Exactly one year ago, the European Court of Justice (ECJ) ruled on genome editing. The ruling is controversial within the scientific community. Austrian research institutions, along with other European scientists, are demanding an amendment to the law. The researchers claim that the legislation is based on outdated scientific principles.

Genome editing is one of the new genetic engineering methods that enable targeted intervention of the genetic make-up of organisms. While genome editing in humans and animals is not yet an actuality due to ethical reasons, it has led to high expectations when it comes to the cultivation of plants. It is hoped that this will pave the way for the development of promising plant varieties. For example, the elimination of certain genes could make breeds more resistant to diseases and climate change-related drought. This would allow farmers to be able to safeguard high yields while at the same time reduce the use of chemicals and water.

Various methods are subsumed under genome editing. The most apt method for plant breeding is CRISPR/Cas9. Precise, fast and cost-effective, it is designed to replace standard processes based on chemicals or irradiation.

Far-reaching consequences

In this public statement, researchers criticize the judgment of the European Court of Justice in which CRISPR/Cas9-based breeds were classified as genetically modified organisms (GMOs). This classification has far-reaching consequences. It has become virtually impossible to carry out field studies and plant cultivations within the EU. Above all, however, this classification requires complex and expensive approval procedures that only multinational corporations are able to afford, according to the researchers’ arguments. They fear that there will be no more investment in research within the EU and that smaller farms will be discouraged from engaging in cultivation.

Obsolete directive

The researchers justify their critique with the fact that the ruling has been based on an outdated GMO directive from 2001. They demand that the legislation on genetic engineering must be updated. This should take into account the advances that have been made in genetic engineering, particularly in the field of targeted genetic modification of organisms (GMOs). In applications of genome editing, a differentiation has to be made in the following areas:

  • Genome editing which mimics natural mutagenesis processes;
  • Genome editing that requires more control;

CRISPR/Cas9 mimics natural mutagenesis processes. Not all areas of the genetic material may be edited without any restrictions. The researchers therefore equate this method with conventional plant cultivation methods involving gene modification induced by chemicals or irradiation. Conventional procedures are not covered by GMO legislation and are therefore exempt from regulation.

Supersedes time-consuming procedures

Conventional methods produce random variations in the plant genomes which lead to new genetic properties. Nevertheless, they require complex, time- and cost-intensive selection and backcrossing in order to be able to separate the new variations from hundreds of unwanted mutations, Ortrun Mittelsten Scheid, group leader at the Gregor Mendel Institute of Molecular Plant Biology (GMI), explains. Quote: “The new methods such as CRISPR/Cas allow precise cultivation whereby the same kind of positive genome modifications may be achieved without the associated genome damage”.

Indistinguishable

An additional problem is that subsequently, genome-edited breeds are no longer able to be distinguished from breeds arising from conventional methods. Which is why their import into the EU is possible without any problems. This is a matter that the legislature must address, explains James Matthew Watson, Head of Science Support at the Gregor Mendel Institute of Molecular Plant Biology (GMI). Quote: “There was recently an article on this in the Nature magazine about the difficulties faced by food testing laboratories.”

It is still difficult for scientists to understand why regulation differentiates between small mutations resulting from spontaneous errors in DNA replication and those resulting from CRISPR/Cas-based technology. This also comes to light in a recent policy paper on genome editing published by the Max Planck Center.

Opposing opinions

Nevertheless, opinions on genome editing differ – and reflect the controversy surrounding genetic engineering in general. The ruling of the European Court of Justice was praised by environmentalists. With regard to genome editing, genetic engineering is making its way through the back door.

Even in an ethically based discourse, genome editing is considered as problematic. Because there are too many unforeseen variables “which are still difficult to assess and will have to be studied in detail over the years”. (Source: gen-ethischesnetzwerk.de). In concrete terms, the geneticists warn against unintentional off-target effects, i.e. unwanted changes in the DNA in areas where they were not intended.

An effect that Watson has acknowledged yet also mitigates: “It is true that genetic scissors can cause so-called off-target mutations in other areas. However, compared to radiation or chemical methods used in conventional cultivation, these are (1) more predictable, (2) significantly less, and (3) can in principle also be discovered by sequencing the entire genome.”

The signatory institutions:

This public statement was signed by the following institutions: Austrian Institute of Technology (AIT), The Institute of Science and Technology Austria (IST), the University of Natural Resources and Applied Life Sciences Vienna (BOKU) as well as the Gregor Mendel Institute for Molecular Plant Biology (GMI) and the Research Center for Molecular Medicine (CeMM) of the Austrian Academy of Sciences ((ÖAW)).