We have long been aware of genetically modified crops and the divisiveness that the term generates within the EU in particular. We may never know the true opinions of EU consumers on this issue as the debate is driven by a small number of vested interests. While there was rightly concern at the start as to the food safety and environmental aspects of what was a novel practice over three decades ago, it can hardly be right that the same level of restriction is required today.

Last week the Environmental Protection Agency (EPA) held a lecture in UCD entitled The EU Definition of GMOs and New Breeding Techniques. Many new and very precise breeding technologies have been developed since the first transgenic plants but because these manipulate genes they are bound by the same GMO regulations as the techniques that insert foreign genes. The EU is updating its GMO regulations to reflect the new technologies available in plant breeding and these are being referred to as new plant breeding techniques and abbreviated to NBTs for short.

Opening the meeting professor Jimmy Burke of UCD said plant breeding has been at the forefront of crop improvement for hundreds of years and there are now very few species that have not been significantly altered through this improvement process. Plant breeding has brought about many changes based on the stated needs of growers and users and this must continue to evolve as needs change.

Prof Burke said the NBTs are very important tools for breeders as they speed up the development of new varieties and enable precise focus on individual characteristics to help feed the increasing global population. NBTs involve changing DNA sequences at targeted locations using very precise tools such as CRISPR–Cas9. These tools enable breeders to introduce one or a few changes.

How plants or other organisms developed using NBTs are regulated at EU level will have huge ramifications for EU businesses.

21st century technology

Dr Tom McLoughlin from the EPA said modern biotechnology is considered a key technology of the 21st century and the EU has adopted it as an integral part of the EU economy for job creation and sustainable development. He said GMO technology has a history of safe use in the laboratory for the past 40 years and has provided enormous benefits for science and society. It is heavily used in the medical world with uses such as the production of insulin for diabetes, vaccines against viruses like Hepatitis B and medicines for the treatment of rheumatoid arthritis.

While these GMO uses have been widely accepted by the public, agricultural applications of GM crops remain highly controversial and very politicised in the EU. But elsewhere the global acreage of biotech crops has increased 100-fold between 1996 and 2015, making it one of the fastest adopted crop technologies in recent times. Last year, 18 million farmers planted 180 million hectares of GM crops in 28 countries, mainly soya bean and maize.

In efforts to address the concerns relating to GM crops in the EU, Dr McLoughlin said the Commission has spent over €300m researching GMO safety over the past 25 years. And this independent research concluded that GMO crops are no more risky than conventional plant breeding technologies.

The GMO rules

The guest speaker at the event was Professor Piet van der Meer, an expert in the field of GMO regulatory controls. He gave an excellent overview on the history and evolution of GMO regulations in different parts of the world and explained the challenges in the early years. He described how good regulation should work and suggested that a number of the new breeding techniques (NBTs) should be exempt from the GMO legislation under which they are currently controlled.

From a regulator’s perspective, Piet explained the difficulty in initially agreeing definitions and regulations in the 1980s and before. Different countries put in place different rules that are operated in different ways. The initial conundrum asked what should be regulated – the technique, the end product or both? Our rules now regulate and control both elements of novel organism production and, as a consequence, this is forcing a level of control on some technologies many believe to be unjustified.

Many will be aware there are particular problems with the EU regulatory system for GMOs. However, Piet said the EU regulations are actually quite good and that it is their implementation that is causing the problems. Member states, through their governments, can influence these decisions but many are acting to frustrate this process by abstaining in votes during the decision-making process. This is proving to be frustrating for all involved.

This has been the story of GMO crops to date. And while the technology used to produce many of these transgenic crops was novel three to four decades ago, many aspects of recombinant DNA technology are now well accepted and known to be as safe as conventional breeding. Regulations should be able to take this into account by either modifying its requirements during the licensing process or by exempting some of the processes used in the creation of these crops from the GMO legislation.

The problem in the EU is that this has not happened, Piet said. Because our regulations and definitions focus around “novel” practices and products this needs to be a fluid process to evolve with the knowledge gained. He said novel concepts cannot be assumed to be unsafe but where we do not know this it is reasonable to demand that the facts be established.

The NBTs

We currently view GM crops as those mainly originating from the transfer of a gene from another species, which were mainly used to confer either herbicide tolerance or insect resistance. However, this is old technology and there are now many new tools in the biotechnology toolbox for plant breeders. Regulation must reflect these developments.

These technologies are much more precise than the original gene transfer methods and many can be used to alter the physical characteristics of a plant without adding anything in or taking anything away. Many such tools are capable of genome editing by altering, in one way or another, the existing genetic material.

These new breeding techniques, NBTs for short, are relatively new, novel and extremely precise tools capable of targeted editing or altering of the genome. Genes can be switched on or off using various techniques which can provide useful growing or quality characteristics without altering the plant’s genetic make-up.

Other techniques

Other breeding techniques can also be used to help alter the expression of the existing genetic make-up of the genome, such as grafting of rootstock, reverse breeding, agro-infiltration and RNA-directed DNA methylation. Also cisgenesis or intragenesis – the movement of genes between the same plant type.

All of these techniques can, in different ways, speed up the targeted delivery of new varieties from plant breeding. Conventional breeding requires the mixing of gene pools in the hope of combining useful existing characteristics with one or two additional ones. It may be successful but many of the progeny are likely to have other undesirable characteristics which then take time to breed out. NBTs can guarantee a more precise outcome in a fraction of the time.

NBTs are currently bound by existing GMO regulations and this virtually prohibits their commercial use in the EU as these regulations add massively to the cost of a new variety.

The EU has been attempting to reform the regulations that apply to these techniques. Some of these technologies could be exempted from existing GMO regulations. This has been a very slow process and a report on same is being promised every year.

Professor van der Meer is of the view that a modified plant which is not “novel” should not be subject to GMO legislation. However, he emphasised that it must be the product that is exempted and not the technique, because most techniques can be used in different ways to produce very different end results.

“New or novel isn’t necessarily dangerous; it’s just that we have limited experience of it,” he said.

New varieties from conventional plant breeding are not regarded as novel and the end result of many of these new breeding technologies are not novel either, Piet stated.

A number of EU countries have already indicated that they view some of these specific technologies as not being GMOs.

Interview: Piet van der Meer

Piet van der Meer trained as a biologist and a lawyer at the University of Leiden in the Netherlands and specialised in microbiology and ecology, as well as in environmental and international law. He held various posts within the Dutch regulatory system and was closely involved in the development of the EU Directives on GMOs. He went on to provide training on biosafety regulations and risk assessment for pre-accession countries in Central and Eastern Europe. He is now an independent consultant in the fields of international and national environmental policies and regulations, with a particular specialisation in biotechnology regulation.

Discussion

During discussion the question was asked if the EU institutions were excessively genophobic? The comment was made that there has been a significant drive to impose continued restrictions of genes modified through genome manipulation while invasive plants are ignored and allowed to thrive in our ecosystem in Ireland. These are having a much more devastating impact on natural environments.

A number of those present reiterated the need for the EU to give clarity on how NBTs will be regulated. They just wanted a decision either way as the ongoing state of limbo is extremely damaging. Research capability continues to leave the EU because of the absence of a clear direction.

Listen to an interview with Piet van der Meer in our podcast below:

Responding to a good question with regard to the unintended consequences of GMOs, Piet commented that GM crops carry no more inherent risk than conventional breeding. He commented that the development of herbicide resistance is not a consequence of GM but rather a consequence of misuse of herbicide. This can happen to any herbicide and we already have many such incidences in Ireland. “Resistance risk belongs to the herbicide rather than the genetics”, Piet stated.

Asked about labelling, Piet said that he would favour labelling which states something. A label that states that an ingredient come from a genetically modified product says nothing. To be useful a label needs to state what the modification did and if it may pose any additional risks to a sector of society such as a new allergy or the transfer of a gene known to be associated with an allergy in another species.