On March 23, 2023, royal assent was given to a statute passed by the British Parliament entitled the Genetic Technology (Precision Breeding) Act 2023. The new law aims to facilitate the utilization of precision breeding, which includes gene editing, by removing precision-bred plants and animals from the regulatory requirements applicable to genetically modified organisms (GMO’s).
As explained by the Research Briefing accompanying the Act, with traditional breeding, a desirable trait in the organism is replicated naturally. But results can take a long time. Genome editing, by contrast, “increases the efficiency of introducing single and multiple traits and can remove undesirable genes without removing nearby (genetically linked) desirable genes.” A widely known example of genome editing is CRISPR, the acronym for Clustered Regularly Interspaced Palindromic Repeats. In crops, proponents of genome editing argue that the process may shorten the 8 to 20-year development of conventional crop breeding to 3 to 4 years.
As it concerns farm animals, the asserted benefits of precision breeding are to improve animal husbandry or stock. As the Research Briefing observed, U.K. scientists using gene editing are working to develop pigs that are resistant to the Porcine Reproductive and Respiratory Syndrome, and U.S. scientists have used gene editing to produce a gene edited dehorned bull which has passed on the trait to offspring.
The Department for Environmental Food & Rural Affairs (Defra) summarized the four key policy changes made by the Act:
- Remove plants and animals produced through precision breeding technologies from regulatory requirements applicable to the environmental release and marketing of GMOs (Genetically Modified Organisms),
- Introduce two notification systems; one for precision bred organisms used for research purposes and the other for marketing purposes. The information collected will be published on a public register on GOV.UK.
- Establish a proportionate regulatory system for precision bred animals to ensure animal welfare is safeguarded. We will not be introducing changes to the regulations for animals until this system is in place.
- Establish a new science-based authorisation process for food and feed products developed using precision bred organisms.
Under prior U.K. law, precision-bred plants and organisms had been subject to the regulatory requirements applicable to GMO’s. Unlike precision breeding, genetic modification is a process whereby DNA from one species is inserted into another. According to Defra, the pre-existing regulatory regime, which had been derived from European Union (EU) law, was more than 30 years old and had not kept pace with scientific developments or the increase in knowledge of the environmental impacts associated with precision breeding technologies.
As noted in the Research Briefing, the Act was supported by farmer groups such as the National Farmers’ Union and the National Pig Association. The farmers viewed gene editing as a way to speed up the improvements that can be derived from natural breeding which will enable farmers to respond to the nutrition needs of an ever-growing population while tackling the climate crisis.
Animal welfare organizations, such as the Royal Society for the Prevention of Cruelty to Animals (RSPCA), voiced concerns over the new law. Among other things, the RSPCA was concerned that precision breeding had no history of safe and reliable use and that it could cause unpredictable and unintended changes to the genome. Compassion in World Farming (CIWF) argued that gene editing should not be used to make farm animals more resistant to what CIWF asserts are the health effects of intensive farming methods.
Interestingly, the scope of the Act is not limited to farm animals. “Animal” is defined by Clause 2 of the Act as “an organism within the taxonomic group Metazoa, other than a human (or a human admixed embryo).” Thus, dogs and cats would also be covered by the Act to the extent that they might ultimately be precision-bred.
The territorial scope of the Act is England only.