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EU Biotech Approvals? Its Déjà Vu Yet Again
USSEC chairman on EC limbo land
Laura Foell, US Soy Export Council (USSEC) chairman
Dear Readers,
It was famed U.S. baseball player, Yogi Berra, who coined the phrase – “its déjà vu all over again”. In January this year, the European Ombudsman found that between 2012 and 2014 the European Commission was guilty of “maladministration” by taking more than three and a half months before making a final decision on the approval of safety-assessed biotech events. Also in January, three soybean events completed the risk management process with no decision being reached by the member states. Now, four months have passed - and still no Commission decision. Yogi Berra’s phrase rings loud and clear with soy growers as they watch the current Commission fail yet again to authorize products within a reasonable time. For weeks, we and others have received assurances from the Commission that the three soybean events were ready for final authorization. Yet, there is no movement.
Unseasonably warm weather in the U.S. has brought forward planting decisions by soy growers, and many would like to plant the traits that are in Commission limbo land. This delay has affected planting decisions and caused uncertainty in the trade. This could ultimately result in market disruption and harm EU livestock and poultry farmers who rely on soy – an essential ingredient in feedstuffs. Some reports suggest the Commission is deliberately delaying approvals until a different piece of legislation on the re-authorization of a glyphosate is adopted by member states in late May. If true, such an approach would be counter to the EU’s legislative procedures and WTO obligations and would set an unacceptable and dangerous precedent.
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Growers in the U.S. and the rest of the Americas believe in science-based regulatory systems. The soybean events in question have been approved in major world markets with functioning regulatory systems. Crops derived from biotechnology have brought tremendous benefits to us as farmers through efficiencies such as being able to increase conservation tillage, and reduce diesel fuel and chemical use. Society also benefits through lower greenhouse gas emissions and the supply of safe and affordable food from biotech crops. Decisions delayed because of ever-changing requirements as part of EFSA’s assessments and political or administrative expediency, adversely affect trade, increase the cost of food, hamper innovation, sow seeds of distrust and undermine legislation. In short, the EU’s poor handling of its biotech regulatory system generates a general feeling of dysfunction. The Ombudsman also noted in her January report that “we very much look forward to the Commission approving products in compliance with its legal obligations.” However, the way these three soybean traits have been handled has completely removed all optimism.
Yours sincerely,
Laura Foell
Laura Foell is a soybean and corn farmer from Schaller, Iowa, and is also the Chairman of the U.S. Soybean Export Council (USSEC), which represents the interests of U.S. soybean producers, commodity shippers, merchandisers, allied agribusinesses and agricultural organizations in international markets.
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Quotes of the Month
“Agriculture in the EU should not become a museum; it should contribute to sustainable innovation.” Vytenis Andriukaitis, Health and Food Commissioner, 26 April 2016
“I believe that green movements will be in favour of transgenics." Prof. Marc van Montagu, sometimes referred to as the “father of GMOs”, 10 March 2016
“If we are to make the European economy more innovative, the key question is: How do we achieve a more evidence-based policy?” Marijn Dekkers, CEO of Bayer, 21 April 2016
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European & International News
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Maladministration continues
Commission delays GMO Authorisations
In an open letter, EuropaBio urges President Juncker to end the Commission’s maladministration on GM imports. It was sent on the day on which new Commission delays turned into clear maladministration, as defined in a recent European Ombudsman decision. We also published a press release describing how this maladministration is distorting markets: it is preventing North American and other farmers from accessing innovation. Canadian and US soy farmers are among those who have also publically complained.
Copyright: ValentinT
Development or Colonialism?
MEPs deny African farmers choice
The EP development committee “urges the G8 member states not to support GMO crops in Africa”, according to a report that was adopted by the committee in April. Over 16 million poor smallholder farmers in developing countries are very consciously opting for safe GMOs, where they are allowed to do so. That’s more than all EU farmers combined! Initiatives like “Water Efficient Maize for Africa” and others are addressing some of the most pressing problems faced by African farmers. South Africa, Burkina Faso and Sudan allow their farmers to grow certain GMOs, and a number of countries including Kenya and Uganda are considering it. Why not let Africans decide for themselves, rather than demonising a technology which has enabled a better life for millions? Read more here.
Copyright: CropLife International
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How to become a Farming Museum
New plant breeding techniques
Nine years after the Netherlands asked the Commission a “yes/ no” question, the reply is still outstanding. Do certain new plant breeding techniques such as gene editing lead to GMOs under existing EU law? The Commission convened Member States experts in 2008 who finalised their answer in early 2012, concluding that most techniques do not lead to GMOs. This conclusion has however never been published by the Commission. If the inaction continues, or if gene-editing is regulated as leading to GMOs, this would definitely turn the EU into an agriculture museum, as Commissioner Andriukaitis rightly warned. Other countries including the USA have given their green light for gene-edited crops such as maize and mushrooms. Several EU countries have also clarified that gene-editing and/ or CRISPR-Cas9 do not lead to GMOs: the German authority’s opinion on ODM and CRISPR-Cas9, also available in English & its FAQs; the Finnish authority’s on Arabidopsis produced with CRISPR-Cas9; Swedish authorities’ statement. And additional countries also appear inclined to support these opinions. Meanwhile, EU farmers and grain traders have spoken up in favor of innovation.
Intellectual property
Farmers benefit
Modern plant breeding needs and benefits from the protection of both plant variety rights and patents. Farmers benefit too. Remarkably, most of the social welfare coming from patented innovations actually accrues to farmers, as is the case with the patented hybridisation technology called Ogura, which was developed by the French public research institute INRA. The technology is used to make Oilseed Rape hybrids with higher yields. A thorough analysis of the socio-economic effects of the patented Ogura technology showed that 75% of the total benefit coming from the patented innovation (estimated at € 1.0 billion) accrues to farmers (50%) and to processors and end consumers of livestock products (25%), as opposed to only 25% for the technology developer. The complementarity and interface between patents and plant variety rights will be at the core of the discussions during the symposium 'Finding the Balance' convened by the Netherlands' EU Presidency on 18 May 2016 in Brussels. Check out our position papers, our IP brochure and the resources on the IP52 website.
China backs GMOs
According to the Economist, China’s president said that his country must “occupy the commanding heights of transgenic technology”, and the Wall Street Journal reports that “China signals speed on GMOs”.
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Copyright: sunyaluk
 France: Ban ruled illegal yet again
In April, the highest French court declared the national ban on cultivation of GMO maize illegal. This is already the fourth time that the French government’s bans have been revoked by the highest national and European courts. The government failed to demonstrate any risk. GM crops are as safe as conventionally bred crops, and insect resistant maize demonstrably decreases mycotoxins, which are a proven health risk. In 2014, 30-50% of the French maize harvest exceeded the maximum legal mycotoxin content, and the French government officially asked for an exemption. EuropaBio has repeatedly emphasised that a license to ban cultivation of GM crops is a stop sign for innovation, turning the EU into a farming museum.
France: «biotechnologies vertes» available on-line
IBV has issued the first example of its redesigned newsletter on green biotechnologies, «biotechnologies vertes», which contains interesting information about several biotechnology related topics for all relevant stakeholders, including politicians, farmers’ associations and think tanks.
 Belgium: GMOs “threatened by extinction”
Francesco Vanderjeugd, Member of the Flemish Parliament, points out that important Flemish knowledge and scientific expertise related to GMOs is disappearing as more and more companies close their biotech divisions. According to Vanderjeugd, this is due to the EU’s negative attitude towards agricultural biotechnology which is ‘destructive for the future of our agriculture’.
 Romania: Soybean foolishness
Romania, like most EU countries, imports large amounts of GM soybeans for its livestock today. The imports are cheaper than domestic, conventional production, due to the increased efficiency of GM- crops, and the fact that Romanian farmers were disallowed to grow GM soybeans upon EU accession. The national daily PUTEREA/The POWER, shows that if GM soybeans were approved for cultivation in the EU, the competitiveness of Romanian farmers would be boosted: “The Brussels Dictate: Romania should get its soybeans from America, or how EU is fooling itself about GMOs”.
 UK: Field Trial of GM Camelina
Rothamsted Research has received consent for a field trial of GM camelina plants. The goal is to determine if the plants are able to make significant quantities of omega-3 long chain polyunsaturated fatty acids (LC-PUFAs) and astaxanthin in the seed of the plant under field conditions. These omega-3 fatty acids have been shown to protect against coronary heart diseases. Astaxanthin is a pigment used as a feed additive in fish farming.
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 Germany: Demonization over sustainabilitySwiss pro-organic scientist Prof. Urs Niggli dared to emphasise the potential of technology in plant breeding in TAZ – an unacceptable blasphemy for purist organic movements. Sueddeutsche Zeitung commented “Many organic farmers live well off the demonization of modern breeding techniques. (…) But this escalation also sheds light on the rejection of innovation promoted by many in the organic movement, which can sometimes even harm the environment”. In FAZ, Emmanuelle Charpentier highlights the significant potential of the genome editing technique known as CRISPR, saying that Europe is too strict regarding genetic technology. For comprehensive TV broadcasts on CRISPR and revolution in plant breeding, see 3Sat 1 and 3Sat 2.
Germany: Innovation for bioeconomy
The head of the German biotech association Dr. Ricardo Gent discussed the agricultural challenges resulting from increasing global demand for food, feed, fibre and fuel. He notes that these production demands cannot be met with conventional plant breeding techniques, but will require agricultural biotechnology. If Germany and the EU continue to hinder innovation, other parts of the world will more effectively develop the bioeconomy.
Germany: Still busy banning
On 14-15 April, the Conference of German Agricultural Ministers seems to have agreed on a compromise for opt outs on GM cultivation. The German Länder and the Federal State will take joint responsibility: if a majority of Länder demand an opt out, this will lead to a national opt out.
 Portugal: Left set to ban GMOs on the Azores
The left Portuguese party Bloco de Esquerda (BE) advocated a total ban on cultivation, imports and marketing of GM plants on some Azores islands. In 2012, the Azores approved a regulatory framework for GM crops, but the BE party claims that “there are risks to health and ecosystems”.
Portugal: Pro GM voices
Using GMOs is a political decision, argues Prof. Wayne Parrott, University of Georgia (USA). He believes that there is no scientific justification for Europe being left behind in the use of GM technology. At the Institute of Chemical and Biological Technology (ITQB), in Oeiras, Portugal, Parrott criticized the EU regulatory system, reminding us that we already live in a GMO world. In a separate opinion piece on the GM revolution, the author, Lopo de Carvalho, defends science and GM crops, noting that they protect EU farmers, the food and feed chain, the economy, consumers and the environment.
 Poland: Banning GM feed risks economic chaos
The Polish Feed Chamber and a number of other trade associations convened a conference on GM feed materials on 18 April 2016 in the Polish Ministry of Agriculture to advocate lifting the foreseen ban on imports of GM feed. The Ministry of Agriculture is expected to propose delaying the ban by another four years. The Veterinary State Institute of Poland carried out a research project on GM feed materials and advised that there is no health risk for farm animals from GM feed. The Polish Poultry Chamber warned of the severe economic consequences that a ban on import of GM feed would cause. Read more here and here.
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New methods to develop quicker and more durable resistance
An article in Nature Biotechnology presents a new, quick approach to isolating disease resistant genes from wild relatives of domesticated crops. These genes can then be used to achieve durable resistance against pests in commercial varieties. This technique appears promising for tackling plant pests such as late potato blight or wheat stem rust, which cause severe yield losses. Read more here.
Biotech helps millions in developing countries
The ISAAA report for 2015 continues to show that more farmers are now planting biotech crops globally than all EU farmers put together, on a surface that is larger than all EU arable land! Where farmers are given the right to choose, many continue to opt for GM seeds. The global growth of GMO uptake has been slowed, however, by regulatory barriers, especially in Europe which is on the way to becoming a farming museum.
Farmers’ benefits of over €130 billion
Brookes and Barefoot have published their yearly results on the economic impact of GM crops at farm level in the journal GM Crops & Food. They conclude that the net economic benefits amounted to €15.5 billion in 2014 and over €130 billion between 1996-2014 for farmers in developed and developing countries. The gains were derived from yield gains and to a lesser extent from cost savings.
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Perception: Are we gene’ophobic?
Ventura et al. published an analysis of how visual communication influences public perception of GMOs. The authors suggest that exposure to scary images such as the most prominent Google result images could be a factor that affects the negative perception of GMOs in Italy. Meanwhile, a new official survey (p. 41) finds that Germans have become somewhat more open to GM technology, and that the share of technology supporters is highest among well-to-do, young, male city dwellers. Read more about public perception in our factsheet “GMO – do we judge before we know?”
Copyright: pa3x
No allergenicity from Bt Cry proteins
Insect resistant GM crops producing Bacillus thuringiensis (Bt) crystal (Cry) insecticidal proteins are widely cultivated globally. A critical analysis of all existing literature regarding the potential immunostimulatory effect of Cry proteins potentially resulting in allergic reactions, shows that Cry proteins are expressed at very low levels in GM crops and are extremely unlikely to function as adjuvants. Hence, as confirmed by many regulatory agencies worldwide, no safety concerns related to allergenicity have been identified for these crops.
Miscellaneous
- New genetically engineered potato approved for Canada, (CBC News)
- Bayer sees gloomy GM picture in Europe (Farm Weekly)
- Biotech Benefits: Drought- and Salinity-Resistant Crops (Food Insight)
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GMO import bans would cost Europe dearly
The facts already show that the EU benefits greatly from GM trade. But what would happen if Europe were deprived of GM crops? This new factsheet shows that there would be major economic repercussions for the EU and its member states, including farmers and consumers alike. One year after the EU Commission put its ‘opt-out’ proposal forward, we urge the European Commission not to let the EU denigrate into a costly Patchwork Europe! Members of the EU food and feed chain coalition have elaborated further here.
Biotech party across Europe!
European Biotech Week is back this year between 26 September and 2 October! The previous three editions featured over 300 events and activities across Europe, increasing dialogue and understanding of biotechnology. Join the conversation at http://www.biotechweek.org/!
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EuropaBio in the media
In our latest articles in the Parliament Magazine (p. 30) and in European Seed, we raised attention to the European Commission’s systemic maladministration of the established EU system for GMO import approvals. In the next (May) edition of Pan European Networks: Government, we will expand more broadly on our concerns around regulatory timelines in the EU, which are greatly hindering innovation and competitiveness.
EuropaBio engages with EUFood Chat
@EuropaBio contributed to the 25 April #CAPonTheGround @EUFoodChat sharing some views on #innovation for #growth and #jobs in #agriculture. The truth is that the CAP is a long way from effectively helping EU farmers, which, overwhelmingly, are prevented from having access to GM crops. Follow us @EuropaBio , and get your #innovation on!
Find out more about GMOs here:
 
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Selection For Your Agenda
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EuropaBio is the European Association for Bioindustries. Our Secretary General is Nathalie Moll. The Green Biotechnology Team are Beat Späth, Pedro Narro, Delphine Carron, Violeta Georgieva and Chris Gallasch. For more information and our contact details, please check http://www.europabio.org/.
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