Opinion: The Genetic Technology (Precision Breeding) Bill
Posted on May 2, 2023 by Peter Lund, University of Birmingham
The new Genetic Technology (Precision Breeding) Bill has now become law, which will enable the development and marketing of genome-edited organisms in England. But what does this mean for microbiology? In this blog, Professor Peter Lund shares his thoughts.
On 23 March 2023, King Charles III – well known in his former incarnation as the Prince of Wales for his outspoken opposition to genetic modification – gave Royal Assent to the Genetic Technologies (Precision Breeding) Bill. Whether it was the strength of the scientific case that persuaded him to give his assent, or whether he was compelled to do so by a long history of constitutional practice, we may never know – though we can guess. But the upshot of this new Act of Parliament, now part of UK law, is that a subset of organisms that were previously designated as genetically modified (GM), and hence subject to a very stringent regulatory regime, are now redefined as “Precision Bred Organisms (PBOs)”. These organisms will be those where, in the words of the Act, “every feature of its genome that results from the application of modern biotechnology could have resulted from traditional processes”, traditional in this case being very broadly defined to include not only classical breeding but also the use of random mutagenesis (chemical or X-ray) plus a range of in-vitro methods such as fusing cells from different varieties, and inducing changes in the number of chromosomes. In principle PBOs will in future be regulated in the same way as all other new varieties that producers wish to bring to the market, no matter how they have been made. The Act moves the UK closer to countries like the USA, which regulate food and feed on the basis of their traits rather than by how they were produced in the first place. However, it puts us (at least for now) out of alignment with others, including most European countries, as EU law defines any organism produced via direct manipulation of the genome as being GM, although somewhat illogically organisms produced by random chemical or X-ray mutagenesis are excluded from this. But how does all this affect microbiologists?
The short answer to this is “not at all” – except that as UK consumers we may, in the foreseeable future, be eating food derived from CRISPR-edited plants, where the genome has been altered in a targeted, deliberate way. This is because a key feature of the Act is that it applies only to animals and plants, defined with agreeable scientific rigour in Section 2 of the Act; micro-organisms are not included. In political terms this may have been a sensible move. Members of Parliament are not by and large known for their scientific acumen, but they do know what plants and animals are, and the debates that took place during the passage of the Bill might have been much more fraught if bacteria (with their association in most people’s minds with disease) had been included, and this might have made the Bill far more contentious than it was. But the consequence is that anyone wanting to release into the environment a micro-organism produced using any kind of recombinant DNA technology still has to master the GM regulatory maze, and this may act as a brake on development for some much-needed technologies.
For now, GMOs, with the exception of the newly-designated PBOs, are regulated in the UK under laws that were enacted while we were still members of the EU. (This introduces a significant element of uncertainty, given Jacob Rees-Mogg’s Retained EU Law Act to remove all EU law from the UK’s statute books by the end of 2023 has already passed its first stages in the House of Commons – but that’s another developing story). GMOs are regulated differently depending on whether they are going to be used in contained conditions, which covers the vast majority of research in laboratories as well as industrial applications like the production of insulin or rennet from GM bacteria, or whether they will find their way into the natural environment. Further regulations apply if they, or anything derived from them, are going to be eaten by us or by farm animals. The regulatory route for organisms that will be deliberately released is long and far more restrictive than for any organism developed using a non-GM route. This in turn can lead to apparent absurdities: a micro-organism with a simple gene deletion which has been engineered in the lab, for example, would be legally different from, and required to jump a much higher regulatory barrier than the same organism in which the exact same deletion had occurred in nature, even though the two would be genetically identical.
The environmental release of a few GMO micro-organisms has already been approved (the appropriate authority in this case being the Secretary of State for Environment, Food, and Rural Affairs, currently Thérèse Coffey), although all these approvals relate to small-scale clinical trials. Generally, environmental release will be a natural consequence of their use as vaccines or as harmless competitors that reduce colonisation by more harmful relatives, and the bacterial species concerned include non-pathogenic derivatives of strains of Bordetella pertussis, Neisseria lactamica, Streptococcus pneumoniae, and typhi and paratyphi serovars of Salmonella enterica. In addition, a number of GM viral vaccines to improve human or animal health have been approved; these too are likely to find their way from their human or animal hosts into the external environment. It might be argued that some of these would be classified as PBOs had micro-organisms fallen within the remit of the new law, but the definition given above is hard to apply to micro-organisms: what constitutes a “traditional process”, for example, when bacteria are being considered? But looking ahead, I’d suggest that the increasing pace of development of GM micro-organisms that will either enter the environment as a consequence of their use (e.g., as vaccines, or as probiotics) or be deliberately targeted to the environment (e.g., for bioremediation or biofuel production), means that current GM legislation will be repeatedly tested, perhaps beyond breaking-point, by these novel applications. The passage of the PBO Bill is the first change in GM regulations for many years in the UK, and it means the time may have come for a new and careful look at how GM micro-organisms are regulated, particularly with regard to their release into the environment.
This won’t however be a simple task. Micro-organisms with their small genomes are of course far easier to characterise genetically than plants or animals, and the tools for their manipulation are mostly well established. Manipulations can range from simple deletion of single genes to wholesale construction of novel metabolic pathways or even complete genomes: this combines a huge potential for novel applications with uncertainty about how such micro-organisms might behave in the natural environment, even before taking into account the enormous extent of movement of DNA between unrelated bacterial species. And the fact that many people believe that the global COVID-19 pandemic was a consequence of human manipulation of a coronavirus genome means that, even if this is ever definitively proven not to be the case, public opinion may be hostile to any attempt to make regulation of GM micro-organisms less stringent than it currently is. The Microbiology Society is, I think, ideally placed to play a leading role in any such review, and should start to develop policy positions in this area so that new microbially-based technologies that can benefit human and animal health or be deployed as part of the much-trumpeted green economy are brought to fruition promptly and safely.