The European Commission has shelved a legal opinion confirming that a new breed of genetically modified organisms (GMOs) must undergo rigorous safety testing and labelling.

This paradoxical decision – in effect saying that organisms whose genes have been altered using certain novel technologies are not, in fact, genetically modified – follows intense lobbying by the US government.

Internal Commission documents and correspondence obtained by NGOs under freedom of information law reveal that US representatives pushed to exempt plants and animals produced through gene-editing and other new techniques from existing EU GMO rules.

The US pressure focussed on potential barriers to trade from the application of EU GMO law. It appears the US wants the EU to drop health and environmental safeguards on GMOs to pave the way for the Transatlantic Trade and Investment Partnership (TTIP) agreement. The next round of TTIP negotiations starts on 25 April 2016 in New York.

In advance of a meeting with DG SANTE’s deputy director-general Ladislav Miko, on 7th October 2015, the US mission to the EU said “it came to their attention” that the Commission’s legal opinion was going to classify the ODM gene-editing technique “as a GM technique”. The US mission warned DG SANTE that this would be “another blow to agriculture and technology”, according to a Commission briefing.

Civil society organisations, small-scale farmers and the organic sector have called on the Commission to apply EU GMO law to all products of genetic engineering, including new breeding techniques.

However US companies are heavily involved in gene-editing. For example Cibus has already brought a herbicide-resistant oilseed rape engineered through ODM to the US market. Dow Chemicals and DuPont, two US companies that recently merged into DowDuPont, also have a strong interest in gene-editing, as documented by their recent patent applications in the field.

‘Gene editing is genetic engineering!’

The Commission’s decision transparently violates the EU’s own laws on GM crops and foods that require case-by-case risk assessment, detectability and labelling. GMOs are defined as any organism, with the exception of humans, “in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating or natural recombination”. Gene-edited plants and animals should therefore be covered by the law

But in the US, GMOs are not systematically tested and can even be placed on the market without any form of testing. Labelling is not required although it soon will be in the state of Vermont. Gene-edited plants and animals are mostly unregulated. For example, US regulators ruled that Cibus’ SU Canola is exempt from regulation.

“The Commission must recognise that gene-editing is genetic engineering”, said Greenpeace EU food policy director Franziska Achterberg. “It must come out of the bushes and reassure EU citizens that it won’t allow the GM industry to bypass rigorous safety tests and labelling. There are fundamental issues of public trust and transparency at stake, and the Commission should act accordingly.”

Nina Holland, researcher for Corporate Europe Observatory, added: “The biotech industry has waged an under-the-radar campaign to get new GM products absolved from GM regulation. The TTIP negotiations are seen by industry across the board and the US government as the perfect opportunity to block EU processes that are supposed to protect public health and the environment. The regulation of new GM techniques is a case in point.”

Greenpeace trade expert Juergen Knirsch warned that the Commission’s cave-in to US pressure was a harbinger of more and worse to come:

“If TTIP is agreed, the US government will always get its way. In fact, the EU will progressively weaken its standards and safeguards to suit the US, and any plan to better protect our environment and health would be neutralised before it hits the democratic scrutiny of the European Parliament.”

The new techniques: very clever, but poorly understood

Most gene-editing techniques use enzymes to cut parts of the genome’s DNA, after which the cell’s repair mechanisms ‘repair’ the break – but in the process insert, replace or remove bits of DNA. Because the technique is not 100% reliable, unintended DNA cuts or other gene alterations can also occur, with unknowable consequences.

The techniques in question are listed on the Commission website under the industry-coined heading ‘New Breeding Techniques‘ and include zinc fingernucleases (ZFN), transcription activator-like effector nucleases (TALENs) and the clustered regularly interspaced short palindromic repeat (CRISPR) systems.

Another gene-editing technique involves the introduction of short strands of synthetic DNA that trigger cells to modify their DNA to match the introduced fragments. This technique is known as oligonucleotide directed mutagenesis (ODM).

The gene-editing process is not well understood, and can result in negative effects on the environment, and human and animal health. As little is known about how these techniques actually work, it is difficult even to identify potential hazards.