Knock Knock: who’s there? – The Reform Of The Genetic Engineering Laws?

Genetic engineering. For some it’s the sleep paralysis demon, for others the holy grail. Granted, it’s not as dramatic. However, the gene scissor is not the only one separating. The topic is discussed heatedly across politicians, scientists and consumer advocates, and not just nationally. Only recently the pot has been stirred again by the decision of the EU-Parliament to approve relaxations for specific genetic engineering methods. But let’s start from the beginning…
The Status Quo of Genetic Engineering Laws – what currently applies

The Status Quo of Genetic Engineering Laws – what currently applies

Genetic Engineering Law – like so much else in the EU – is a construct of national and EU-standards. Until now the former are based on the so called “release-“ directive with the catchy name 2001/18/EG. Germany implemented this directive with the GenTG (Gentechnikgesetz). This law covers all genetically modified organisms whose genetic material has been altered in a way that does not occur under natural conditions through crossing or natural recombination. By definition, such a process also includes the increasingly popular methods of mutagenesis using gene scissors or the CRISP/R process. This involves deliberately inducing changes in the genetic material of an organism.

These types of procedures currently need a release authorization, or a request for approval in case the organism is supposed to be put on the market. This means long and complex processes, as well as a critical view of the general population.

As a small legal tidbit, I want to note here, that the strict regulations of the GenTG only apply to procedures in which targeted DNA changes are to be brought about. Classical methods of mutangenesis, where DNA-changes are caused by chemical treatment or radiation, only require variety approval according to the German Seed Marketing Act (Saatgutverkehrsgesetz). This is explained with the fact, that DNA changes using the classic methods are random and not deliberate like with the gene scissors or CRISP/R. However, looking at the intentions of the laws, which is the protection of humans and nature of the risks of genetically altered organisms, this result does raise eyebrows.

Excursus: Directive, Regulation, Recommendation – what abilities does the EU have? And who?

Everyone is always talking about recommendations, directives and regulations of the EU. But what does that actually mean? The EU has different tools to regulate matters legally. The above-mentioned directive is a legal act where the EU defines a specific goal for the member states to then achieve. As a result, directives do not apply directly and immediately to the respective member state, but the state must pass its own law that implements the objective of the directive. For this reason, the GenTG exists alongside the EU’s Deliberate Release Directive.

In contrast, the Regulation is a legal instrument by which the EU can directly impose binding legislation on the member states. This means that a national law of the member state is no longer required for the requirements set out in the regulation to apply. However, the member states usually have the option of enacting laws that supplement the regulation, as long as these do not conflict with the latter. One example of this is the GDPR for data protection. Its provisions apply directly to all member states. However, Germany also has the Federal Data Protection Act and even state data protection laws at state level.

But who is to blame for all the directives and regulations?

The EU Parliament is a directly elected body of the European Union and is responsible for legislation. It adopts legislation together with the Council of the EU on the basis of proposals from the European Commission.

What does the EU-Parliament want to change?

After what we have now learned, we also understand a little better why there is a directive at EU level and also the GenTG. Unfortunately, the status quo on our planet is now as follows: there are too many of us eating too much – especially meat – and emitting too many exhaust gases. Of course, this does not fully address the causes of climate change. But the fact is that pests and weather extremes are increasingly threatening our food sources due to climate change. This has also more or less clearly reached our legislative bodies in the EU. And this is where genetically modified plants come into play: because mutagenesis could make them more resistant to diseases or weather extremes. As a result, fewer resources and pesticides would have to be used to maintain them. In other words, a clear plus in terms of sustainability and food security.

Having said this, there was already movement in the EU Parliament in the middle of last year. The majority voted in favor of relaxing the regulations for plants modified with gene scissors or CRISP/R. They are to be considered plants of new genomic techniques (NGT) of category 1. As a result, there will be no complicated approval process and the plants will only have to be registered with the competent national authority. Furthermore, in the case of category 1 plants, only the seed must be labeled as genetically modified, not the plant itself. One consequence of this would be that end consumers would no longer know whether the food they buy has undergone a genetic modification process. The prerequisites for when a plant enters the category are complex. Essentially, it can be said that changes to the DNA sequence can be made if the NGT plants are equivalent to conventional plants.

After this announcement triggered protests not only from consumer and organic farming associations, but also from member states themselves, the EU Parliament has now further restricted the changes in a proposal in a new legislative resolution dated 24.04.24: Member states are now to be given more say after all by providing the relevant competent authority with a review procedure prior to an intentional release. Public access to information on the use of NGT plants is also to be created in a public database. A further innovation is that the processes used to produce genetically modified plants may not be patented. This is intended to counteract monopolization by large corporations and the crowding out of small farms on the market. This leaves only the registration of the new variety in accordance with plant variety protection. Finally, the Parliament is now proposing that food produced using the aforementioned genetic engineering methods should also be labeled as such in order to create more transparency for consumers. In its documents, the Parliament also talks about summarizing the directives in a regulation, with the consequence that this would then apply directly to the member states.

What implications does this have for research? And when can I expect it?

If the proposed changes are implemented, this will of course open up numerous opportunities for plant researchers. However, a final decision before the upcoming European elections in June seems unrealistic.

So it’s still a case of wait and see, drink tea and go and vote.

Lea Singson, FAIRagro Helpdesk (FZI Karlsruhe)