Genome editing in plants can deliver beneficial crop properties such as drought and pest resistance, but the resulting products are also feared by some to lead to health and biodiversity risks in the long term. On 29th April 2021, the EU Commission published its long-awaited report on new genome editing techniques, hinting at deregulation of products resulting from genome editing amidst accusations of aggressive biotech industry lobbying. In this blogpost, Pauline Phoa discusses the legal background to the Commission’s report, as well as some concerns about the way forward.
In 2019, the Council of the EU requested that the Commission draw up this report, and, if necessary, submit proposals for policy action, after a controversial ruling of the Court of Justice in July 2018. In this ruling, the Court had decided that new genome editing techniques (such as CRISPR), should fall within the scope of application of the EU’s 2001 GMO Directive.
‘Molecular scissors’ and the GMO Directive
The Directive defines a genetically modified organism as ‘an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination’. It includes an annex with a list of techniques, such as so-called ‘mutagenesis’, which yield organisms that are exempted from its scope of application.
The dispute before the Court of Justice arose because it was unclear whether mutagenesis techniques developed after 2001, such as genome editing, also enjoyed this exemption. Whereas older mutagenesis techniques involved exposing plants to ionising radiation or to chemical agents, causing more random changes in the plant’s DNA, new genomic techniques alter the genetic material of an organism by using a kind of ‘molecular scissors’. This creates specific breaks in the DNA strands, which can be repaired in such a way that a genetic trait is deleted, inserted, changed or silenced, creating a mutation in the organism.
No foreign DNA is inserted (in contrast to a very different technique called ‘transgenesis’) and it is this absence of foreign genetic material which makes it nearly impossible to detect whether an organism has been genome-edited or the mutation has been achieved through traditional breeding methods. As we shall see below, this has important ramifications for the labelling and tracing of the resulting products.
The Court’s judgment in 2018
In line with the precautionary principle, which is central to the EU legal order in terms of risk regulation and laid down in Article 191 TFEU, the GMO Directive requires a comprehensive risk assessment before an authorisation is granted to market GMO products, and continuous monitoring must be carried out during marketisation. Moreover, the important European values of consumer protection and consumer (as well as farmer) choice result in strict labelling and tracing requirements once a GMO product is released on the market.
In its reasoning, the Court took the view that exemptions to the GMO Directive must be interpreted strictly in light of these legal principles. It furthermore based its interpretation on the clarification given by the EU legislature in recital 17 of the GMO Directive, and ruled that “only organisms obtained by means of techniques/methods of mutagenesis which have been conventionally used in a number of applications and have a long safety record are excluded from the scope of that Directive”.
This means that products resulting from the new techniques developed after 2001, such as CRISPR, are considered GMOs – and that in order to put the products of those techniques on the market, producers have to comply with the strict EU rules.
The aftermath of the Court’s ruling
The judgment caused a stir, especially as Advocate General Michal Bobek had advised the Court six months earlier to adopt a more liberal reading of the GMO Directive.
Green activists celebrated the Court’s interpretation of the GMO Directive as a victory of the precautionary principle, referring to scientific studies that warn that genome editing can cause off-target effects (unintended changes in a plant’s DNA) with unforeseen consequences. Moreover, activists claim that there is no concrete evidence that genome-edited crops currently fulfill the lofty promises about their contribution to sustainable agriculture, and that conventional and safe breeding techniques may achieve similar results of optimisation. It is also important to note that the majority of European consumers want food containing GMO or genome-edited plants to be clearly labelled.
By contrast, stakeholders from the scientific community, as well as large corporations that develop and market GMO or genome-edited seeds, complained that the judgment would stifle innovation, putting the EU at a disadvantage in the global agrifood trade. Indeed, since the adoption of the GMO Directive only rarely had GMO or gene-edited seeds obtained the required market authorisation.
As the Council requested that the Commission carefully examine the Court’s ruling, there were three possible outcomes for which various groups lobbied. The Commission could either:
- Advise that all should remain the same, and that new genome editing techniques should be considered GMOs within the current regulatory regime;
- Advise that certain new genome editing techniques should simply be exempted from the GMO Directive, thereby largely ignoring concerns about long-term safety, as well as concerns about biodiversity, consumers’ freedom of choice, and the position of farmers in relation to big corporations that hold the patents to these seeds; or
- Take steps toward creating a differentiated regulatory regime for the new techniques, which would take account of these broader considerations. Indeed, any policy action or legislative proposal should be fully aligned with the EU Commission’s flagship European Green Deal, Biodiversity and ‘Farm to Fork’ strategies, but also with the EU’s Common Agricultural Policy, which is currently under negotiation. It is important to note that in these policy programs, a target is set to reduce pesticide use by 50%, to which use of genome-edited crops might contribute, but also an increase in the level of organic farming to 25% by 2030. Under the current regulatory regime, genetically modified crops do not qualify as organic.
Lobbying: a contest of ‘truths’ about genome-editing
The Commission’s report was preceded in March 2021 by a report of the European Group on Ethics in Science and New Technologies, which stressed that while genome editing technologies in plants might help to achieve sustainability and food security goals, they could also lead to the opposite result without appropriate and proportionate control.
The Ethics Group also pleaded for an adequate reflection of social and justice considerations, thereby supporting small farmers and those adopting more holistic, agro-ecological approaches. Furthermore, it warned against the greater industrialisation of the agri-food sector, which it blamed for increasing levels of unemployment and precariousness in agriculture. Accordingly, small companies and research organisations should also be able to develop and market new varieties and monopolisation of the production of seeds should be limited, if not prevented.
Anticipation for the Commission’s response grew even further with the release of a very critical report from Corporate Europe Observatory which uncovered a high level of corporate lobbying to deregulate new genome editing techniques and products. These ‘CRISPR files’ exposed a variety of lobby groups that have scientific backing, but also a very high involvement of corporate stakeholders in terms of funding and oversight. Elsewhere, another recent analysis by Brussels-based NGO Friends of the Earth Europe has shown that around 75% of input to stakeholder consultations came from agri-industry bodies, which have a considerable interest in deregulating genome-editing techniques. Most strikingly, this analysis of the Commission’s consultation process has also shown that twice as many questions were asked about the potential benefits of new genome-editing techniques than about their potential risks.
The Commission’s report: leaving the door ajar for deregulation
Rather than questioning the Court’s interpretation of the GMO Directive in the 2018 judgment, the Commission concludes that the lack of clear definitions of key concepts in that legislation, as well as recent developments in biotechnology, lead to undesirable regulatory uncertainty. According to the Commission, there are strong indications that the current GMO legislation is ‘not fit for purpose’ to regulate certain new genome-editing techniques and the resulting products. The Commission also highlights the potential of these new techniques to contribute to the achievement of the ambitions of the European Green Deal.
That leads us to the most important element of the report: the Commission adopts the position that the products resulting from the new genomic editing techniques are similar in terms of risks to conventionally bred plants. This opens the door to their deregulation, or at least to a much lighter regulatory regime. Moreover, notice how the Commission has shifted away from a focus on process or technique, which is central to the current GMO Directive, towards a focus on the product, which had been advocated by biotech lobbyists such as EU-SAGE.
EU lawmaking for futuristic crops – or corporate power?
The Commission’s report forms the basis for further discussions about the way ahead for gene-editing techniques, hopefully leading to the third option sketched out above: well-balanced rules that are coherent with the EU’s core legal principles of consumer choice and the precautionary principle, as well as other EU policies on sustainability and agriculture.
The first step will be an impact assessment, which will provide input for an adaptation of the risk assessment and authorisation procedures, as well as labelling and traceability requirements. Importantly, the Commission explicitly stated that applications of such new genome editing techniques in the agricultural sector should not undermine other aspects of sustainable food production, such as organic agriculture.
The revelations seen above about the involvement of lobbyists in the shaping of this policy and discourse confirm the problem of corporate involvement in science, as well as in the law-making process, as already highlighted by philosopher Michiel Korthals in his 2018 book ‘Goed Eten’ and Utrecht University researcher Herman Lelieveldt in his ‘De Voedselparadox’. Lawmakers need expert input to determine the truth about certain results and their risks, in order to make effective legal definitions and rules. However, if the experts not only disagree but have truly opposing views, how to make good policy and law?
The concerns raised by NGOs (and other stakeholders) about the concentration of powers in the hands of a few agri-food or agri-chemical corporations, are addressed in the Commission’s report only marginally. The Commission merely states that “the effects of business models and the patenting system” should be “investigated further”. Yet the risk of further industrialisation of the agri-food sector is (as warned by the Ethics Group) far from hypothetical, also since it looks like the subsidy schemes under the Common Agricultural Policy will continue to benefit industrial agriculture the most.
If new genome editing techniques are deregulated, we will have big transnational corporations who not only produce the fertilizers and the pesticides, but also the patented genome-edited seeds, as well as data gathering and mining software that farmers are encouraged to use as part of ‘precision farming’.
The dream of sustainable precision farming, advocated in the Commission’s Farm to Fork strategy, combined with high-tech seeds, may turn into a nightmare, not necessarily involving the mutated ‘Franken-food’ that some opponents warn about, but because of the risks inherent in having a few, very large corporate stakeholders’ interests involved in basically all levels of the agri-food chain.
The concentration of this complex market power in very few corporate hands, similar to the ‘Modern Bigness’ of Big Tech companies, may not lead to a prioritising of concerns for sustainability, biodiversity and consumer choice. The response of such large biotech stakeholders is usually: deregulate, and small and medium-sized enterprises will benefit more, as deregulation will ‘break open’ the market. However, we are far from certain whether this effect will actually take place in a market that is already largely captured by big players.