The GMO lobby is trying to win public acceptance and a regulatory light touch for new GM techniques

The article below (item 1) represents an attempt by GMO lobbyists to normalise new GM "genome editing" techniques and make them appear no different from natural breeding.

The lobbyists frame their argument in the current GMO industry meme that overly restrictive "EU rules" are holding back progress in crop development. It's no coincidence that the TTIP EU-US trade agreement is also focused on dismantling Europe's GMO regulations and bringing them into line with the feeble US system of GMO "deregulation".

Unfortunately attempts to paint "genome editing" techniques as safer, more precise, and more acceptable than GM are just another desperate spin exercise with no grounding in scientific evidence or even sound scientific theory, as the excerpt below (item 2) from GMO Myths and Truths explains.

The excerpt discusses the new "genome edited" version of canola mentioned in the Guardian article, pointing out that it's still a GMO and doesn't deserve any lighter regulation than any other GMO.

Natalie Bennett of the UK Green Party is correct when she says: “With new techniques and possibilities being developed every year, now is not the time to allow a wild west of release of organisms without full safety oversight and consumer information.”

The Science Media Centre's hand is visible in this lobbying effort to have "genome edited" products regulated lightly or not at all:

The Independent also ran an article on the topic, but with precisely no critical comments.

1. Genome editing of crops may be restricted by EU rules, warn scientists
2. Is GM technology becoming more precise?

1. Genome editing of crops may be restricted by EU rules, warn scientists

Fiona Harvey
The Guardian, 21 July 2014

* New technology designed to fight disease and improve yield, but different from GM, speeds up natural process of gene adaptation

A fledgling technology to manipulate the genes of crops in order to make them less susceptible to disease and more productive is at risk of falling foul of the European Union’s genetic modification rules, scientists warned on Monday.

Genome editing is different to genetic modification, because it does not usually involve transplanting genes from one plant or species to another, but on pinpointing the genetic mutations that would occur naturally through selective breeding. This means that, in most cases, it mimics natural actions and does not require the wholesale transformation of genes with which GM is often associated.

Genome editing typically involves finding the part of a plant genome that could be changed to render it less vulnerable to disease, or resistant to certain herbicides, or increase yields or other desirable traits. Researchers use “molecular scissors” to break apart the genome and repair it, which is a process that occurs naturally when plants are under attack from diseases and can throw up new mutations that enable the plant to survive future attacks. This evolutionary process can effectively be speeded up now that it is possible to examine plant genomes in detail in laboratories, and create mechanisms through which the relevant genes can be altered very precisely, without the need to import DNA from other organisms, one of the key criticisms of GM foods.

“Using these methods to introduce new variations, our ability to create new genes is nearly limitless,” said Sophien Kamoun, of the Sainsbury Laboratory at the John Innes Research Centre in Norwich. “We can be much more precise [than with conventional plant breeding].”

As the processes mimic those of nature, but speeded up, the end result is the same as if the sort of selection routinely practised by farmers for centuries had been used, scientists said. Huw Jones, of Rothamsted Research, said: “These plants are indistinguishable from those that would occur through selective breeding.” Ottoline Leyser, director of the Sainsbury Laboratory at the University of Cambridge, said gene editing could offer an alternative to GM that could be much more palatable to consumers.

But green campaigners are far from convinced. The European parliament’s Green party told the Guardian: “While the biotech sector has sought to trumpet the benefits and precision of gene editing, compared to existing GM technology, there are many uncertainties as regards the impact of gene-edited organisms on the environment and health.”

The technology is very new, as the first commercial application of it in a plant for human consumption was approved this spring, when the US-based Cibus announced an edited version of canola. Scientists believe there is huge potential for the technology because it avoids the slower, scattergun approach of selective breeding.

It has only become possible to edit plant genes in the past few years following decades of work on mapping genomes and inventing ways in which they can be precisely altered.

Under EU laws, however, it is unclear whether gene editing should be treated in the same way as genetic modification. GM crops are effectively banned in Europe, and licences to experiment in GM are rare and very expensive. In some other parts of the world, most importantly the US, the regulations are much lighter and GM food faces few barriers to animal and human consumption.

The European commission is expected to offer guidance on the technology soon, perhaps next year, but it is not clear whether that could involve a ruling on whether and how the current regulations should apply, or a commitment to further study with the possibility of new regulations. The commission did not respond to requests from the Guardian for comment.

Jones said the lack of clarity on the legal status of gene editing techniques was hampering research and potential investment, particularly in Europe. “Clearly lawyers need to look at it,” he said.

Leyser said the EU should base its regulations on the properties of crops that have been altered or selectively bred, rather than focusing on the process by which this is achieved, as happens at present. “There is no way legislation based on processes is going to keep up with new ways of doing things,” she warned. Assessments of crops that have been modified should be sufficient to avoid harm, rather than arguing over whether genome editing should be treated as GM, she said.

The scientists said the promise of the new technologies, in improving crops and helping to feed the world’s growing population, should not be underestimated.

The Green party/European Free Alliance group in the European parliament said: “Gene editing raises similar concerns as [genetic modification] as regards intellectual property rights and the impact on traditional and organic farming models. As such, it would make sense for gene editing to be covered by the same regulatory regime as existing GMOs. However, the current EU legislation on GMOs is clearly in need of a major overhaul, notably to significantly improve the risk assessment process and ensure its independence, as well as to take account of the socio-economic impact of GMOs.”

Natalie Bennett, the UK’s Green party leader, said: “The Green party believes that with these new technologies, with their often unknown side effects and impacts, it is important to maintain the precautionary principle. These are genetic modifications using new techniques; they should be treated accordingly.

“It was only last week that researchers writing in the prestigious journal Science expressed grave concerns about one particular use of gene editing technology, the gene drive, while the European Food Safety Authority concluded in 2012 that cisgenesis [another technology for altering plants] should be treated in terms of regulation and oversight as a GM technology, at least initially.

“With new techniques and possibilities being developed every year, now is not the time to allow a wild west of release of organisms without full safety oversight and consumer information.”

2. Is GM technology becoming more precise?

John Fagan, Michael Antoniou, and Claire Robinson
GMO Myths and Truths, May 2014
[References at the link above]

Technologies have been developed that are intended to target GM gene insertion to a predetermined site within the plant’s DNA in an effort to obtain a more predictable outcome and avoid the complications that can arise from random insertional mutagenesis.

Some of these technologies use nucleases or “genome scissors” which allow the cutting of DNA and the insertion of new DNA in any position in the chromosomes. The most popular of these new genome scissors are TALENs (transcription activator-like effector nucleases), ZFNs (zinc finger nucleases), and most recently CRISPR-Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats).

These genome scissors are a combination of a unit to recognize specific regions of the DNA and an enzyme to cut both strands of the DNA at a sequence determined by the genetic engineer. When the cell senses that this double-strand DNA break has occurred, it stimulates the cell’s machinery to repair it.

There are two possible outcomes. First, simply allowing the repair to proceed where the cut ends of the DNA are joined back together again (a process known as “non-homologous end-joining”) introduces a mutation at the site of cutting by the genome scissors. This is because non-homologous end-joining repair is not perfect, and in the majority of cases, base units of DNA are lost from the ends of the DNA during the joining process.

Second, at the same time that the genome scissor gene is introduced into the plant cell, the genetic engineer can also introduce a separate DNA molecule that has the same regions in it as the region that he is trying to modify in the host genome, but which also contains a gene coding for the desired additional trait. The artificial gene that has been introduced can align with the corresponding region of the host cell’s DNA. In some instances the cell uses this second introduced DNA molecule as a guide to repair the double-stand DNA break in a process known as “homologous recombination”. The final result is the repair of the double-strand DNA break, but with the incorporation of the artificial gene at this pre-determined site.

By using these methods, genes can be knocked-out (silenced) or mutated, or new DNA including whole gene units can be inserted.

Proponents claim that these technologies offer “targeted genome editing”. However, these GM transformation methods are not failsafe. Two studies found that ZFNs caused unintended genomic modifications in off-target sites in human cell lines. The simple word for “modifications in off-target sites” is “mutations”. That is, these techniques can cause unintended mutations in other locations in the genome, causing a range of potentially harmful side-effects. In another investigation using human cells, CRISPR was found to cause unintended mutations in many regions of the genome.

Biotechnologists still know only a fraction of what there is to be known about the genome of any species and about the genetic, biochemical, and cellular functioning of our crop species. That means that even if they select an insertion site that they think will be safe, insertion of a gene at that site could cause a range of unintended effects, such as disturbances in gene expression or in the function of the protein(s) encoded by that gene.

Even if there is no disturbance at the level of the gene, there may be disturbance at the level of the protein for which the gene encodes. For example, a plant may have an enzyme that is normally inhibited by a herbicide, meaning that the plant will die if that herbicide is applied. If the plant is genetically modified to alter the enzyme so that it is not inhibited by the herbicide (genetic engineered for herbicide tolerance), there may be knock-on effects. Enzymes are not totally specific. If the activity of the enzyme is changed, the plant’s biochemistry could be altered in the process, causing unknown chemical reactions with unknown consequences.

Moreover, because tissue culture must still be carried out for these new targeted insertion methods, the mutagenic effects of the tissue culture process remain a major source of unintended damaging side-effects.

Effects could include:

* Unexpected toxins or allergens, or an alteration in nutritional value
* Reduced ability of the GM crop to resist disease, pests, drought, or other stresses
* Reduced productivity or vigour
* Unexpected environmental effects, such as increased weediness.

According to a German newspaper, plants produced using these technologies are already being grown in greenhouses. The independent research institute Testbiotech says it is not known whether any of the plants have been released into the environment, adding, “There is, however, a clear lack of regulation to ensure that these plants, which are genetically modified organisms, undergo risk assessment.”

Rapid Trait Development System: GM or not?

The biotechnology companies BASF and Cibus have developed oilseed rape and canola with a technique called RTDS (Rapid Trait Development System). According to Cibus, RTDS is a method of altering a targeted gene by utilizing the cell’s own gene repair system to specifically modify the gene sequence in situ, and does not involve inserting foreign genes or gene expression control sequences. The Gene Repair Oligonucleotide (GRON) that effects this change is a chemically synthesized oligonucleotide, a short, single-stranded DNA and/or RNA molecule.

Cibus markets its RTDS crops as non-transgenic and as produced “without the insertion of foreign DNA into plants”. The company adds that crops developed using this method are “quicker to market with less regulatory expense”. Cibus says that the RTDS method is “all natural”, has “none of the health and environmental risks associated with transgenic breeding”, and “yields predictable outcomes in plants”.

However, GM is a process, and the definition of genetic modification does not depend on the origin of the inserted genetic material. Crops created with RTDS can and should be described as GMOs, since RTDS alters the genome in a manner that would not occur naturally through breeding or genetic recombination. The fact that no foreign DNA is inserted into the recipient plant’s genome is immaterial.

In addition, RTDS still involves tissue culture, which introduces genome-wide mutations. Some or all of these mutations (the latter in vegetatively propagated plants, e.g. potatoes) will be present in the final marketed product. Also, there will inevitably be off-target effects from the RTDS process. The intent of the RTDS process is specific targeting, but this technique is new and the research has not been done to assess the frequency and extent of off-target effects. The old saying, “Absence of evidence of harm is not evidence of the absence of harm,” is pertinent here.

To assess the fidelity and efficacy of the RTDS process and the extent to which unintended alterations take place at other locations in the genome during RTDS, many different studies will be needed. For instance, one important class of studies that must be carried out is whole genome sequencing of RTDS GMOs. Structural and functional analysis of the proteins present in RTDS GMOs (proteomics), as well as analysis of metabolites present (metabolomics) would also be required. In parallel, the functional performance of these RTDS GMOs should be assessed. The agronomic performance, the impact on the environment, and the quality and safety of the food derived from these RTDS-derived GMOs all need to be investigated, including via long-term toxicological feeding studies.

Even changing a single gene, whether it encodes an enzyme, a structural protein, a peptide hormone, or a regulatory protein, can cause unintended functional or structural disturbances at the level of the cell and the organism as a whole.

RTDS is a genetic modification process, albeit more targeted than other recombinant DNA techniques. Any crops or other organisms produced in this way must be treated in exactly the same way as crops altered using old-fashioned recombinant DNA techniques, namely thorough evaluation of functionality, utility, and safety.

“New” does not necessarily mean “better” or “safer”. RTDS and the other methods described above are new and they were designed to be more specific. This is a laudable intention, but empirical evidence needs to be gathered on the safety and efficacy of these new techniques.

It is interesting to note that the biotech company Cibus, in its publicity materials for the RTDS method, acknowledges the imprecision of standard genetic modification using recombinant DNA techniques.