Category Archives: Regulation

Time to give NGTs a chance

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Marco Pasti grows corn, soybeans, wheat, barley, sugar beets, potatoes, some wine grapes and walnuts on his farm near Venice, in Italy. In addition to being a farmer, he is an advocate for science-based agriculture. Don’t miss his opinion piece written for the Global Farmer Network after the European Parliament vote on the New Genomic Techniques last February. After the EU elections next June, the path of the new regulatory framework will resume, which could mark a turning point “in favor of sound science – and possibly a major break from the mistakes of the past when Europeans treated crop innovation with skepticism and even fear.”

CRISPR plants – what the EU Parliament got right and wrong

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There is no doubt that this is good news: on February 7, the European Parliament approved the Commission’s regulatory proposal on New Genomic Techniques, covering also CRISPR plants. Some of the approved amendments (particularly the one on genetic modification of polyploid plants) have the effect of improving the text, others risk being a problem and should be reconsidered during the trilogue with member states (particularly the requirement to label all final products, even if they do not contain foreign genes). The European Parliament also brought in the issue of non-patentability of NGT plants, which would deserve to be addressed elsewhere. For more information, this is the position expressed on February 14 by European Plant Science Organisation (EPSO).

CRISPR crops – Italy fires the starting gun

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A CRISPR/Cas9-modified rice variety may be planted in a test field in northern Italy as soon as this spring after a government rule change introduced in 2023. A University of Milan team was the first research group in the country to apply for a field test under a law change that streamlines procedures for field trials of plants developed through genome editing or cisgenesis. With several other groups also planning proposals, a new wave of agricultural genetics in Italy could follow. [Please see the details in my article for Nature Italy]

A letter to Europe from CRISPR inventors and a thousand other scientists

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Dear Members of the European Parliament, 

In these times of climate crisis, biodiversity loss and renewed food insecurity, a scientific and evidence-based approach is essential in every respect. Now more than ever, we must rise above ideology and dogmatism. That is why we the undersigned turn to you and urge you to carefully consider the benefits of embracing New Genomic Techniques (NGTs) in your upcoming parliamentary decisions. As concerned citizens who believe in the power of science to improve our lives and our relationship with the planet, we implore you to vote in favour of NGTs, aligning your decisions with the advancements in scientific understanding. Conventional breeding for climate resilient crops (with cross-breeding of certain traits, subsequent selection and then backcrossing to remove undesirable traits) is too time-consuming. It takes years, decades even. We do not have this time in an era of climate emergency.  

[Here you can read the full text of the letter and subscribe to it]

Organic farming & CRISPR – the not so odd couple

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The New Genomic Techniques (NGTs) such as CRISPR are slowly rearranging the ranks in the debate on plant genetics and GM food. A few stakeholders that have always been hostile to GMOs have decided to open the door to the new opportunities coming from gene editing (in Italy, for example, the powerful farmers’ association Coldiretti has changed its mind). Others (e.g., Greenpeace, despite some isolated and courageous vanguards) have confirmed an ideological/cultural opposition, even in cases where the genetic intervention is so soft that the plants are concretely indistinguishable from those developed by conventional techniques. As for the galaxy of organic farming, it is standing still, yet something is moving. Don’t miss the article published in EUobserver by Lone Andersen and other organic farmers, who are calling on European institutions not to ban the new breeding techniques from their fields in the ongoing regulatory revision. “By encouraging the use of a limited share of the new NGTs in organic agriculture while preserving the non-GM status, the EU can further promote sustainable practices and reinforce its commitment to a greener future,” they write.

Hopes and worries in the CRISPR world

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Credit Bing Image Creator

The news of the week is definitely this: the first clinical trial with base editing (the CRISPR platform used to chemically change single DNA letters without double-strand breaks) hit the goal of lowering cholesterol in patients but raised questions about the risks (with two serious adverse events, including one death), as Nature reports.

But we also recommend reading two other articles. Nature Biotechnology takes a look at experiments using CRISPR to eliminate viruses that manage to hide from the immune system, such as HIV and hepatitis. While Genetic Literacy Project publishes an analysis of the problems that could cripple the new regulation on edited plants proposed by the European Commission and delay (even until 2030) the arrival of the first products on the EU market.

Edited crops in EU – Have your say

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The European Commission is collecting comments on the proposed regulation on New Genomic Techniques (NGTs) presented on 5 July. On this page you will find all the documents you need to form an opinion: from the criteria for establishing when a NGT plant is comparable to a conventional plant, to calculations on the costs of coexistence for organic producers (see in particular the Impact assessment report). The feedback received during the consultation period (8 weeks, extendable) will be summarised by the European Commission and presented to the European Parliament and the Council to feed into the legislative debate. In general, CRISPeR Frenzy appreciates the proposed regulation, especially for its focus on the promised benefits of NGTs in terms of environmental sustainability.

A brief guide to the messy Italian debate on NGTs

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There is great disorder under the heavens of new biotechnology. Judging by the Italian debate on genetic innovation in agriculture, it seems that we no longer know what to call what. We are waiting for the European Commission to present its proposal to regulate ‘new genomic techniques’ (NGTs) on 5 July (see the leaked draft here). But in the meantime, on 9 June, the Italian Parliament approved a regulation in favour of experimentation with ‘assisted evolution techniques’ (TEAs), which are the same thing. However, if you read the official wording (9 bis, drought decree law) this expression is missing: instead, it refers to the deliberate release into the environment for experimental purposes of ‘organisms produced by genome editing techniques through site-directed mutagenesis or by cisgenesis’.

Continue reading →

NGT-leaks: EC confidential proposal circulating online

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The European Commission’s proposal for an updated regulatory framework for New Genomic Techniques is due on 5 July, but someone leaked the confidential document online. In a nutshell, if the modification could also have been achieved naturally or by conventional methods, and the plant has the same risk profile as its conventional counterpart, it should be treated similarly to conventional plants and differently from GMOs (it would not require authorisation, risk assessment, traceability, labelling as GMO, but would be placed in a transparency register). For plants in which editing or cisgenesis has led to results that differ from conventional ones, the current GMO rules apply. You can read the Genetic Literacy Project’s explanation here.

Please note a couple of things environamental NGOs and organic producers should like: herbicide-tolerant NGT plants would remain subject to GMO rules, and all NGT plants would remain subject to the prohibition of use of GMOs in organic production.