general for Nature Conservation at the German environment ministry

During the panel discussion after the presentations, Dr Christiane Paulus, director general for Nature Conservation at the Ministry, agreed with environment minister Steffi Lemke that we cannot say that new GM products pose lower risks than older-style GMOs. She said all such products should be subjected to an assessment of risks to ecosystems and biodiversity before they are marketed. For example, a new GM drought-tolerant crop could place more stress on the environment. She said coexistence was not possible, especially when it came to GMOs that are "made" in the field by spraying gene-editing tools onto crops, such as the two products described by Prof Agapito that have been deregulated in Brazil.

Isabelle Buscke, German Federation of Consumer Organisations

Isabelle Buscke of the German Federation of Consumer Organisations pointed out that of course companies know how to identify their gene-edited varieties, or they would be unable to protect their patents.

She said that EU food law provides for free and informed choice. She added that traceability is indispensable in case adverse effects appear later, so that companies can be held to account for potential damage. Labelling is a key tool, both for consumers who are open to buying new GM products and those who are against. She reported the findings of a BEUC [European Consumer Organisation] survey in 2020, which showed that consumers want environmentally friendly and GMO-free food, as well as a German survey which showed that well-informed and young consumers reject GMOs. She said the Commission’s objectives "can be achieved without touching the legal framework".

Mute Schimpf, Friends of the Earth Europe

Mute Schimpf of Friends of the Earth Europe said that they are making a very modest demand on new GMOs – they don’t say "ban them", but only "keep them regulated". If they aren't regulated, she said there is a risk that untested GMOs will end up contaminating the natural world. She criticised the Commission for emphasising the potential of new GMOs and downplaying the risks. She added that it was not possible to assess the sustainability of a product that doesn't exist yet.

Martin Häusling, Green MEP

Martin Häusling, a German Green MEP, said that the Commission was trying to give answers to questions that nobody but the GMO developer companies are asking. Farmers and consumers don't want to change the GMO regulations. Around 650 million Euros have been spent on GMO research, but none of that has gone on studies on risks or detection methods. He added that it was easy to eat healthily and that we need to focus on promoting agroecology, not on genetically engineering products to try to make them healthier. He said that the GMO industry was afraid to label new GM products as they know people won't buy them.

Pascal Durand, MEP with the Renew Party

Pascal Durand, an MEP with the Renew Party, said that his own stance didn't reflect that of his party. He said deregulation of new GM techniques could threaten our relationship with nature and consumers' health, as well as leading to increased corporate domination of markets through patents. He wants new GMOs to continue to be subjected to the GMO regulations.

Anja Hazekamp, MEP with the Party for Animals

Anja Hazekamp, a Dutch MEP and a member of the Party for Animals, dismissed the promises made for new GM products, saying, "We've heard it all before" with the first generation of GMOs. She said they offered no benefits, but only threats, and warned that deregulation of new GMOs will have "disastrous effects on animals".

Contrast to UK "debate"

The Brussels event was in stark contrast to the House of Commons "debate" on the second reading of the UK government's Genetic Technologies Bill two days later on 15 June. With a few notable exceptions, the discussion was dominated by GMO boosters who made demonstrably false and ill-informed claims about new GM techniques. These included claims that the new GM techniques that the government wants to deregulate are not GM at all (we're looking at you, environment secretary George Eustice) and that gene-edited GMOs don't involve the insertion of transgenes (Katherine Fletcher MP, who made a big deal of her scientific background before coming out with this statement, which has been roundly debunked, not least by Prof Agapito in her Brussels presentation). 

At the Brussels event, the politicians who spoke had done their homework and understood what they were talking about, while the scientists had genuine expertise in their topics. We in the UK can only dream of such a well informed public debate.


* To search for plasmid sequences from the plasmid vectors used to carry the gene-editing tool into the plant cells, developers use PCR-based methods. To search for off-target mutations from the gene editing process, they use computer predictive software. Neither system, alone or in combination, is adequate to prove that no transgenic material is present in the final gene-edited product.


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