The Court of Justice of the European Union has just ruled that gene-edited plants and crops are subject to the same tough regulations as genetically modified organisms (GMOs). The ruling stands apart from a recent U.S. Department of Agriculture statement claiming gene-edited plants are notably different from more comprehensively altered GMOs.
The big distinction this ruling hinges on is the difference between mutagenesis and transgenesis. Traditionally, regulated GMOs are a product of transgenesis, where a foreign gene is introduced into an organism or plant. This can be used to generate crops that can, for example, produce natural pesticides to protect against harmful insects. Products of transgenesis are notable in that they are entirely unnatural species that could never appear organically in the environment.
Mutagenesis, on the other hand, involves gene-editing an organism to remove or alter specific genetic material in an organism. For example, a recent study from the University of Illinois increased the expression of a single gene in tobacco crops resulting in them needing 25 percent less water to grow. Mutagenesis is a fundamentally natural process but recent genetic editing technologies such as CRISPR have allowed scientists to artificially stimulate and control this general evolutionary process.
"Mutagenesis is a natural phenomenon responsible for the genetic diversity that can been seen in all living organisms," explains Nicola Patron, head of synthetic biology at the Earldom Institute. "Humans have used different technologies to induce mutations in plants to increase genetic diversity and improve the agronomic qualities of crops for almost a century; the same outcomes can now be achieved using faster, more efficient and precise mutagenesis methods."
The latest EU court decision rules that organisms produced by mutagenesis will be subject to all regulations and obligations under the GMO Directive introduced in 2001. This GMO regulation was designed to add significant oversight and controls over how genetically modified organisms were introduced into the environment. At the time, the EU ruling explicitly left out organisms subjected to mutagenesis from this directive, but recent gene-editing technologies have brought the issue back to the attention of the courts.
The new EU Court ruling ultimately concluded it, "considers that the risks linked to the use of these new mutagenesis techniques might prove to be similar to those that result from the production and release of a GMO through transgenesis, since the direct modification of the genetic material of an organism through mutagenesis makes it possible to obtain the same effects as the introduction of a foreign gene into the organism (transgenesis) and those new techniques make it possible to produce genetically modified varieties at a rate out of all proportion to those resulting from the application of conventional methods of mutagenesis."
Greenpeace quickly responded to the ruling, applauding the court for protecting both the environment and the health of its citizens. Greenpeace's EU food policy director, Franziska Achterberg states, "These requirements exist to prevent harm and inform consumers about the food they eat. Releasing these new GMOs into the environment without proper safety measures is illegal and irresponsible, particularly given that gene editing can lead to unintended side effects."
The majority of scientists, on the other hand, have responded with shock and anger at the EU ruling, claiming this decision is both scientifically unfounded and will result in a stifling of development and innovation in Europe. Various reactions have labeled the ruling, "misguided", "retrograde", "a backward step", and "a sad day for European plant science."
Nick Talbot, Professor of molecular genetics at the University of Exeter says, "To classify gene edited crops as GMOs and equivalent to transgenic crops is completely incorrect by any scientific definition." And Wendy Harwood, from the Department of Crop Genetics at the John Innes Centre suggests it will dramatically limit the EU's ability to engineer food to adapt to the growing needs of its population.
"The European Court of Justice opinion that organisms obtained by mutagenesis are GMOs and therefore subject to the obligations of the GMO directive is a disappointing setback for the use of valuable new technologies in crop improvement," says Harwood. "This decision could have major negative impacts on our ability to respond rapidly to the challenges of providing sufficient, nutritious food under increasingly challenging conditions."
The EU decision potentially overrules recently local decisions in both Germany and Sweden stating that gene-edited plants should not be classified the same as GMOs. It also stands apart from a statement made in April by the U.S. Secretary of Agriculture Sonny Perdue, clarifying his agency has no plans to institute a regulatory framework like this on gene-edited plants and crops in the United States.
While regulatory conditions in the United States are a little more fragmented than the EU, both the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have no clear ruling on this specific matter. An FDA spokesperson has suggested the agency is considering the matter, but currently there is no oversight or control into mutagenesis by any means in the country.
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