Dr Mariela de Amstalden (7 April 2023)
[Mariela is Assistant Professor of Law, currently on part-time academic secondment with the UK Food Standards Agency (FSA). While she has not been involved in this Act’s negotiations, any opinions expressed here remain her own.]
Last month, the UK Genetic Technology (Precision Breeding) Act [PBA] received royal assent. This act establishes a novel framework in the UK for the release and marketing of, and risk assessments relating to, precision bred plants and animals, including derived food and feed. While UK press coverage of these developments has been largely limited to the misleading headlines about gene-editing of pets, the passing of the PBA is important on at least two main accounts. It provides a legal framework for novel products that were previously caught in regulatory ambiguity, because regulations in force predated the new biotechnologies, while also offering a robust indication of future regulatory preferences post-Brexit in highly regulated sectors, all the while we await for changes to retained EU law to be adopted. I share a few thoughts below.
Food Tech as the New Normal: Is Precision Breeding a Genetic Modification (GM)?
Precision breeding refers, in essence, to the ability to use gene editing technology to make targeted changes to the genetic code of organisms, similar to traditional breeding techniques, but much faster than the latter. This type is genetic technology is seen as essential to ensure food security in the UK (recall the 2023 winter food shortages), while positioning England at the forefront of global agri-innovations. More specifically, genetic editing for precision breeding entails the use of specialised enzymes to edit genes at specific points in a given genome or DNA sequence -adding, removing or replacing them with precision. At present, this can be done with the use of technologies like CRISPR and TALEN.
It is premised on the idea that genetic editing is not the same as genetic modification. This qualification is important, because genetic modification entails a difference in the process and in the outcome: in the process because genes derived from unrelated species are introduced into an organism’s genome, and in the outcome because this introduction confers novel characteristics that could have not occurred naturally in that organism. In simpler words, gene-editing does not involve transgenics – genes movement between species. In the absence of other, non-technological forms of addressing the relentless effects of climate change on our food systems, gene-editing provides an alternative to ensure the resilience of crops, thus contributing to the stabilisation of global food markets, with price fluctuations having real impact on the lives of millions of people and their ability to access safe, sustainable and nutritious foods.
Interestingly, there are no labelling requirements mandated for precision breeding products under this act, raising questions about consumer protection and potentially misleading (or absent) information in the front of pack labels. Formal guidance from the UK Food Standards Agency (FSA) about the labelling for precision breeding products is yet to be issued at present. Moreover, potential for global trade-distorting effects appear to be unmitigated at present, as unlabelled gene-edited foods would not be, in principle, granted market access in WTO member states with more stringent labelling requirements for such foods – as it is the case in the EU for the time being. The rationale from refraining to require specific labels is partly an attempt to address the ‘pacing problem’ and partly an exercise of anticipatory policy-making. More precisely, the UK government considers that precision breeding is a rapidly evolving technology with equally advanced industry practices that requires a flexible regulatory framework to be responsive, effective, accessible and transparent.
Animals by Design, Ethics and Global Trade
Significantly, the new act also provides a legal basis for the gene-editing of farming animals in England, although it is subject to a favourable vote in Westminster: MPs need to satisfy themselves that there is no animal suffering in the application of the technique. The use of animal welfare as a standard to scrutinise the legality of a parliamentary act, while not new, is certainly a welcome development in the broader discussion of animal sentience and their legal standing within constitutional frameworks.
Ethical considerations need to be paid attention to, and different points of view engaged with, if this act is not to suffer the dreadful public relations example of early days in the transatlantic GMO wars. A careful risk communication strategy, coupled with robust consultatory, iterative mechanisms will be required to ensure public trust in governmental action, and to foster public acceptance of the new products if the intention is for these novel foods to display their potential benefits. Indeed, there is an impending need to avoid the disastrously long legal battle that unfolded in Geneva in times past, when genetically modified organisms (GMOs) produced in the US have been prevented from accessing EU markets, in a calculated gesture of non-compliance with WTO law. The ban continues to date. A 2018 joint statement issued by some WTO members with regulations that allow for gene-editing crops and animals, including Argentina, Brazil, Colombia, Canada, Australia and the US, indicates a willingness to pre-empt future legal challenges and ‘avoid arbitrary and unjustifiable distinctions’ between precision and conventional breeding techniques.
Closer to home, as a matter of free movement of goods within the UK, there would be no barriers impeding the transit of gene-edited products from England into Wales, Scotland and Northern Ireland – where precision breeding techniques for agriculture are still banned. Questions have been raised about consultation (or lack thereof) with devolved governments while preparing the bill, potentially jeopardising the legitimacy, or at least public acceptance, of the new products across the UK. Another layer of complexity is added by the Northern Ireland Protocol and the recent Windsor Framework, de facto requiring foodstuffs to comply with both EU and UK rules.
De-coupling from the EU in three [A]cts: Anticipatory Laws for Uncertain Futures
The new act breaks away from continental European ways, by appearing to prompt a regulatory alignment with the US, which in recent years has decided not to label gene-edited agricultural products. This is in stark contrast with regulatory frameworks in place across the EU, affirmed by a not uncontroversial ECJ decision in 25 July 2018 (Case C-528/16) that gene-edited crops ought to be treated as genetically modified organisms (GMOs). More specifically, the court was concerned with the ability of gene-editing to produce the same effects as transgenesis, and to generate those at a rate ‘out of all proportion’ to those resulting from conventional breeding techniques. Latest prevailing scientific opinions in the EU, presented in a 2021 European Commission study, confirmed that gene-editing as a new genomic technique falls within the EU GMO regulatory regime. Crucially however, this study cautioned that technological developments are advancing at pace, and that the current EU GMO regime is not fit for purpose, particularly as it applies to some of the most recent techniques like CRISPR. The acknowledgement of novel forms of regulatory oversight gained traction, and the Commission is expected to propose a new regulation for plants produced by certain new genomic techniques in the second quarter of 2023.
Back in England, and in a novel regulatory twist, the PBA is performing anticipatory, progressive risk governance by also foreseeing its application to technological methods similar to CRISPR and TALEN that may arise in the future. The new legal standard for future gene-editing technologies is rather lenient, demanding only similarity in the end result (i.e. consumer facing product) in that there must be no difference between a variety that could have been naturally produced, but which would have taken much longer under traditional breeding methods. In doing so, the PBA is engaging in and deploying an iteration of the doctrine of substantive equivalence for the assessment of food safety. Widely used in Canada and the US, this doctrine operates on a presumption of safety that focuses on the product, in contrast to the precautionary principle embraced in the EU, which primarily focuses on the process.
Relegating the precautionary principle to days past in favour of substantive equivalence is significant. This might very well be a watershed moment, whereby a post-Brexit UK moves towards regulatory instrumentalization as a tool to operationalise ambitious plans to promote innovation and incentivise the economy. This sends a clear signal that regulatory alignment with the EU is passé, embarking on a new trajectory that prioritises future-proof governance of sustainable, if disruptive technologies. In this way, the UK is choosing to embark on a high-risk, high-gain strategy that can prove successful, provided it has sufficiently robust safeguard mechanisms in place to mitigate the spill-over effects of regulatory divergence, and their inevitable geopolitical ramifications. Through this lens then, the UK is de-coupling from the EU in three distinct [A]cts: it is evidently asserting its regulatory autonomy, by contesting old, seemingly unfit for purpose EU paradigms for good (food) regulation, while breaking ground on novel anticipatory laws for uncertain futures. These thought-provoking developments merit further study, and build the basis of upcoming work on cellular agriculture law (Edinburgh University Press 2024).
Future-proof, agile laws like the PBA might well be precisely what the UK agri-food and innovation sectors require to catapult effective climate change mitigation strategies, ensure resilient food systems and conserve public trust (and public health) as we start to transition towards a post-Anthropocene era of circular bioeconomies. Perhaps even post-Brexit clouds can have silver linings, after all.
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This post was first published in the International Economic Law and Policy Blog on 5 April 2023. It is reproduced here with permission.
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