In our previous article Gene Editing Consultation: UK Government announces plans to relax the rules and regulations surrounding gene-edited crops, we set out the government’s plans for reforming the regulatory landscape for gene editing.
The government has now progressed those plans with the introduction on 25 May 2022 of the new Genetic Technology (Precision Breeding) Bill 2022-2023.
The new Bill makes provision about the release and marketing of, and risk assessments relating to, precision bred plants and animals – and also the marketing of food and feed produced from such plants and animals and for connected purposes. The Bill aims to move away from legal interpretation governing this area and to give more power to science.
Once enacted, the Bill shall enable research in gene editing (GE) which (together with genetic modification), was previously prohibited in the UK under EU law. It will give farmers and producers greater power to develop plant varieties and animals with beneficial traits (which can be produced through more traditional methods) but in a more efficient and potentially environmentally friendly way.
The Bill is split into 5 parts:
In broadest summary, the Bill applies to “precision bred organisms” (PBO) (i.e. gene edited organisms). That is defined in section 1 of the Bill as any organism if any feature of its genome results from the application of modern biotechnology, if such feature is stable and if every feature of its genome could have resulted from:
Readers should refer our earlier article (Gene editing – UK government announces post-Brexit consultation | Michelmores) for more information on what GE is.
The Bill then makes provisions to enable the release and marketing of PBOs in England (see sections 3 to 5). Certain steps must be taken in order to do so, which includes certain notification requirements. The Bill includes added safeguards, such as the ability to refer matters to relevant advisory committees/bodies and also the requirement for welfare declarations and risk assessments for certain animals (as defined). The Bill also requires certain registers to be kept by the Secretary of State.
Provision is then made in the Bill for regulations to be made for regulating the placing on the market in England of food and feed produced from PBOs (see Part 3 of the Bill). The wording of Part 3 sets out matters, that such regulation might address (e.g. requirements for prior authorisations from the Secretary of State and requirements for traceability) – all aimed at safeguarding products released into the market for consumption by humans and other organisms.
The Bill further sets out enforcement powers for breaches of certain obligations which largely comprise the ability to issue compliance notices, stop notices and monetary penalty notices (see Part 4).
In large, the legislation is intended to apply to England (and Wales) only with a small number of exceptions (see section 47). The Bill predominantly addresses GE of plants.
The Bill follows earlier relaxation of the rules in respect of gene-edited plants under the Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022.
The full text of the Bill is on the UK Parliament website. It is at the very early stages of its passage through Parliament. Following the first and second readings, it is currently at the committee stage in the House of Commons, but there will doubtless be much debate on, and amendment to, its text, both in the Commons and in the Lords.
The Bill, nevertheless, represents a significant milestone in the UK in its move away from the GE prohibitions, that have long existed in EU law. The Bill seeks to facilitate GE with certain safeguards in place. There are powers for further regulations to be made to increase control and safeguarding in this area, so it waits to be seen what further regulations are indeed introduced.
These developments have been hailed by some as removing unnecessary barriers to research into new gene editing technology, which for a long time have hindered the UK’s agricultural development and world leading agricultural research institutions. It is considered a key step in bolstering the UK’s food security – especially in the wake of the Ukraine conflict. There are ambitions to produce higher yields from land, improve food quality and reduce wastage. Biodiversity benefits are also noted.
Defra itself has hailed the benefits GE could bring – including (according to Defra): more efficient and precise breeding; production of crops with fewer inputs (e.g. pesticides and fertilisers); improving sustainability, resilience and productivity; boosting climate change resilience; creating safer food (by e.g. removing allergens); and creating plant varieties and animals, which have improved resistance to diseases (reducing reliance on products such as antibiotics).
Others (such as the Landworker’s Alliance), consider the changes to be unnecessary; noting that there are existing methods to address these matters – or that the focus should be on developing more natural methods. There are also currently deep concerns about the lack of requirements around labelling of products which contain PBOs – albeit those may be addressed in further regulations. Others (including the RSPCA) continue to have concerns regarding animal welfare and ethics.
As has been shown in the media, the Scottish government has also pushed back strongly on the application of any part of the new legislation to Scotland. It therefore remains to be seen what bearing the Bill will have on the Scottish position; no doubt this will be addressed in any further revisions of the Bill.
There are then others who still take the view that the Bill remains overly prescriptive with too many hurdles to overcome, which may prevent investment and innovation in this area.
Clearly, there remain split views within the industry as to the benefit and appropriateness of the proposed Bill. We will see how the Bill progresses through Parliament and what changes are made to the initial draft. Come what may, the success of the GE industry and the GE market will doubtless be driven by consumer attitudes towards GE – irrespective of the details of the legislation.
For more information, please contact Seema Nanua.