'New plant breeding techniques' focus on developing new seed traits within a given species through genetic engineering. A troubling question for policymakers is whether these techniques should fall under GMO legislation.
In 2007, the European Commission was asked by national authorities to answer an unusual question. As scientific and technical developments in biotechnology developed, regulators wondered whether so-called new plant breeding techniques such as "reverse breeding" or "synthetic genomics" should fall under the scope of EU GMO rules.
As it often does in such cases, the Commission responded by setting up a working group of experts. Almost ten years on, a decision is finally in sight, with a legal opinion due by the end of the year.
“The European Commission is carrying out a legal analysis of a group of new plant breeding techniques, in order to evaluate whether they fall under the scope of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and Directive 2009/41/EC on the contained use of genetically modified micro-organisms,” an EU source confirmed to EurActiv.
The techniques under consideration come with barbarous names: "oligonucleotide-directed mutagenesis", "zinc finger nuclei" and other similar nuclei technologies, "cisgenesis", "intragenesis", "grafting", "agro-infiltration", "RNA-dependent DNA methylation" and "reverse breeding".
On the regulatory side, the Commission's work involved the elaboration of a specific expert report between 2009 and 2012. Guidance was also received from the The European Food Safety Authority (EFSA) in Parma, which has issued two opinions - on cisgenesis/intragenesis and Zinc Finger Nuclease 3 - in terms of the risks they might pose for human health or the environment.
A formal Commission decision - an "interpretation document" in EU jargon - has now been announced for the end of 2015. And the consequences could be huge for the companies developing the new techniques.
"Biotechnology companies and plant breeders are particularly concerned about the legislative uncertainty of the GMO classification of new plant breeding techniques," notes a 2011 report by the European Commission's in-house scientific body, the Joint Research Centre.
"Regulatory costs for plants classified as GMOs are much higher than those for the registration of non-GMO plants, and public acceptance is lower," the report states.
Aware of the political implications of the upcoming legal opinion, some policymakers are already trying to downplay the significance of the document.
“It’s not an issue of political nature. On the contrary, it’s strictly legal," a European Parliament source told EurActiv.
'Crucial' for plant breeding sector
New plant breeding techniques are seen as a promising new field for the agri-food sector. The Commission's JRC report says they are even "necessary to meet the challenges of global changes such as population growth and climate change".
On the industry side, the matter is clear: New plant breeding techniques should not be assimilated to GMOs.
Garlich Von Essen, the Secretary General of the European Seed Association (ESA), told EurActiv that the vast majority of new plant breeding techniques did not lead to genetically modified plants and should therefore not be considered as such.
“ESA shares and fully supports the findings of the experts working group made up of representatives of member states authorities,” he said, adding that most of the techniques in question were just very targeted and more precise mutagenesis techniques which are "applied within the plant species".
Crucially, Von Essen stressed, "no foreign DNA is present in the resulting plants". Plants obtained by these new techniques might also have developped naturally by chance mutations, he said, or through an application of classical mutagenesis.
“A distinction of plants obtained by either a new breeding technique or a classical mutagenesis is, therefore impossible, a fact also underlined by the experts report. Consequently, mutagenesis generally is exempted from GM legislation, not only in the EU but worldwide. This exemption should also cover the new gene-editing techniques," he noted.
According to Von Essen, it is difficult to judge what approach the Commission’s health directorate (DG SANTE) will ultimately take. But he expressed hope that it will follow the experts. “Not least as these techniques are of critical importance for the European plant breeding sector for the coming decades," he said.
According to Von Essen, new breeding techniques hold potential across all species. They are also affordable for the vast majority of smaller and medium-sized breeding companies but could soon become too costly to develop if they were to fall under the scope of GMO legislation.
“Should SANTE out them in one box with GMOs, they will become unaffordable to use for most companies," Von Essen said.
On the other side of the argument are the usual suspects represented by the Greens and their leading anti-GMO figure, French MEP José Bové.
To Bové, new plant breeding techniques are just another attempt at selling GMOs to Europeans via the back door. “We oppose all these biotechnology techniques because making plant varieties resistant to herbicides is dangerous and harmful to health and the environment in the short, medium and long term," Bové told EurActiv.
Bové, who is a member of the Agriculture and Rural Development Committee of the European Parliament, said that in France and other European countries, herbicide-resistant sunflower and rape varieties were starting to be used without ever having been properly tested.
“The fact that they are not considered as GMOs has allowed the agro-chemical seed companies to avoid the otherwise long and uncertain certification process: they appear to have learned their lesson from the GMO debate," he noted.
Bové added that the executive’s ultimate decision was as much political as it was legal or technical. The deicsion process itself is subject to criticism, he said, because it is happening within an exclusive group of scientific experts.
“By limiting the debate strictly to the technical aspects (a debate in which the Commission’s only engagement appears to be the announcement of a legal opinion in the coming weeks), attention is being deflected from the problem in order to avoid a truly democratic debate on the development of these techniques and their consequences for health and the environment, and thus spare the seed companies a repeat of the difficulty they experienced over GMOs."
As with GMOs, the scientific debate on new plant breeding techniques is complicated by economic considerations, where patents play a central role.
By 2011, a total of 84 patents related to new breeding techniques were identified, most of which were filed during the last decade, the JRC report notes. The majority of patent applications came from the USA (65%), followed by EU-based applicants (26%). A vast majority (70%), came from private companies.
The 1998 Biotech Directive grants protection of intellectual property rights over biotechnological inventions, and clarifies which inventions are patentable or not, on ethical grounds.
But policymakers in the European Parliament are usually suspicious of anything to do with patents over lifeforms. The debate last surfaced in 2013, when Parliament passed a biopiracy law, requiring industry to compensate indigenous people if it makes commercial use of their local knowledge, such as plant-based medicines. MEPs have also consistently stressed the importance of the "precautionary principle" when applying novel techniques for food production, underlining a high degree of suspicion within the Assembly.
Scientists call for regulatory reform
Meanwhile, the scientific community has called for a thorough review of EU legislation in order to avoid confusing GMOs with new plant breeding techniques.
"One immediate consideration for EU regulators is to confirm that when plants do not contain foreign DNA, they do not fall within the scope of GMO legislation,” said a report by the European Academies Science Advisory Council (EASAC), published in 2013.
Anne Glover, the EU's former chief scientific advisor at the time, agreed, saying Europe should not miss the opportunities offered by emerging plant breeding technologies.
“We shouldn't make the mistake of regulating them to death as we have done with GM,” she told EurActiv.