A new approach to the use of precision genetic technology in plants and animals has recently been introduced in England. This will make is easier to use advanced DNA editing methods like CRISPR-Cas9 in the agrifood sector.
Application of genetic modification techniques have been constrained in Europe through rules applying to Genetically Modified Organisms (GMOs). These have been in place in the EU since the 1990s, with subsequent updates, and are seen to be one of the strictest regimes in the world. Organisms falling within this regime can only be released into the environment or placed on the market following an environmental risk assessment and public consultation. Registration of GMOs and labelling of GMO products is also compulsory.
The kinds of genetic modification that are considered subject to or outside of the regime are set out in the legislation, and mutagenesis is specifically excluded. However, a landmark CJEU ruling in 2018 (Confédération paysanne v Premier ministre) concluded that organisms generated using newly developed mutagenesis methods were within the scope of the code. The court said that the exclusion was aimed at conventional random mutagenesis methods, such as ionising radiation or exposure to mutagenic chemical agents, rather than modern approaches.
Overall, the EU framework is considered to be unduly restrictive by many, and to act as a brake on innovation in the agrifood sector.
The purpose of the UK’s Genetic Technology (Precision Breeding) Act 2023 is to reduce the regulatory burden and financial barriers in place for researchers and commercial breeders using precision breeding technologies. The intention is to take plants and animals produced using modern biotechnologies, and the food and feed derived from them, outside GMO regulation if those organisms could have occurred naturally or been produced by traditional methods. It replaces GMO controls with what are considered to be more proportionate and scientific measures.
The Genetic Technology Act will allow precision breeding of plants and animals subject to requirements to seek permission through rigorous risk assessment procedures and follow any requirements imposed. This might include following up on the health and welfare of genetically modified animals, for example.
Under this new system, an organism is considered to be “precision bred” if:
- any feature of the genome results from the application of modern biotechnology,
- every feature of the genome that results from the application of modern biotechnology is stable,
- every feature of the genome that results from the application of modern biotechnology could have resulted from traditional processes, whether or not in conjunction with selection techniques, alone, and
- the genome does not contain any feature that results from the application of any artificial modification technique other than modern biotechnology.
These concepts are developed further in the legislation, to explain for example, that “traditional processes” could include spontaneous mutation or in vitro fertilisation.
Two notification systems are planned – one for research and development and one for marketing purposes. A public register of precision bred organisms will be maintained.
The Act leaves much of the detail of the system to be fleshed out in regulations. Its effectiveness will depend on how well the systems and bodies operate once established by the Department for Environment, Food and Rural Affairs. However, this offers a welcome opportunity for the application of biotechnology in the agrifood sector, and marks a notable departure from the current EU approach.
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