EU Court of Justice Ruling on Plant Breeding Innovation

On July 25 the European Union (EU) Court of Justice ruled that plants resulting from some of the latest plant breeding innovations, including targeted mutagenesis (i.e. gene editing) such as CRISPR, are considered genetically modified organisms (GMOs). It is important to note that the ruling is an interpretation of existing EU law. It is not a scientific assessment, nor an expression or statement of policy by the EU’s political bodies. This interpretation is at odds with decisions and interpretations made elsewhere in the world, including here in Australia, US, South America and Israel.   Summary  The EU Court of Justice has issued its long-awaited decision on the regulatory status of plants resulting from some of the latest plant breeding innovations. This determines whether they can practically be taken up by researchers, universities, breeders and farmers in the EU. The ruling’s line of argument is based almost entirely on the breeding process (technology involved) and does not differentiate between product categories based on the outcome of these processes. The ruling puts forward a purely process-based approach after an EU specific point in time (2001; the time of adoption of the EU GMO Directive). Organisms obtained by means of mutagenesis which have “conventionally” been used and have a long safety record will continue to be exempt. This exemption would apply to the “classical”, random mutagenesis breeding methods using chemicals or radiation. In Australia, the current review of the Gene Technology Regulations and the National Gene Technology Scheme will provide regulatory clarity on plants and animals derived from the latest breeding methods for Australian industry and public-sector researchers. ABCA’s Statement of Principles on Regulatory Oversight of New Breeding Techniques is available on the ABCA website.   Further information: The Court of Justice of the EU Ruling on Case  C-528/16 and associated Press Release. Media releases from CropLife Australia, EuropaBio and the European Seed Association are also available. Links to some of the media coverage overnight on the EU decision on gene editing techniques: EURACTIV - Industry shocked by EU Court decision to put gene editing technique under GM law: https://www.euractiv.com/section/agriculture-food/news/industry-shocked-by-eu-court-decision-to-put-gene-editing-technique-under-gm-law/ Reuters - GMO rules cover plant gene editing technique: https://www.reuters.com/article/us-eu-court-gmo/eu-top-court-says-mutagenesis-falls-under-eu-gmo-rules-idUSKBN1KF15L Politico - EU’s top court tightens controls over controversial new GMO techniques: https://www.politico.eu/article/mutagenesis-genetically-modified-organisms-eu-court-opens-door-to-certain-contentious-plant-breeding-techniques/ The Guardian - Gene-edited plants and animals are GM foods, EU court rules: https://www.theguardian.com/environment/2018/jul/25/gene-editing-is-gm-europes-highest-court-rules Yahoo - EU court extends GMO rules to new techniques: https://au.news.yahoo.com/eu-court-extends-gmo-rules-techniques-165643988--spt.html Wired – EU ruling could slow Africa’s push for Crispr crops: https://www.wired.com/story/european-ruling-could-slow-africas-push-for-crispr-crops/ Nature - CRISPR plants now subject to tough GM laws in European Union: https://www.nature.com/articles/d41586-018-05814-6 DW - EU risks being left behind after GMO ruling: https://www.dw.com/en/opinion-eu-risks-being-left-behind-after-gmo-ruling/a-44825520 -------------------------------------- Probably unexpected, and does not reflect on the science, but rather a legal interpretation. The media links above would say it all - most if not all are a bit stunned at the decision. No doubt the anti GM urgers will  applaud the decision, but it will have wide implications - or will it?

GMO Truth - Confessions of an Anti GMO Activist

This is a classic case of about face, with a former strident anti GMO activist now an active campaigner for GMO crops, Mark Lynas and his book "Seeds of Science" is published today, June 26.

The article is in the Wall Street Journal - about as pro business as it comes, on June 23 2018.
This is the link - https://www.wsj.com/articles/confession-of-an-anti-gmo-activist-1529679465

It might be behind a pay wall, but my guess it will be leaked...... and as I could read it now, it might not be unavailable anyway, as it was a few days ago.

A strong case for using GMO seeds and well written.

The case for more serious embrace of the technology is strong, and with newer techniques including the CRSPR technology of gene insertion using material from the same  or very similar species, it now is not even treated as a GMO in many countries plant varieties registration systems.

This article opens the potential for improving plant science and crop yield and overall performance,especially disease and insect resistance and follows up on a recent article by Bill Gates on similar roles for GM crops.  

Cannot Stop the Advance of GM Technology

Agricultural Biotechnology Council of Australia (ABCA) chair Ken Matthews says some Australian governments are “gutless” when it comes to giving farmers access to genetically modified (GM) crops.

The former secretary of both the Australian agriculture and transport departments made the no-nonsense observation in a detailed outline of global and domestic attitudes on biotechnology at the National Farmers' Federation Congress in Canberra last week.  

Mr Matthews summed up by saying Australia suffers from not having a more objective, science-based discussion about agricultural biotechnology.  “It’s really important that Australia has practicing farmers speak up for agricultural biotechnology because it’s practicing farmers that will be persuasive.”  The ongoing anti-GM campaign is one of the “big risks” facing the technology’s development, he said.

“There is a great suspicion of science and scientists in public debate in Australia and there has been a very effective campaign by NGOs (non-government organisations) which has influenced public opinion.

“As a result, what worries me is that environmentally responsible farmers - who tend in many other areas to be leaders of farm opinion - can often be ambivalent about GM.  “The pro-GM constituency among farmers is therefore not as strong as it could be in Australia.”

Governments need to lead

Mr Matthews said attitudes held by the general public, consumers, environmentalists and media were also central problems in the GM debate.

But his strongest criticism was reserved for various governments that refuse to allow GM crops to be cultivated, despite overwhelming scientific evidence.

“Some governments in Australia are – and I use this word carefully – gutless,” he said.

“There are total bans on GM in South Australia, Tasmania and the ACT,” he said.

“There are moratoriums in WA and NSW but there are certainly exemptions for that. In my view they (total bans) aren’t rationally based; they aren’t properly founded in science.

“Those moratoria need to be ended and we need to avoid further mandatory labelling requirements, unless they can be justified.”

Hinting at the recent high profile legal case involving neighbouring organic and GM farmers, Steve Marsh and Mike Baxter in Kojonup WA, Mr Matthews said the problem with reconciling organic standards and GM crops also “needs to be tackled”.

He said there were three inescapable truths about biotechnology: the first being that it provides a critical opportunity to lift the productivity, profitability and sustainability of Australian agriculture over the next 20 years.

Secondly, he said biotechnology was critical to meeting rapidly rising global food needs. 

And thirdly, biotechnology will inevitably continue to attract “suspicion and opposition” in some community sectors, slowing its development.

Mr Matthews said that opposition was based on four key concerns: food safety; environmental damage; “agrochemical industry domination” and “a roundup of ethical and religious issues”.

However, he said science delivered a very clear message about the safety of GM technology.

GM safety scientifically proven

Mr Matthews said more than 100 of the world’s independent science oversight bodies, including “very authoritative and credible organisations” in the US and Europe, shared a consensus that GM crops are “as safe as conventional varieties - and often safer because of the extensive approval process they need to go through”.  “The scientific evidence is overwhelmingly in favour of GM safety, assuming that we continue with the sound regulatory processes that we have,” he said.  “There have now been 3 trillion meals (consumed) involving or including GM and there’s been not one recorded case of harm.  “There have been 70 billion animals which have been feeding on GM feed of some sort, and not one recorded case of harm.”

Mr Matthews said a recent European review of over 1700 scientific studies around the world about environmental impacts of GM concluded that there was little or no evidence GM crops caused negative environmental impacts.

“To me, as a student of public policy, it’s really interesting that the environment movement is very keen for science to be heard in the climate change debate - but where the science is very clear, no one seems to want to know about biotechnology,” he said.

Mr Matthews faced a question from the floor at the NFF Congress from NSW Farmers executive councillor Gai Marshall, referring to the controversial Seralini rat study on GM corn, which purported to find the GM feed caused tumour growth. Ms Marshall said she wasn’t against growing GM but wanted to see greater traceability.

Mr Matthews said the Seralini piece of science had been retracted. “It has been rejected, it has been withdrawn,” he said.  “The peer review, the second time around, found it totally discredited.”

A solution to global food security?

Mr Matthews said the problems GM could solve were “unprecedented in history”.

He said there are huge farm business opportunities from potential GM products like self-fertilising plants that could “revolutionise agriculture and certainly would decouple agriculture from the oil industry”.

GM crops also had a key role to play in aiding the future food demand task as the world’s population grows from 7.2 billion now to 9.6 billion by 2050, with decreasing land and water to develop globally - 800 million people already go to bed hungry each night and 1 billion people are chronically undernourished, he said.

“In the meantime, if I can be a bit provocative, there are some pretty comfortable western based NGOs which continue to oppose and to slow down biotechnology, on non-scientific, without evidence grounds,” he said.

Mr Matthews said a striking example of that argument was the fact 250 million children are currently suffering from vitamin A deficiency but GM food crops with existing solutions “are having trouble getting mobilised”.  “Norman Borlaug, said to be the father of the green revolution, said once that if the naysayers do stop agricultural GM they might actually precipitate those famines and crises they’ve been predicting for years,” he said.

Mr Matthews said the technology’s uptake was unprecedented, with 79 per cent of global soybean area and 70pc of global cotton area now GM.  “Growers are certainly not changing their mind and going back after they trial GM,” he said.

“Over the last 200 years there have been several waves of innovation in agriculture such as mechanisation, conventional plant breeding, chemical fertilisers and chemical herbicides.

“But none of them has been adopted as rapidly as GM seeds and I can tell you that animal-based GM is coming up very fast behind them.  “One eighth of global farm land is now GM, so this is a sort of mega bus that will not be stoppable.”


Mr Matthews said GM offers varieties with production benefits like faster growth rates and yields, drought tolerance, pesticide reduction and nutrient efficiency.

He said exciting work is also happening to generate varieties with consumer and health benefits like foods with fewer saturated fats, zero allergens, increased dietary fibre, reduced natural toxins, higher protein levels, built in vaccines, cholesterol management, and vitamin A.

“Benefits do flow to big biotech companies but perversely the regulatory costs - as a consequence of pressure from the opponents of GM - now make approvals just out of reach for anyone but the big firms,” he said.  “As an example, a single new GM trait may now cost $139 million, including $35 million just for the approvals part of that, and around the world it takes five-and-a-half years on average to gain a single new approval.

“Are those costs and time problems squeezing out public good innovations such as environmental public health innovations or small market GM innovations?”

Need to build trust

Mr Matthews said Australia grew GM canola and GM cotton and had great strengths in the area, with a world class regulatory system and plant breeding expertise.

But he said a three-part plan was needed to help overcome the slow progress of biotechnology development.

He said a constituency of biotechnology supporters was needed to build understanding of the potential benefits to farmers, consumers, the environment and society as a whole.  “We need to build community confidence and trust in Australia’s regulatory arrangements,” he said.  “We do need to be respectful of ethical concerns about biotechnology, but at the same time we need to give voice to the beneficiaries, and I think of those kids in Africa.

“When people are talking grandly about ethical concerns about biotechnology I worry about starving kids in Africa.  “We need to focus research more on benefits to consumers, to the environment, to society and we need to find some champions.” 

[ based on an article in the online edition of Qld Country Life 4 Nov 2014]