The Genetic Technology (Precision Breeding) Act [PBA] has now received royal assent. What does this legislation mean in practice?
The Genetic Technology (Precision Breeding) Act establishes a novel framework in the UK for risk-assessing, releasing and marketing precision bred plants and animals. While UK press coverage of these developments has focussed on gene-editing of pets, passing the PBA is important. It provides a legal framework for novel products previously caught in regulatory ambiguity, because existing regulations did not cover new biotechnologies. It also indicates future regulation post-Brexit, while we wait for changes to retained EU law to be adopted.
Precision breeding is the ability to use gene editing technology to make targeted changes to the genetic code of organisms, like traditional breeding techniques, but much faster. The technology is seen as essential to ensure UK food security, while positioning the country at the forefront of global agri-innovation. It involves using specialised enzymes to edit genes at specific points - at present, this can be done with technologies like CRISPR and TALEN.
Genetic editing is not the same as genetic modification. It does not involve transgenics – genes movement between species. Gene-editing provides an alternative to ensure the resilience of crops, thus contributing to the stabilisation of global food markets - price fluctuations have a 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 for precision breeding products under this act, raising questions about consumer protection. Formal guidance from the UK Food Standards Agency (FSA) about the labelling for precision breeding products is yet to be issued. Equally, potential for global trade-distorting effects appear unmitigated, as unlabelled gene-edited foods would not, in principle, be granted market access in WTO member states with more stringent labelling requirements for such foods. The UK government views precision breeding as a rapidly evolving technology requiring regulation to be responsive, effective, accessible and transparent.
Future-proof, agile laws like the PBA might 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, as well as public health.
Significantly, the new act also provides a legal basis for gene-editing farm animals in England, subject to MPs satisfying themselves that the technique involves no animal suffering. The use of animal welfare as a standard to scrutinise the legality of a parliamentary act is a welcome development in the broader discussion of animal sentience and their legal standing within constitutional frameworks.
Ethical considerations require attention for this act not to suffer the PR disaster of early days in the transatlantic genetically modified organism (GMO) wars. A careful risk communication strategy, coupled with robust consultation mechanisms will help ensure public trust in government action, and foster public acceptance of the new products. Indeed, there is an impending need to avoid the disastrously long legal battle, when GMOs produced in the US were prevented from accessing EU markets - a ban that continues.
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 the lack of consultation with devolved governments while preparing the bill, potentially jeopardising the legitimacy of the new products. 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.
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, where latest prevailing scientific opinions, confirm that gene-editing falls within the EU GMO regulatory regime. Crucially however, opinion cautions that, as technological developments advance at pace, the current EU GMO regime is not fit for purpose.
Back in England, the PBA is performing anticipatory, progressive risk governance by foreseeing its application to technological methods that may arise in the future. The PBA deploys an iteration of the doctrine of substantive equivalence for assessing food safety. Widely used in Canada and the US, this doctrine operates on a presumption of safety that focuses on product, rather than the EU’s precautionary principle, which focuses on process.
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. 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. Through this lens, the UK is de-coupling from the EU in three distinct [A]cts: it is 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.
Future-proof, agile laws like the PBA might 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, as well as 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.
This post was first published in the International Economic Law and Policy Blog on 5 April 2023 and on the Birmingham Law School Research Blog on 13 April 2023. It is reproduced here with permission.
Assistant Professor in Intellectual Property and Innovation Law
Biographical and contact information for Dr Mariela de Amstalden, Assistant Professor in Intellectual Property and Innovation Law.
