New Act opens doors for modern biotechnology in England
The Genetic Technologies (Precision Breeding) Act was passed into law in England in March 2023, ten months after it was introduced to Parliament. The Act enables the development and marketing of gene-edited crops and animals in England, allowing us to grow more resilient crops and breed animals that are more resistant to harmful diseases and put those to market. In this blog, Linda Bedenik, BIA's Policy and Public Affairs Manager looks at the changes the new Act brings and what it means for modern biotechnology.
Gene editing is a relatively new addition to the biotechnology toolbox that allows the DNA of an organism to be precisely edited, fast-tracking a process that has been taking place naturally and through traditional breeding techniques for millennia. It will enable us to make more efficient changes than those achieved by traditional breeding methods in order to tease out beneficial traits in plants, such as tomatoes producing Vitamin D and shorten the time it takes to bring such new innovations to market.
Gene editing holds the potential to help society tackle many challenges perhaps most immediately, through improving food security by developing crops that are resistant to blight. As such, gene editing is a vital tool in transitioning to a sustainable food supply and bioeconomy. The Genetic Technologies (Precision Breeding) Act moves the UK one step closer to realising this potential.
What does the new Act do?
The new Act enables the development and marketing of ‘precision-bred plants and animals', which are developed through ‘modern biotechnologies’ such as gene editing, allowing the use of the latter to develop and market the former. It covers several genetic techniques that can be applied to make precisely targeted changes that produce desired traits which could have occurred naturally or through traditional breeding processes. While traditional breeding and naturally occurring processes of genetic changes in plants and animals are lengthy, gene editing techniques allow us to accelerate these natural processes.
- Remove plants and animals, produced through precision breeding technologies, from regulatory requirements applicable in England 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 derived from using precision-bred plants and animals.
This means that plants and animals produced using genetic technologies will no longer be regulated as Genetically Modified Organisms (GMOs) if they could have been produced by traditional breeding methods. The regulation of GMOs, derived from EU law, is more than two decades old and has not kept pace with scientific developments in genetic technologies, imposing strict rules on those precision-bred organisms that pose no greater risk than their traditionally bred counterparts. Genetically modified organisms, where modern techniques are used to insert DNA from another species, continue to be regulated under the EU GMO regulation.
Gene editing techniques on plants and crops have already been used in the UK for many years for the purposes of research. The UK has built a strong knowledge and research base using these techniques, such as at the John Innes Centre in Norwich and the Sainsbury’s Laboratory in Cambridge. The Act allows years of research to bear fruit and be applied to develop crops and foods that are more nutritious, resistant to climate change and better for the environment and human health.
Countries with science-led gene editing regulations, such as the US, have been capturing the economic benefits of this growing industry for many years. For example, the US engineering biology sector, which largely consists of companies working with and developing new gene editing technologies (and GMOs), raised nearly $8 billion USD in equity investment in 2020. With its new Act, England joins countries such as Argentina, the US, Australia and Japan which have similar legislations, with the EU potentially following suit soon.
The new Act safeguards England as a place where science and technology can be developed to the benefit of the global population, and makes it an attractive destination for investment, for top talent to conduct research, and for innovative companies to start and grow.
It enables the use of genetic technologies in plants first, followed by animals later whilst considerations continue over safeguarding animal welfare. A new regulatory framework will be phased in step by step to ensure animal welfare standards are met and to provide a clear and safe route to market. The Food Standards Agency will consult on new food and feed legislation this year and produce a new proportionate risk assessment for precision-bred food and feed.
The BIA has been supportive of a pro-science and innovation-friendly regulatory framework for gene editing following the UK’s departure from the EU and diverging from the EU in regulating gene-edited products as genetically modified organisms.
Although the Act does not pertain to human medicines, the approach taken in it can have implications for future regulatory changes for medicines and human health, an important point BIA raised in our 2021 submission. Together with the study of genomics, gene editing enables truly personalised medicines, designed to effectively address a patient’s conditions with as few side effects as possible. It is also paving the way for more accurate, convenient diagnostic products that help characterise and potentially prevent disease, by picking up signs much earlier.
The Act is opening the door to expand the use of gene editing to the benefit of human health and may pave the way for GMOs later on. It enables modern biotechnologies to be a key driver in building a sustainable and healthy environment and economy, an area the BIA is expanding into.