The European Court of Justice's decision on mutagenesis questioned by expert researchers.

The European Court of Justice recently came up with a ruling on how to interpret the use of mutagenesis in an existing GMO directive. The European Court of Justice believes that mutagenesis, except when using toxic chemicals or radiation to introduce random and multiple mutations, should be regulated under the GMO Directive. They want to distinguish between crops with the same type of mutations and regulate crops where the mutation is introduced with full control. Swedish industry and Swedish researchers are questioning the judgment and point out many shortcomings and factual errors. "It is obvious that scientific facts have been insufficiently gathered and scrutinized " the researchers argue.

Mutations occur when a DNA strand is damaged and the cell's own repair mechanism mends the damage so that the end result is different from what it looked like to start with. The mutations thus arise through the organism's own system; regardless of whether it is a spontaneous mutation, a mutation with traditional methods, to which the EU court refers to having shown a history of safe use, or new improved methods of refinement. Since spontaneous mutations as well as mutagenesis through traditional methods have demonstrated safe use, it cannot be interpreted otherwise than that all mutagenesis involving a breach in the DNA strand and mutation induced through the organism's repair system do not cause any safety problems.

It is not possible to distinguish in a crop the technique used for mutagenesis, and thus the exception in the GMO Directive must apply regardless of the mutagenesis technique used.

In the judgment, it has been decided primarily to review recital 17 in combination with Annex IB of the Directive 2001/18 / EG, which deals with genetic modification methods excluded from regulation where mutagenesis is stated as a method which is exempted (see the fact box below).

Thus we interpret recital 17 in the way, that when the directive was written, it was found that methods that could be defined as genetic modification have already been in place for a long time, such as mutagenesis, and the results did not prove to cause safety problems. Consequently, it is considered that an increased genetic variation in the form of mutations within the framework of the genome of a plant species has not been shown to present an increased risk to health and the environment.

It seems as if, for the outcome of the judgment, neither has one sought scientific expertise to inform themselves nor consulted the authorities of the member states that already made a statement and on what grounds they made their standpoint. In repeated cases, the judgment mentions the possibility of developing herbicide-resistant crops with the new targeted mutagenesis methods, thus equating the methods with transgenic methods to insert new DNA into the genome. "This reasoning is strange and clearly shows the shortcomings of the judgment and is not based on scientific facts," the researchers mean. Precision mutation for herbicide tolerance cannot be a reason to equate with transgene, since herbicide tolerant plant varieties obtained with traditional plant breeding and other mutagenesis methods have been cultivated. The debate surrounding herbicide tolerance derives from the fact that spontaneous mutations for herbicide tolerance in weeds can proliferate extensive use of herbicides in cultivation landscapes. The spreading of herbicide tolerance is thus a cultivation system problem and not a breeding technology issue. If you have problems with chemicals and herbicides, it would be logically reasonable to regulate the chemical or herbicide.

"It's unfortunate that the whole question has centered around a single trait and let that influence the judgment to such an extent; a fraction of what's going on in research and of the traits on the way to the market that can contribute to productive and sustainable agriculture, " the researchers say. An example that is mentioned is a genomic wheat that has become fungal resistant by mutation and which then can be cultivated with considerably less inputs and, as the rest of the world will surely have access to soon, but where we in Europe must continue to grow varieties that need to be sprayed.

Sweden's starch producers, in collaboration with SLU researchers, have used targeted mutagenesis to produce a potato whose starch has clear quality and environmental benefits. "With the new potato, we can reduce the use of chemicals in our production drastically," says Mathias Samuelsson, Research director at the Swedish Starch Manufacturers Association. Working towards a more sustainable production is something that the company sees as extremely important. The starch can be classified as a "green label" product and has improved quality properties for both food and technical products. Moreover the production will be significantly more resource-intensive completely in line with the sustainability goals in Agenda 2030. Since the same mutation can be found in commercially grown maize varieties, originating in spontaneous mutation, and in a commercially grown potato refined with other mutagenesis, we consider the property as proved safe for both health and the environment. The mutations in the new potato cannot be distinguished from other mutations, they might as well be spontaneous and random. No new DNA has been inserted, why the potato cannot be defined as transgenic. One of the benefits of controlling mutations is that we can add one or a few properties to modern, existing resource-efficient (high-yielding) potato varieties.

Facts

A fundamental prerequisite for all plant breeding is genetic variation. If there is no genetic variation, it will not be possible to develop new and better plant varieties, as all are identical. A tool that has been used for a very long time is to identify or induce mutations to obtain genetic variation in agronomically important genes. Mutagenesis has been used as a breeding method for over 70 years and more than 3000 varieties have mutagenesis in their lineage and make up a significant part of what we grow and consume today. Without mutagenesis as a refining tool, we would today face even greater global challenges having lower crop yields and cultivated crops with lower nutritional content and less resistance, just to name a few examples.

During the 1980s, new techniques were developed enabling production of recombinant new genes and transmission of genes between species, called transgenes in the judgment. Then, over 30 years ago, it was seen as important to ensure that new plants produced with transgenesis were sufficiently safe for use in the environment, so the use of these plants was regulated. However, it was found that increasing genetic variation with mutagenesis could be defined as genetic modification, but having been used for a long time without causing safety problems it was excluded from regulation.

Extract from Directive 2001/18 / EC on which the verdict is based.

Recital (17)

This Directive should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record.

ANNEX I B

TECHNIQUES REFERRED TO IN ARTICLE 3

Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are:

(1)mutagenesis,

(2)cell fusion (including protoplast fusion) of plant cells of organisms which can exchange geneticmaterial through

traditional breeding methods.

Per Hofvander, Researcher at Swedish University of Agricultural Sciences (SLU)

Mariette Andersson, Researcher at Swedish University of Agricultural Sciences

Hans Berggren, CEO Swedish Starch Manufacturers’ Association (SSF)

Mathias Samuelsson, Research & Development Director, Swedish Starch Manufacturers’ Association

Stina Nilsson, Owners’ Administration Manager, Swedish Starch Manufacturers’ Association

Swedish Starch Manufacturers’ Association (SSF), is owned by 600 farmers in the south east part of Sweden. Every year some 300 000 tons potato is processed into some 80 000 tons potato starch. The company group has their own companies in Sweden, Denmark, Germany, Czech Republic, Latvia, Poland, Russia and China and has an annual turnover of appr. 1800 MSK.

The researchers can be found at The Department of Plant Breeding at The Swedish University of Agricultural Sciences (SLU), world leader when it comes to applications of CRISPR-Cas9 technique as method of refinement of potato.

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Contact details: Per Hofvander: +46 (0)40 415013 per.hofvander@slu.se

Mariette Andersson: +46 (0)40 415541 mariette.andersson@slu.se

Hans Berggren: +46 (0)73 040 42 01 hans.berggren@lyckeby.com

Mathias Samuelsson: +46 (0)73 043 34 72 mathias.samuelson@lyckeby.com

Links:

Press link regarding Japan’s Ministry of Environment (MOE) positive point of view on CRISPR technique.

http://news.agropages.com/News/NewsDetail---27303.htm

Press release from Swedish Starch Manufacturers’ Association and EU judgment.

http://www.lyckeby.com/%C3%B6kad-h%C3%A5llbarhet-med-crispr-cas9

Press release from The Swedish University of Agricultural Sciences about new potato variety

https://www.slu.se/ew-nyheter/2016/10/specialpotatis-for-starkelseindustrin-blir-sveriges-forsta-crispr-cas9-groda/

Press release from EU court:

(https://curia.europa.eu/jcms/upload/docs/application/pdf/2018-07/cp180111en.pdf

Press release from USDA; https://content.govdelivery.com/accounts/USDAOC/bulletins/201b204#.W1t8uNXVEJM.twitter

Publication about genome edited wheat;

Wang et al. Nature Biotechnology 2014 Sep;32(9):947-51. doi: 10.1038/nbt.2969. "Simultaneous editing of three homoeoalleles in hexaploid bread wheat confers heritable resistance to powdery mildew."

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