In 2001, the European Parliament passed a law known as the GMO (Genetically Modified Organism) Directive, which allows any of the 28 member states of the European Union to implement a blanket ban on the growth of GMO crops or import of GM organisms within their borders. But with the advent and rapid rise of CRISPR gene-editing technology, the definition of what is and what is not a GMO has gotten fuzzy. Scientists were hoping the EU restrictions on GMOs would not apply to crops created through CRISPR gene editing, but Arthur Nelson at The Guardian reports the Court of Justice of the European Union has weighed in on the issue, ruling that gene edited crops are also classified as GMOs and subject to the same stringent regulations.
The ruling comes after the French agricultural trade union, Confédération Paysanne and a consortium of other groups asked the court to interpret the GMO Directive in light of the new emerging technologies.
When the GMO Directive was written, it was aimed at GMOs produced using transgenesis, in which a gene from another organism is inserted into the genome of a plant or animal, Ewen Callaway at Nature reports. "Roundup ready" corn, which contains genes from a bacteria resistant to the herbicide glyphosate (commercially known as Roundup), is an example of such an organism. The controversial plant can survive being doused by the herbicide while the weeds around it cannot.
CRISPR technology also manipulates DNA, but in a much more targeted way. A bacteria is given a “mugshot” of a gene or stretch of DNA which it searches out, then it uses an enzyme—in many cases one called Cas9—to snip that DNA out of living cells, tweaking or disabling certain genes.
Proponents of CRISPR argue that it is very different from transgenic crop modification, since it does not add foreign material to the genome. Instead, they say CRISPR works with what’s there, mimicking the natural process of mutagenesis, in which DNA changes spontaneously over time, with some mutations resulting in new traits in plants or animals. In fact, a decades-old technique called mutation breeding, in which seeds are exposed to radiation and other processes that speed up mutations, is exempt from the EU’s GMO Directive.
In January, the court seemed undecided, with an advocate general in the European Court of Justice releasing a 15,000-word document that seemed to argue both sides, but gave some hope to scientists that CRISPR would be considered mutagenesis. The new ruling, however, classified gene-editing as a genetic modification covered by the directive.
“It is an important judgment, and it’s a very rigid judgment,” legal scholar Kai Purnhagen of Wageningen University in the Netherlands tells Callaway. “It means for all the new inventions such as CRISPR–Cas9 food, you would need to go through the lengthy approval process of the European Union.”
For crop researchers and scientists, the ruling is a big blow. While they will continue to do research on gene-edited crops in the lab, they argue that commercial and public support for the research will start to dry up, since no one wants to invest in crop research that will never make it to market.
Nelsen reports that environmental groups like Greenpeace have already called for Belgium, Sweden and Finland to halt trials of CRISPR crops and for the U.K. to stop field trials of the oil seed camelina that had been edited to produce Omega-3 fatty acids found in fish oils. It has geopolitical consequences as well. Eric Niler at Wired reports that researchers are working on gene-edited crops in several African nations, trying to produce new varieties of cassava, corn and sweet potatoes. The law would prevent the sale of those products in the EU, which is the continent’s largest trading partner.
“These new ‘GMO 2.0’ genetic engineering techniques must be fully tested before they are let out in the countryside and into our food,” says Mute Schimpf, a food and farming campaigner at Friends of the Earth Europe, one of the anti-gene-editing groups in the court case. “We welcome this landmark ruling which defeats the biotech industry’s latest attempt to push unwanted genetically modified products onto our fields and plates.”
Many scientists, however, are quite unhappy. Sarah Schmidt of the Heinrich Heine University of Düsseldorf tells Erik Stokstad at Science that the ruling is “the death blow for plant biotech in Europe." Since the cost of getting a crop through the regulatory process would take years and about $35 million, she says it will price universities, small biotech startups and non-profits out of biotech, leaving the industry to large multinational corporations.
“This proves how stupid the European system is for regulating GMOs,” Stefan Jansson, professor of plant physiology at Sweden’s Ümea University, tells Niler. “Many of us have tried to change things in last 10 years with meager success. When it comes to things like this, people listen to organizations like Greenpeace more than they listen to scientists.”
Niler reports that in the United States, the government has ruled that gene-edited crops are identical to those produced via the traditional process of cross-breeding and don’t pose any health or environmental threats. Soon, GE flax, wheat and soybeans, among other products, are expected to reach the U.S. market.