GMO Regulation in the UK - A new beginning.
Updated: May 24, 2022
Welcome to the Foodtech Compliance regulatory round-up of the UK food-tech sector.
Each week, we will publish articles by experts on the current regulatory environment in the UK food-tech sector.
In this first instalment of our overview we have barrister Josh Normanton - from leading London Chambers 5 Paper Buildings - giving us his update on the developments in relation to Gene Edited Crop Research Trials in the UK:
The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022 (The Regulations) come into force in the UK this week with little fanfare. Given their dull title, the Regulations may not immediately capture the imagination. Yet they reflect a remarkably progressive development in the regulation of field trials concerning genome-edited crops, which makes it both easier and cheaper for plant scientists to conduct such trials. This is a crucial first step in unlocking significant and much-needed change in the United Kingdom’s approach to the genetically modified (GM) food industry.
Historically, GM crops have not been well regarded in the UK. Vilified as “Frankenstein Foods” by both the British press and (notably) Prince Charles, public opinion has been firmly against GM Foods for some time now. However, in many different jurisdictions, GM foods are a recognised and essential component in plans for global food sustainability as well as part of a powerful response to issues such as climate change and biodiversity. Building on the aims of the government’s consultation response, the Regulations appear to represent a dawning and realistic acceptance by the UK government as to what the future of a sustainable food industry will comprise. With rising food prices and ever-increasing energy costs, is it now time for the UK to wholeheartedly embrace this technology which is already well established in North and South America?
Background
In very general terms, Genetically Modified Organisms are organisms in which the genetic material (DNA or RNA) is altered, via human scientific manipulation, and then reinserted. The modification will then replicate itself to other cells within the organism. The aim is to improve certain characteristics of the organism. In plants, this technique can be used to produce pest-resistant crops or crops that can withstand extreme weather (i.e., combat prevalent and current problems faced by the food industry).
According to The Royal Society, GM crops are grown in well over 10% of the world’s arable land. The USA, Brazil and Argentina are the leading producers. USA, Brazil and Argentina are the leading producers. However, despite the seeming benefits, there are no GM crops being grown commercially in the UK. This cautious approach stems from the UK’s membership of the European Union and the legislative framework within which it has be forced to operate. The EU uses the 'Precautionary Principle', demanding a pre-market authorisation for any GM Food to enter the market. The EU treats all GM crops, as being ‘Novel’, thus requiring extensive, science-based evaluation by the European Food Safety Authority (EFSA) before approval is granted.
In January 2021, the Department for Environment, Food and Rural Affairs (Defra) consulted on the regulation of genetic technologies in the UK. The consultation had two clear aims:
A review of the current regulation of gene edited organisms which possessed genetic changes that could have been introduced by traditional breeding, and;
A review of how the wider regulatory framework governing GMOs could be reformed.
The consultation was a clear signal that the UK government, following its exit from the EU, was now seeking to unlock the potential of GE technologies which were previous subject to the European Commission’s precautionary principle. As stated in the consultation:
“Green growth can help new markets that support a sustainable economy and enable UK businesses to compete globally.”
In the consultation, the UK government indicated its intention to depart from the key European decision of Confederation paysanne v Premier minister (C-528/16). In this case, the European Court of Justice (ECJ) confirmed that all GE organisms are classified as GMOs regardless of whether they could be produced by traditional breeding methods. This was an overly risk adverse position which choked the development of the market despite the scientific evidence. In effect, the ECJ considered that there was sufficient risk around GE organisms to warrant stringent regulation, even if modifications could have been achieved by traditional breeding methods.
The UK government disagreed with this analysis. Describing its position as “following the science”, it expressed a will to align with the approach taken in a number of other jurisdictions, including Australia and Argentina. Those jurisdictions consider the risks to be entirely manageable.
In September 2021, Defra published its response to the consultation, confirming that the government would:
Put secondary legislation before Parliament by the end of 2021 to align the regulation of research and development on gene editing of plants with that applying to plants developed using traditional breeding methods. For the reasons set out above, this represents a divergence in the UK’s approach to regulation of GMO.
Consider issues relating to the gene editing of animals. There was however an acceptance that changes in this field would take far longer due to animal welfare considerations.
The Regulations
In short, the Regulations change the submission requirements from that of an approval process to a simple registration notification. Where genetic alterations are of the type that are achievable in traditional breeding, then the government considers there to be no additional risk involved. Sensibly, it is the characteristics of the end-product which will determine its risk to human health and the environment, rather than how the product is produced.
The UK government has done away with the disproportionate regulatory burdens conferred by the previous regime on the research of the GM plants which could have been produced by traditional breeding methods. The difference between the old and regime is stark. The soon to be defunct position requires that: (a) each GM submission must be assessed on a case-by-case basis; and (b) a full safety analysis must be carried out before approval (involving a risk assessment, a public consultation, and publication of details of the research trial. In contrast to that extremely lengthy and expensive process which has no guarantee of a successful outcome, applicants wishing to trial a qualifying GM plant must now simply submit a notice to the secretary of state. The notice must be submitted to Defra in advance of the trial commencing and details of the notice will be published on the public register. Permission is no longer required. For those interested in the practical aspects of the notification process, detailed guidance has been issued confirming what information must be provided in the notice.
Conclusion
That field trial research of the gene edited crops will be permitted without requiring risk assessments and consent from the Secretary of State is an extremely positive and exciting step. By providing a less onerous route to trial approval, these new regulations will increase the prospect of genetically modified foods being grown and sold in the UK. They should speed up the delivery of potential health and environmental benefits to consumers. More generally, the government’s approach places the UK at the forefront of the development of a market solution to a range of fundamental problems facing humanity.
However, there is still much further to go. The commercial cultivation of these plants and any food or animal feed products derived from them will still need to be authorised in accordance with existing genetically modified organism (GMO) rules. The themes present in the government documents referred to above indicate the government is heading in the right direction, but momentum cannot be lost.
Please note: Regulation of GMOs is a devolved matter and these new changes only apply to England. Defra has advised it will continue to work with the devolved administrations of Scotland, Wales and Northern Ireland to progress future policy changes.
Josh Normanton
5 Paper Buildings
14th April 2022