Gene editing consultation: A new direction for the UK
In our earlier article, "Gene editing – UK government announces post-Brexit consultation", we set out the UK Government's plans to consult on the regulations surrounding the gene editing of crops and livestock and other genetic technologies.
That consultation has now closed and on 29 September 2021, the UK Government published the outcome of the consultation. We now summarise the Government's proposals and consider whether they give cause for concern.
The consultation outcome
The Government has unveiled new plans to reform regulation in this area in England; set to unlock new opportunities for farmers and others in the agri-innovation and agri-tech industries in the coming years.
The Government recognised that gene-editing and other genetic technologies "have great potential and can enable our farmers to grow plants that are stronger, more nutritious, more resilient to climate change and stresses, and less reliant on pesticides or fertilisers".
It also highlighted the potential benefits to key policy objectives; such as helping address food security and public health issues.
Genetic technologies were recognised as having the potential to support the Government's commitments in the 25 Year Environment Plan to protect the environment and help meet the Government's ambitions on Net Zero and "climate adaptation".
Initial plans set out by the Government focus mainly on revising the approach to how the UK governs the use of organisms developed using genetic technologies (such as gene editing), where the end product could have been produced by traditional breeding methods.
The current plans follow a "two-step approach".
- The first step focuses on easing some of the burdens, which currently apply to research and development for gene-edited plants. The present regulatory system will be maintained for animals and other organisms.
- The Government intends to use existing powers under the Environmental Protection Act 1990 to lay a statutory instrument by the end of 2021. The intention is to make research and development easier for plants that have been produced by genetic technologies, where the resulting genetic changes could have been developed using traditional breeding methods. The plans will remove the need for risk assessments and consents at the field trial stage.
- Researchers will still be required to notify Defra of research trials.
- Any commercial cultivation of the plants and any food products derived from them will still require authorisation in accordance with existing rules.
- The second step involves a review of the regulatory definitions of a genetically modified organism ("GMO") to exclude certain organisms produced by gene editing and other genetic technologies, if they could have been developed by traditional breeding.
- Consideration will also be given to measures required to enable gene edited products to be brought to market safely and responsibly; including traceability, labelling and consumer choice.
- Following this there will be a review of the approach to GMO regulations more broadly.
Despite the proposed changes to the regulatory framework surrounding gene-editing and other genetic technologies, it is intended that the existing novel foods and animal feed regulatory frameworks will remain in place.
The Government's intention is to adopt a "science-based approach" to regulation.
The plans set out by the Government mark a significant shift in the regulatory position from the current position, which is founded in EU law. It is nevertheless in line with developments internationally and perhaps even the attitude in the EU, where a review undertaken by the EU Commission in April 2021 concluded that current regulation of gene edited organisms is not fit for purpose.
Cause for concern?
Whilst the Government has unveiled what might seem like ground-breaking plans for reform, as discussed in our previous article, there still remains a degree of caution and scepticism around the idea of deregulation in this area.
In the consultation outcome, the Government seeks to address this by emphasising that it remains committed to the "very highest standards of environmental and food safety in the UK". There is no intention to weaken the strong food safety standards that the UK harnesses. The Government also seeks to provide reassurance that marketing of gene edited foods will only be permitted under strict conditions. It waits to be seen how this will play out in practice.
In any event, it is not expected that we will see gene-edited products, arising from any change in UK regulation, appearing on the shelves at our local Tesco any time soon. The consultation outcome suggests that it will be a number of years before this happens; during which time there will be further public engagement and research and appropriate precautions put in place.
Rather poetically, the consultation outcome notes that "genetic diversity is what gives life itself resilience". It remains to be seen how the regulatory landscape can be adapted to allow for this.