To modify or not to modify? Genetic Modification and Gene Editing – A divergence by the UK – Lexology

Against the backdrop of the cost-of-living crisis it is argued that the UK could bolster food security, combat climate change and lower food prices by relaxing the rules on and around genetic engineering. By designing more resistant crops which are less reliant on fertiliser and are more nutritious, progress could be made. On the other hand, this may be a short-sighted approach to deregulation and taking the risk could result in disastrous consequences.

The Genetic Technology (Precision Breeding) Bill 2022

The arguments are surfacing as The Genetic Technology (Precision Breeding) Bill (GT (PB) Bill) which is currently in the House of Commons at the report stage (allowing the House to consider further amendments) heading for its 3rd reading. Much of the debate centres around the understanding of the technology.

Genetically Modified Organisms (GMOs) are organisms in which the genetic material (DNA or RNA) has been altered in a way that does not occur naturally, and the modification can be replicated and/or transferred to other cells or organisms. This typically involves the removal of DNA, manipulation outside the cell and reinsertion into the same or other organism. Gene editing (GE) is arguably different as rather than inserting new DNA it edits the organisms own DNA - which could happen over time, but this essentially speeds up the natural process. Both plants and animals can be genetically manipulated.

Regulation (EC) No 1829/2003 provides the general framework for regulating genetically modified (GM) food in the EU with a centralised procedure for applications to place GM food on the EU market. It focusses on the traceability and labelling of GMO and the traceability of food and feed products to ensure a high level of protection of human life and health. GM foods can only be placed on the market after scientific risk assessment of the risks to human health and the environment.

The EU implemented these regulations back in 2001 which heavily restricted the use of GMOs and it has maintained that conservative position since. To continue not to allow GMOs is at odds with other countries, such as Australia, Japan and the US. As the technology developed several member states (including the UK) felt that a more relaxed approach to genetic editing would be beneficial. However, in 2018 the European Court of Justice in, Confederation Paysanne v Premier Minister (C-528/16) decided that there was no real distinction with gene editing (also described as Precision breeding) and they were to be treated as GMOs within the meaning of the GMO Release Directive 2001.

Nevertheless, in the UK in 2019 the then prime minister famously declared that he would liberate the U.K.s extraordinary bio science sector from anti-genetic modification rules. Consequently, since leaving the EU the UK has been working on moving away from the EUs stricter definition of a GMO as evidenced by the GT (PB) Bill.

The Bill defines precision bred to be, if any, or every feature of its genome results from the application of modern biotechnology and every feature of its genome could have resulted from either traditional processes or natural transformation.[1]

It is argued that this removes unnecessary barriers to innovation inherited from the EU to allow the development and marketing of precision bred plants and animals, which will drive economic growth and position the UK as a leading country in which to invest in agri-food research and innovation.

The main elements of the Genetic Technology (Precision Breeding) Bill are:

Creating a new, simpler regulatory regime for precision bred plants and animals that have genetic changes that could have arisen through traditional breeding or natural processes. No changes are proposed to the regulation of animals until animal welfare is safeguarded.

Introducing two notification systems for research and marketing purposes where breeders and researchers will need to notify Department for Environment, food and Rural Affairs (Defra) of precision bred organisms. The information collected on precision bred organisms will be published on a public register.

Establishing a new science-based authorisation process for food and feed products developed using precision bred organisms.

This is the result of an All-Party Parliamentary Group which called for amendments to be made in 2020 to the, at the time, forthcoming Agriculture Bill 2019-21 (now the Agriculture Act 2020) to allow precision breeding in the UK.

The amendments would require changes to the UK Environmental Protection Act 1990, including changing the use of the EU definition of a GMO which would allow UK scientists, farmers and both plant and animal breeders access to gene editing technologies that other countries outside the EU have.

The focus in the UK is to allow traditional breeding methods to alleviate some of the effects such as extreme weather, food shortages, the cost-of-living crisis and to encourage pest-resistance.

The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022

On 11th April 2022, the Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022 implemented an alignment of GE with the regulation of plants using traditional breeding methods. The Regulations removed the need to submit a risk assessment and seek consent from the Secretary of State before releasing certain GE plants for non-marketing purposes. They apply to England only.

This will allow for the release and marketing of gene edited products under certain circumstances that has so far been prohibited by the EU. It will allow UK scientists to develop plant varieties and animals with beneficial traits that could also occur through traditional breeding and natural processes, while providing safeguards in both marketing and authorisations via regulation.

Taking a Risk?

Another consequence of leaving the EU is that the Food Standards authority (FSA) is now responsible for authorising Novel foods applications in the UK. The FSA points to this need for authorisation as a further check and balance on any risks that may arise from a divergence from EU regulation.

Although it is argued that the Bill may have been drafted a little hastily, any food developed using new technology is subject to the scientific scrutiny of a Novel foods application. If there is a risk of unintended consequences from GE (it is argued that there is a risk of unidentified and untested mutations resulting from gene editing) the role of regulatory authorities such as DEFRA and the FSA is to ensure that no unintended product gains approval.

The debate is becoming increasingly focussed as the cost-of-living crises deepens.

Co-Authored by Laura Hipwell, Trainee Solicitor at CMS.

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To modify or not to modify? Genetic Modification and Gene Editing - A divergence by the UK - Lexology