Biotech lobby’s push for new GMOs to escape regulation
Original source: Corporate Europe Observatory
The biotech industry is staging an audacious bid to have a whole new generation of genetic engineering techniques excluded from European regulations. The pending decision of the European Commission on the regulation of these so-called ‘new GMOs’ represents a climax point in the ongoing below-the-radar attack by industry on GM laws.
The EU’s GM regulations have long been a thorn in the biotech industry’s side. For their lobbyists, the Commission decision presents a unique opportunity to twist the interpretation of these rules – including the very definition of a GMO – so as to exclude the new genetic engineering techniques from their scope. This goes alongside ongoing industry attacks on the application of the precautionary principle – the basis of EU GM regulations – to novel food production techniques.
New genetic engineering techniques, which have emerged since Europe’s GMO law was introduced in 2001, are currently being applied by developers to food crops, trees, farm animals and insects. If the industry lobby campaign is successful, new GM organisms and foods – produced by techniques including oligonucleotide-directed mutagenesis (ODM), agroinfiltration and zinc finger nuclease technology (ZFN) – could enter the environment and the food chain untested, untraceable and unlabeled. Dozens of patents have already been filed in this field by the big agrochemical corporations like Bayer, BASF, Dow Agrosciences and Monsanto.
Due to widespread consumer rejection of GMOs, invisibility is vital for the commercial success of any new genetically engineered product in Europe. Their unregulated mass release could however have far-reaching consequences for the environment, food safety and consumer choice. Therefore, calls from farmers and environmental groups to regulate the new GM are increasing. The techniques in question each bring their own set of risks and uncertainties. Technical reports and legal analyses by government bodies and NGOs have concluded that GM 2.0 should not escape the EU GM regulations.1 Whilst some risks are similar to those associated with GM 1.0, there are also serious additional concerns.2
To further its cause, industry has set up a dedicated, EU-level lobbying vehicle – the New Breeding Techniques Platform – with the mission of having as many of the new GM t echniques as possible excluded from EU GM regulations. This platform is run by Schuttelaar & Partners, a Dutch lobby and PR firm with a shady reputation for pro-GM lobbying. At the same time, individual companies have been pressing various European governments to clarify the legal status of the new genetic engineering techniques, while announcing plans to field trial them in those countries. Furthermore, certain governments have been actively advocating the deregulation of new GM techniques at the EU level.
The ongoing negotiations around the Transatlantic Trade and Investment Partnership (TTIP) are an additional source of political pressure on European decision makers. In this context, industry lobby groups have presented the regulation of new GM techniques as a trade concern to both US and EU officials,3 claiming that the innovative nature and competitiveness of the European plant breeding (read: biotech) sector is at stake.
After contemplating this question for eight years, the Commission finally plans to publish a draft decision in February 2016. This briefing, based on documents released by the European Commission following freedom of information requests, illuminates the efforts made over the past three years by the industry lobby to have the new GM techniques deregulated. In addition, a first case study highlights the Dutch lobby campaign for the deregulation of cisgenesis, and a second one looks at Canadian company Cibus’s push for the deregulation of its ODM oilseed rape.
2. A lengthy process
The European Commission turned its attention to the new GM techniques eight years ago, setting up a ‘New Techniques Working Group’ (NTWG) in October 2007 to assess whether the GM techniques listed above give rise to products falling within the scope of the GMO legislation. However, its final report showed that the working group was divided on the regulatory status of some of the techniques, therefore leaving the Commission with no clear plan of action.4
In parallel to the analysis carried out by this Working Group, the Commission requested opinions from the European Food Safety Agency (EFSA) about the risks posed by cisgenesis, intragenesis and Zinc Finger Nuclease 3, and whether existing risk assessment methods were adequate for evaluating them.9 10
In 2012, the Commission reported that it was working with member states to find the best way forward in clarifying the regulatory status of the new techniques.12 In a presentation to the European Seed Association, the Commission claimed to be looking not only at the legal aspects, but also at “safety considerations, the approach in third countries, the chances and risks involved, and the view of European plant breeders”.13
Just months later, at a meeting with the industry-led NBT Platform, the Commission had changed course. It was later clarified that due to “the absence of consensus amongst the main political EU actors, reflecting the public hostility to GMOs”, the Commission had opted for a legal guidance document interpreting Directive 2001/18, rather than for new legislation. This means that the European Parliament plays no formal role, and that member states are expected to follow the Commission’s recommendations. In the case of disagreement, the European Court of Justice has the final say.14
The Commission has time and time again postponed the deadline for delivering the legal guidance document. In response to the many queries from industry and member states on its progress, the standard response has been that assessing the new techniques in the light of Directive 2001/18 “… is complex and requires a thorough technical and legal analysis”.15
As the Commission indicated, the member states were divided. Certain EU governments, including the UK, the Netherlands and Germany, pressured the Commission to deregulate one or more of the techniques. The Netherlands for instance has invested considerable public research funding in promoting the cisgenic GMOs developed by Wageningen University, and the Commission has been pressured by Dutch Ministries, the Permanent Representation in Brussels, the national parliament, and Dutch MEPs. (See case studyOf apples and potatoes: the Dutch lobby for the deregulation of cisgenesis).
Not surprisingly, corporations have been itching to get started on field trials of the new GM crops. Between 2012 and 2014, BASF16 and the Canadian company Cibus (among others) approached several member states, including the UK, Sweden and Finland, to ascertain the regulatory status of one of the techniques – Oligonucleotide-Directed Mutagenesis (ODM) – and to obtain clearance to field trial ODM herbicide-tolerant oilseed rape without having to undergo the regulatory risk assessment required of GMOs. (See case study ‘Canadian company railroads EU decision making on new GM’).
This resulted in the Finnish government complaining to the Commission about the lack of clarity of direction on ODM, leaving the national competent authorities “in a legally challenging position” since they were obliged to respond to the companies.17 Helsinki gave the Commission an April 2014 deadline to respond, but again the Commission told them to be patient…