The world faces enormous challenges in producing sustainable food for its growing population, given the escalating pressures of climate change and biodiversity loss.
There can be no doubt that SARS-CoV-2, the causative agent for COVID-19, reminded us of our vulnerability and the need to be better prepared for potential future pandemics. The same can be said of how we produce our food and the potential for food shortages due to drought, floods, forest fires and the advent of more aggressive plant/animal diseases/pests.
The EU’s Farm to Fork strategy is the cornerstone of its Green Deal. Its objective is to contribute to a more sustainable food production system by reducing dependency (among other things) on pesticides and antimicrobials by 50%. The strategy refers to new innovative techniques, including biotechnology and the development of bio-based products, which may play a role in increasing sustainability.
New gene editing (GE) techniques
Over the past 70 years, mutations in plant genomes have been induced by plant breeders using ionising radiation (UV, x-rays, gamma rays) or chemicals (ethyl methane sulfonate-EMS) to increase genetic variability. This practice is called random mutagenesis and the resulting organisms are technically genetically modified organisms (GMOs). Those GMOs are explicitly exempt from the scope of EU GMO legislation on the basis that they have a long history of safe use. Much of the food we eat today originated from this technology.
The most recent addition to the breeder’s toolbox (discovered in 2012) is a (GE) technique called CRISPR-Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats).
The advantage of GE over traditional breeding is that the changes it makes are more targeted
Described as a genetic scissors, it can be used by scientists to change the DNA of animals, plants, and microorganisms with extremely high precision.
The advantage of GE over traditional breeding is that the changes it makes are more targeted. With GE techniques such as CRISPR, it is possible to mutate only a tiny part of the genome. This can be done without adding foreign DNA and genes can be edited that already exist in the plant. This GE technique speeds up breeding and accelerates the selection of plants with desirable traits such as higher yields, higher pest resistance, improved nitrogen and phosphorous utilisation, and a range of quality characteristics.
There are already several GE crops entering the world market – mildew resistance in wheat, soya beans with increased oleic acid levels, drought-tolerant maize, high-fibre wheat, reduced gluten content in wheat etc.
In a safety assessment in 2020, the European Food Safety Authority concluded that GE techniques that modify the DNA of plants do not pose more hazards than conventional breeding or techniques of genetic modification.
GE tools also enable scientists to offer solutions to a range of public health challenges.
ECJ ruling on mutagenesis
In 2018, the European Court of Justice (ECJ) ruled that organisms obtained by induced or ‘classical’ random mutagenesis constitute GMOs and that these are exempt under the GMO Directive. However, the ruling also stated that organisms obtained through techniques of directed mutagenesis (eg mutagenesis involving techniques like CRISPR) are not excluded from the scope of the directive.
The ruling prompted many European plant and life science scientists to submit a paper to the European Commission outlining the negative consequences for agriculture
Since that ruling, which means that all GE organisms are GMOs under EU law, there has been much debate about its implications. Industry, breeders, farmers, and academia were alarmed at the court’s decision, while some NGOs welcomed it.
The ruling prompted many European plant and life science scientists to submit a paper to the European Commission outlining the negative consequences for agriculture if all organisms developed with GE will have to comply with EU rules on GMOs. This prompted the European Council in November 2019 to request the Commission to submit “a study in light of the ECJ ruling regarding the status of new genomic or gene editing techniques under union law”.
The EU study
This study is to deal with, among other things, the status and use of GE techniques in plants, animals and microorganisms for agri-food, industrial and pharmaceutical applications. GE techniques are defined as techniques capable of changing the genetic material of an organism and that have emerged or have been developed since 2001, when the existing GMO legislation was adopted.
Member states requested this study as the EU’s GMO legislation was not implementable in its current form. Therefore, it is essential that it be updated to reflect the current state of science and technology. New technologies are emerging all the time that could be important tools to help the EU achieve its Farm to Fork and biodiversity strategy objectives.
Contributing towards this process, 12 legal and scientific experts in the EU (including myself) published an article in January 2021 titled: “The Status under EU Law of Organisms Developed through Novel Genomic Techniques”. That article concludes that the 2018 ECJ ruling merely “sheds light on the court’s general thinking” but did not address the legal status of organisms developed through GE techniques in general (nor was it asked to do so).
But is the EU’s GMO regulatory system fit for purpose?
1 The EU regulatory framework regarding genetically modified organisms (GMOs) was established in 1990. While the legislation has been revised, the definition of GMOs has remained unchanged for over 30 years.
2 Unlike plants produced as GMOs, plants and products derived from GE are not easily detectable (no foreign DNA is introduced) and would give EU member states ‘an impossible’ traceability task, especially in terms of unknown GE plant products. This would make EU legislation on labelling and traceability unworkable. If GE techniques remain under the same controls as GMOs, they are unlikely to be widely used in the EU. The EU has already spent €300m on safety studies over a 25-year period, which concluded that GMO is not per-se riskier than conventional plant breeding technologies.
3 If the current situation pertains, it is likely that the brain drain will continue from the EU as our brightest students relocate to countries where GE can contribute to new innovations. The continued blocking of access to this technology could threaten the competitiveness of farming in the Farm to Fork era.
Further information around the EU study can be found here.
GE in other countries
Countries like Argentina, Australia, Brazil, the US and Japan have concluded that organisms developed with certain GE applications will not be regulated as GMOs. The UK government is of the view that GE should not be regulated as GMOs if the organisms produced could have been produced by traditional breeding methods. It is currently carrying out a public consultation on GE.
Are EU attitudes changing?
There is certainly an increasing interest in GE and GM technology. This could be driven by the part it played in the identification of the three vaccines now used for the Sars-Cov-2 virus pandemic. The AstraZeneca vaccine is labelled ‘recombinant’. In July 2020, the EU suspended (temporary derogation) some of its GMO regulations to fast-track the development of the coronavirus vaccines.
This was seen as hypocritical, as some of these vaccines use the same GM techniques that had been vigorously opposed for GMO crops by many EU member states, NGOs and politicians over the past 30 years.
Need to review the EU GMO system
One of the main issues with the current system is that decision-making has become highly politicised at EU level. This could continue to effectively prohibit the use of GE techniques in the EU and Ireland.
If this happens, the EU could lose these new GE tools for agriculture, sustainability, biodiversity and for biomedicine/public health purposes.
Member states must be aware of the role that GE/GMO technology is playing in the development of GM-derived COVID-19 vaccines. Therefore, EU member states should review the regulatory approval systems for GE technologies, so that all sectors of society – agriculture, environment and medical – can benefit from their potential.
The outcome of this Commission consultation (to be submitted by 30 April 2021) might offer an opportunity to provide clarification on foot of the ECJ judgment
In 2107, the Dutch government proposed that the GMO Directive should not apply to plants resulting from the use of GE techniques like CRISPR, provided these plants are at least equally as safe as plants obtained by traditional breeding. I suggest the Irish Government support this Dutch proposal. This is in line with the decisions taken by other jurisdictions globally, and will ensure legal certainty and the smooth running of global trade in agricultural products. This message needs to be communicated by the Irish Government at EU level and in the European Parliament through our MEPs.
The outcome of this Commission consultation (to be submitted by 30 April 2021) might offer an opportunity to provide clarification on foot of the ECJ judgment to ensure that the uncertainty around the status of organisms developed through GE can be addressed.
We must hope that the intransigence regarding GMO adoption in the EU for the past 30 years does not continue to blight the adoption of gene editing technologies.
If GE techniques like CRISPR are regulated as GMOs in the EU, this will deprive Europe of genetic potential to help fulfil many of its new strategy objectives.Because nothing has been added or taken away from the genetic code, these traits cannot be identified or policed. If the current interpretation of the law is not changed, the EU will continue to experience a brain drain while importing products produced elsewhere with GE technologies because they cannot be identified. * Dr Thomas McLoughlin worked as a research scientist with leading biotechnology companies and universities in microbial ecology/genetics for 20 years. He later worked as a senior scientist for the EPA (now retired) on the implementation of GMO regulations.
The world faces enormous challenges in producing sustainable food for its growing population, given the escalating pressures of climate change and biodiversity loss.
There can be no doubt that SARS-CoV-2, the causative agent for COVID-19, reminded us of our vulnerability and the need to be better prepared for potential future pandemics. The same can be said of how we produce our food and the potential for food shortages due to drought, floods, forest fires and the advent of more aggressive plant/animal diseases/pests.
The EU’s Farm to Fork strategy is the cornerstone of its Green Deal. Its objective is to contribute to a more sustainable food production system by reducing dependency (among other things) on pesticides and antimicrobials by 50%. The strategy refers to new innovative techniques, including biotechnology and the development of bio-based products, which may play a role in increasing sustainability.
New gene editing (GE) techniques
Over the past 70 years, mutations in plant genomes have been induced by plant breeders using ionising radiation (UV, x-rays, gamma rays) or chemicals (ethyl methane sulfonate-EMS) to increase genetic variability. This practice is called random mutagenesis and the resulting organisms are technically genetically modified organisms (GMOs). Those GMOs are explicitly exempt from the scope of EU GMO legislation on the basis that they have a long history of safe use. Much of the food we eat today originated from this technology.
The most recent addition to the breeder’s toolbox (discovered in 2012) is a (GE) technique called CRISPR-Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats).
The advantage of GE over traditional breeding is that the changes it makes are more targeted
Described as a genetic scissors, it can be used by scientists to change the DNA of animals, plants, and microorganisms with extremely high precision.
The advantage of GE over traditional breeding is that the changes it makes are more targeted. With GE techniques such as CRISPR, it is possible to mutate only a tiny part of the genome. This can be done without adding foreign DNA and genes can be edited that already exist in the plant. This GE technique speeds up breeding and accelerates the selection of plants with desirable traits such as higher yields, higher pest resistance, improved nitrogen and phosphorous utilisation, and a range of quality characteristics.
There are already several GE crops entering the world market – mildew resistance in wheat, soya beans with increased oleic acid levels, drought-tolerant maize, high-fibre wheat, reduced gluten content in wheat etc.
In a safety assessment in 2020, the European Food Safety Authority concluded that GE techniques that modify the DNA of plants do not pose more hazards than conventional breeding or techniques of genetic modification.
GE tools also enable scientists to offer solutions to a range of public health challenges.
ECJ ruling on mutagenesis
In 2018, the European Court of Justice (ECJ) ruled that organisms obtained by induced or ‘classical’ random mutagenesis constitute GMOs and that these are exempt under the GMO Directive. However, the ruling also stated that organisms obtained through techniques of directed mutagenesis (eg mutagenesis involving techniques like CRISPR) are not excluded from the scope of the directive.
The ruling prompted many European plant and life science scientists to submit a paper to the European Commission outlining the negative consequences for agriculture
Since that ruling, which means that all GE organisms are GMOs under EU law, there has been much debate about its implications. Industry, breeders, farmers, and academia were alarmed at the court’s decision, while some NGOs welcomed it.
The ruling prompted many European plant and life science scientists to submit a paper to the European Commission outlining the negative consequences for agriculture if all organisms developed with GE will have to comply with EU rules on GMOs. This prompted the European Council in November 2019 to request the Commission to submit “a study in light of the ECJ ruling regarding the status of new genomic or gene editing techniques under union law”.
The EU study
This study is to deal with, among other things, the status and use of GE techniques in plants, animals and microorganisms for agri-food, industrial and pharmaceutical applications. GE techniques are defined as techniques capable of changing the genetic material of an organism and that have emerged or have been developed since 2001, when the existing GMO legislation was adopted.
Member states requested this study as the EU’s GMO legislation was not implementable in its current form. Therefore, it is essential that it be updated to reflect the current state of science and technology. New technologies are emerging all the time that could be important tools to help the EU achieve its Farm to Fork and biodiversity strategy objectives.
Contributing towards this process, 12 legal and scientific experts in the EU (including myself) published an article in January 2021 titled: “The Status under EU Law of Organisms Developed through Novel Genomic Techniques”. That article concludes that the 2018 ECJ ruling merely “sheds light on the court’s general thinking” but did not address the legal status of organisms developed through GE techniques in general (nor was it asked to do so).
But is the EU’s GMO regulatory system fit for purpose?
1 The EU regulatory framework regarding genetically modified organisms (GMOs) was established in 1990. While the legislation has been revised, the definition of GMOs has remained unchanged for over 30 years.
2 Unlike plants produced as GMOs, plants and products derived from GE are not easily detectable (no foreign DNA is introduced) and would give EU member states ‘an impossible’ traceability task, especially in terms of unknown GE plant products. This would make EU legislation on labelling and traceability unworkable. If GE techniques remain under the same controls as GMOs, they are unlikely to be widely used in the EU. The EU has already spent €300m on safety studies over a 25-year period, which concluded that GMO is not per-se riskier than conventional plant breeding technologies.
3 If the current situation pertains, it is likely that the brain drain will continue from the EU as our brightest students relocate to countries where GE can contribute to new innovations. The continued blocking of access to this technology could threaten the competitiveness of farming in the Farm to Fork era.
Further information around the EU study can be found here.
GE in other countries
Countries like Argentina, Australia, Brazil, the US and Japan have concluded that organisms developed with certain GE applications will not be regulated as GMOs. The UK government is of the view that GE should not be regulated as GMOs if the organisms produced could have been produced by traditional breeding methods. It is currently carrying out a public consultation on GE.
Are EU attitudes changing?
There is certainly an increasing interest in GE and GM technology. This could be driven by the part it played in the identification of the three vaccines now used for the Sars-Cov-2 virus pandemic. The AstraZeneca vaccine is labelled ‘recombinant’. In July 2020, the EU suspended (temporary derogation) some of its GMO regulations to fast-track the development of the coronavirus vaccines.
This was seen as hypocritical, as some of these vaccines use the same GM techniques that had been vigorously opposed for GMO crops by many EU member states, NGOs and politicians over the past 30 years.
Need to review the EU GMO system
One of the main issues with the current system is that decision-making has become highly politicised at EU level. This could continue to effectively prohibit the use of GE techniques in the EU and Ireland.
If this happens, the EU could lose these new GE tools for agriculture, sustainability, biodiversity and for biomedicine/public health purposes.
Member states must be aware of the role that GE/GMO technology is playing in the development of GM-derived COVID-19 vaccines. Therefore, EU member states should review the regulatory approval systems for GE technologies, so that all sectors of society – agriculture, environment and medical – can benefit from their potential.
The outcome of this Commission consultation (to be submitted by 30 April 2021) might offer an opportunity to provide clarification on foot of the ECJ judgment
In 2107, the Dutch government proposed that the GMO Directive should not apply to plants resulting from the use of GE techniques like CRISPR, provided these plants are at least equally as safe as plants obtained by traditional breeding. I suggest the Irish Government support this Dutch proposal. This is in line with the decisions taken by other jurisdictions globally, and will ensure legal certainty and the smooth running of global trade in agricultural products. This message needs to be communicated by the Irish Government at EU level and in the European Parliament through our MEPs.
The outcome of this Commission consultation (to be submitted by 30 April 2021) might offer an opportunity to provide clarification on foot of the ECJ judgment to ensure that the uncertainty around the status of organisms developed through GE can be addressed.
We must hope that the intransigence regarding GMO adoption in the EU for the past 30 years does not continue to blight the adoption of gene editing technologies.
If GE techniques like CRISPR are regulated as GMOs in the EU, this will deprive Europe of genetic potential to help fulfil many of its new strategy objectives.Because nothing has been added or taken away from the genetic code, these traits cannot be identified or policed. If the current interpretation of the law is not changed, the EU will continue to experience a brain drain while importing products produced elsewhere with GE technologies because they cannot be identified. * Dr Thomas McLoughlin worked as a research scientist with leading biotechnology companies and universities in microbial ecology/genetics for 20 years. He later worked as a senior scientist for the EPA (now retired) on the implementation of GMO regulations.
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