Gene-edited organisms fall within the definition of GMOs in European and international law. They also present real risks to the environment and human health – and must be regulated like any other GMOs

At last, here is a beautifully clear article written by scientists for the layperson on this vital issue.
—

GM 2.0? 'Gene-editing' produces GMOs that must be regulated as GMOs

Janet Cotter & Ricarda Steinbrecher
The Ecologist, 13 Jan 2016
http://www.theecologist.org/News/news_analysis/2986839/gm_20_geneediting_produces_gmos_that_must_be_regulated_as_gmos.html
[links to sources at the URL above]

* The EU is considering the exclusion of gene-edited plants and animals from GM regulations, write Janet Cotter and Ricarda Steinbrecher. However gene-edited organisms clearly fall within the definition of GMOs in both European and international law. They also present real risks to the environment and human health - and must be regulated like any other GMOs.

There has been a lot in the news recently about the ethics of gene editing in humans.

But, as yet largely unnoticed is that the European Commission is considering whether the gene-editing of plants and animals, for example in agriculture, falls outside the scope of EU regulations governing genetically modified organisms (GMOs).

In other words, whether the products of gene-editing should be labelled and regulated as GMOs, or allowed to enter the food chain untested and unlabelled.

If you believe the proponents' claims, gene-editing is nothing more than the "tweaking" of DNA in plants and animals - nothing to be concerned about.

But the reality is that gene editing is simply GM 2.0, with many of the same concerns and problems as the GM crops that Europeans have already rejected.

What is gene-editing?

Gene-editing is a form of genetic engineering. It covers a range of new laboratory techniques that, just as older genetic engineering techniques, can change the genetic material (usually DNA) of a living organism, for example a plant or an animal, without breeding.

In many respects, they are similar to the 'traditional' genetic engineering we are familiar with. The difference is that these techniques can change the DNA of the plant or animal at a specific 'targeted' location, compared to the insertion of genes at random locations characteristic of previous techniques.

Many of these techniques can be used to insert genes from an unrelated species into a plant or animal as traditional genetic engineering does and the resulting products, with their novel genes would be regarded as GMOs. But not all the applications of gene-editing involve the insertion of novel genes.

The current debate surrounds applications of gene-editing that, instead of inserting genes, re-write genes using a sort of "DNA typewriter". The question is whether plants and animals with 'edited' genes (without inserted novel genes) should be regulated as GMOs.

Products of gene editing with re-written genes that might be imported, grown or farmed in Europe in the near future, including the UK, include a herbicide-tolerant oil seed rape, produced by a technique known as oligonucleotide directed mutagenesis (ODM), and hornless cattle, developed through a technique known as "CRISPR".

CRISPR is becoming well known in scientific circles as it's a particularly efficient method of gene-editing.

The risks of gene-editing?

With current commercial GM crops, one of the major concerns is that unexpected effects can result, and have resulted, from the genetic engineering process, and these can affect food and environmental safety. These effects can include, altered levels of toxins or nutritional compounds and changes to the protein chemistry, which could produce new allergens.

That is why the EU has set up regulations for GM organisms, requiring them to undergo an environmental and health risk assessment before they are grown or reared commercially or enter the food chain. Even so, doubts linger as to the effectiveness of these assessments.

"Traditional" genetic engineering involves the random insertion of genes (or genetic sequences) into an organism's genome. Proponents tell us that gene-editing is far more precise than the genetic engineering techniques we are familiar with. But what exactly is meant by "precise" here?

Gene-editing techniques may perhaps be more precise at the level and point where the DNA is altered but how this altered DNA might affect interactions with other genes and processes within the cell is largely unknown. Importantly, these gene-to-gene interactions within the cell are reflected in the organism as a whole.

The effects of the altered DNA on the wholesomeness as a foodstuff and how the organism interacts with the environment are far from being precisely known. Therefore, although gene-editing may be more precise in the intended location where the DNA is modified, there is still potential for unexpected and unpredictable effects.

Such effects could have implications for food, feed and environmental safety if they increase levels of toxic compounds, reduce levels of nutritional compounds or even produce new allergens.

"Off-target" genetic alterations

Just like traditional genetic engineering, gene-editing techniques can cause unintended alterations in the DNA. For example, several gene-editing techniques use so-called "molecular scissors" to cut DNA as part of the editing process.

These molecular scissors sometimes have what is known as "off-target" effects. This means the DNA is cut in unintended places as well as the intended places, accidentally causing additional genetic alterations.

Other gene editing techniques such as ODM could also edit DNA in the wrong place. In addition, the newly edited gene could interact with other genes in different ways, affecting protein composition and production, chemistry and metabolism.

Many of the gene-editing techniques are so new that it is not yet possible to fully evaluate the potential for and consequences of unintended changes. Importantly, just because gene-edited organisms don't contain foreign DNA, this doesn't make them safe.

Furthermore, there is increasing evidence of 'off-target' effects. The intended change (e.g. tolerance to a herbicide or cattle without horns) may be clear to see, but the unintended changes aren't immediately apparent, and certainly not apparent if they aren't looked for. It's a case of "don't look, won't find".

The law is clear: gene-editing is still genetic engineering

The question being debated in the EU at the moment is whether small "edits", i.e. changes, insertions or deletions, of segments of DNA without the insertion of new genes are also to be considered as producing a GMO, or fall outside the scope of European law.

At the core of this debate is the question of what is the distinction between conventional breeding that involves mating and GMOs. In both the EU law (Directive 2001/18) (See Article 2(2) and Annexes, below) and the UN agreement on GMOs – the Cartagena Protocol, made under the Convention on Biological Diversity – GMOs involve novel arrangements of genetic material that do not occur naturally, and alterations to genetic material being made directly without mating.

The Directive contains annexes which define exactly what techniques of genetic alteration do, and do not, fall under the definition (reproduced in full below). However gene-editing simply is not mentioned: the technology did not exist in 2001 when the law was written. That means we have to rely on the initial definition:

"'Genetically modified organism (GMO)' means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination."

Likewise, the Cartagena Protocol, adopted in 2000, does not specifically list gene-editing as a technology included in its definition (full version below). However the technology, once again, is encompassed by the simple meaning of the words:

"'Living modified organism' means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology; ... 'Modern biotechnology' means the application of: a. In vitro nucleic acid techniques, including ... "

In terms of the Directive, it is accurate to say that in gene-edited organisms "the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination".

In terms of the Cartagena Protocol, in is accurate to say that a gene-edited organism "possesses a novel combination of genetic material obtained through the ... application of ... In vitro nucleic acid techniques".

So in fact - despite the abstruse legal arguments deployed by GM advocates - the law is perfectly clear on the issue. According to the both the EU and Cartagena definitions, gene-editing produces GMOs.

Therefore to remove or exempt gene-editing from regulation, as GM advocates wish, the EU would need to amend the existing Directive. If it tried to interpret the Directive as GM advocates wish, the decision would surely by challenged in the European Court, for example by one of the many EU countries opposed to the use of GMOs in farming - where in our opinion it should struck down.

Does it matter if gene-editing is not classed as a GM technique?

If crops and animals developed by gene-editing techniques are officially considered non-GM, or exempted from the EU GMO laws, then they will enter the food chain and the environment completely unregulated and unlabelled.

This means there would be no assessment of food or environmental safety; no requirement to detect any unintended alterations to the organisms' DNA or its consequences and no assessment of the implications of the trait produced by gene editing (e.g. herbicide tolerance).

Gene-edited foodstuffs would not have to be labelled. European consumers have resoundingly said "No!" to GM crops, yet there would be no way for consumers and farmers to avoid gene-edited crops and animals if they were not classified (and hence labelled) as GMOs.

Importantly, although gene-editing might be promoted as causing only small changes in DNA, it can be used repeatedly to achieve substantial changes to one or even several genes. This raises the concern that the alterations could involve the introduction of, for example, whole new chemical pathways within a plant or animal with a high potential for unexpected effects.

Such organisms would end up in our environment and on our dinner plates completely unregulated if gene-editing techniques are not encompassed by the GMO regulations.

The EU's GMO laws were devised to protect against the risk of organisms developed by the direct alteration of genetic material using modern biotechnologies (e.g. by in vitro techniques) entering the environment and food chain.

It's clear that gene-edited crops and animals need to be assessed as GMOs in the same ways as current GM crops. Otherwise EU citizens will unwittingly be exposed to the risks of genetic engineering without testing or labelling, as will the environment, biodiversity and agriculture.

Dr Janet Cotter runs an environmental consultancy, Logos Environmental. She was previously Senior Scientist with Greenpeace International for 15 years.

Dr Ricarda Steinbrecher is a biologist, geneticist and co-director of EcoNexus. She has worked on GMOs since 1995, especially UN-led processes on Biosafety, the risk assessment of genetically engineered organisms and synthetic biology. She's a founding member of the European Network of Scientists for Social and Environmental Responsibility and works with civil society and small-scale farmer groups world-wide.

Additional reporting by The Ecologist.

Additional notes available here:
http://www.theecologist.org/News/news_analysis/2986839/gm_20_geneediting_produces_gmos_that_must_be_regulated_as_gmos.html