The Draft Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022 would ease the regulatory process for the release, for non-marketing purposes (eg not for consumer sale or food), of genetically modified (GM) plants that could have been produced by “traditional breeding”. It is aimed at allowing scientific research on them to be carried out more easily. The regulations would only apply to England.
The regulations are a draft statutory instrument (SI) subject to the affirmative procedure. This means that both Houses of Parliament must pass a motion approving the instrument for it to become law.
The House of Lords is scheduled to debate its approval motion on 14 March 2022. However, Baroness Bennett of Manor Castle (Green) has tabled a motion for the House to decline approval. If the House declines to pass the regulations, they will not become law. At the time of writing, a date for approving the regulations had yet to be scheduled in the House of Commons.
What is the purpose of the regulations?
The regulations would remove the need to submit a risk assessment and to seek consent from the secretary of state before releasing into the environment GM plants (eg those subject to gene editing) that could have occurred naturally or by “traditional breeding methods”. However, the changes would only apply to GM plants being used for “non-marketing purposes”; for example, for the research and development of these plants, but not for food.
The regulations would instead require a notice to be given to the secretary of state containing certain prescribed information about these GM plants. This notice would have to be submitted to the Department for Environment, Food and Rural Affairs (Defra) before planting for onward growth or germination.
Explaining why the change is being proposed, the Government described the current system as placing a “disproportionate regulatory burden” on the research of these types of GM plants. It hopes the change will enable the “bioscience sector to further test the benefits and safety of the new products, without the burden of unnecessary regulatory processes”. In a press release to accompany the regulations, the Government explained how it hoped less regulation on the research and development of these GM plants could improve agriculture:
Harnessing the genetic resources that nature has provided through genetic technologies will create new opportunities for farmers to grow more resilient crops. This will support the development of new and innovative ways to protect the environment, such as significantly reducing, or eliminating the use of pesticides and herbicides—protecting pollinators. Another potential benefit includes making crops more resistant to adverse weather and climate change.
However, the Government stressed that the new rules would not mean environmental or research standards were lowered and that it would never compromise safety or welfare standards.
The Government has listed the proposed change as one of the benefits of Brexit and states that the policy would have contravened a 2018 EU court ruling. The case (C-528/16), which was held in the Court of Justice of the European Union, confirmed that in EU law all organisms produced by biotechnology are considered genetically modified organisms (GMOs) and would need to be regulated as such. In the explanatory memorandum for the regulations, the Government stated that it disagreed with this position:
The UK Government’s view is that where genetic alterations and combinations are of the type that are selected for in traditional breeding, the environmental release of these plants should not be regulated in the same way as the environmental release of GMOs. This is because it is the characteristics of the end-product that determines its risk to human health and the environment—not how they were made.
Further information on GM crops, including scientific comment and details on their regulation, can be found in the January 2022 Parliamentary Office of Science and Technology briefing ‘Genome-edited Food Crops’.
What has been said about the proposed changes?
The Government asked for feedback on the proposed changes set out in the regulations as part of a wider consultation on GMOs that ran in early 2021. The consultation received 6,440 responses from individuals, public sector bodies and other groups and institutions.
Summarising the responses to the potential changes to the regulation of gene edited plants, the Government found:
- “No new scientific evidence indicating that gene edited organisms should be regulated as GMOs”. It said some responses believed GMOs are “demonstrably different” to the products of gene editing (eg using and modifying genes already found in an organism) and that the advice from scientific experts (including the Advisory Committee on Releases to the Environment (ACRE) and the Royal Society) “likened the risks of gene edited organisms to those arising in organisms of the same or very similar species developed through traditional breeding methods”.
- The majority of public sector bodies (55%) and academic institutions (58%) did not agree with continuing to regulate products of gene editing as GMOs where the results could have been achieved through traditional breeding. However, most individuals (88%) and businesses (64%) wanted to continue to regulate the products of gene editing as GMOs. It found that non-governmental organisations (NGOs) were evenly split on the issue.
- The majority of academic institutions (63%) and public sector bodies (82%) believed there was a similar risk of harm to human health or the environment from gene editing compared with naturally bred counterparts. However, most individuals (87%) and businesses (64%) believed they posed a greater risk. Again, NGOs were fairly evenly split on this.
- Some respondents highlighted other concerns, including trade. They specifically mentioned possible difficulties exporting products to the EU or selling products in the UK. However, some believed the changes could result in trade benefits with other countries.
The full consultation response includes sections on trade and labelling of products, which give further details of the Government’s views on these matters. For example, regarding trade, it said it would “continue to monitor UK/EU trade implications for products developed using genetic technologies such as gene editing, maintaining our ongoing relationships with the EU institutions and working to mitigate any possible impacts where these arise”.
Lords Secondary Legislation Scrutiny Committee
The House of Lords Secondary Legislation Scrutiny Committee drew the regulations to the special attention of the House in its report published on 10 February 2022. It did so on the basis they are “politically or legally important and give rise to issues of public policy likely to be of interest to the House”.
The committee raised a number of concerns regarding the regulations, and quoted submissions received from bodies such as Beyond GM, GM Freeze and Organic Farmers and Growers. Concerns included:
- That there is no published guidance on the “scientific and regulatory criteria that will be used to determine whether a genetic change could have occurred naturally or through traditional breeding methods”. Defra informed the committee that ACRE were drafting guidance. However, at the time of writing, this has yet to be published. The committee suggested the House of Lords may wish to pursue this matter and urged the Government to publish the guidance in “good time” before the new rules take effect.
- Concerns over the new notification requirements, including that it requires “self-declaration” and that the prescribed information does not include the scale, scope or containment measures for releases. The committee reported fears that the releases could impact commercial crops or the wider environment. It said that Defra should consider conducting and publishing an evaluation of the practical application of the new rules and of any environmental or economic damage. Defra stressed that, as the gene editing had to be in line with what could be achieved by traditional breeding, they would not pose a greater risk to environment or health. It also said that researchers and developers may need to put measures in place to minimise contamination with other plants or food to abide by the stricter regulations about the marketing of GM plant material.
- As the new rules only applied to England, the committee had concerns about collaboration between researchers in different parts of the UK. Defra said it had communicated its plans to ministers in Scotland and Wales, but they did not want to make similar changes at this time. However, Defra did not believe this would cause any issues.
- Concerns from organisations, such as Beyond GM, that the Government’s consultation response and the regulations failed to represent the extent to which scientific opinion differed on the matter. Defra responded that it had considered all concerns as part of its policy development process.
- Whether the change should have been implemented by primary legislation, rather than secondary legislation. The committee believed there was a strong argument for this due to the interest in and concerns about GMOs.
The committee also regretted that the explanatory memorandum did not expand on the Government’s plans for wider reform in this area (which is referred to in the impact assessment for the regulations). Commenting on the Government’s plans, and defending their decision to introduce these changes through regulations, Defra said they were taking a “cautious step-by-step approach”. It continued:
We want to make changes carefully. Research scientists will continue to be required to notify Defra of these plant research trials. The commercial cultivation of these plants, and any food products derived from them, will still need to be authorised in accordance with existing GMO rules.
Our next step will be to review the regulatory definitions of a GMO to exclude organisms produced by gene editing and other genetic technologies if they could have been developed by traditional breeding. We will also consider the appropriate measures needed to enable gene edited products to be brought to market. This will be followed by a review of our approach to GMO regulation more broadly.
Commons Delegated Legislation Committee
Daniel Zeichner, the Shadow Minister for Food, Farming and Fisheries, indicated that Labour had some concerns about the regulations during the House of Commons Delegated Legislation Committee proceedings. However, he said that Labour would not oppose the regulations. He stated that although the SI could be seen as a ‘small step’ towards change, the Government still needed to be clearer on the wider details to improve confidence among the public and business:
We are not going to oppose this SI, but we are not satisfied that the Government have yet set out the clear and strong regulatory framework that is needed to provide the certainty that investors need, the reassurance that the public need, or the protection that the environment needs. All those things are important, but they are also interrelated, because investor confidence does not come without public confidence […]
It is important to be clear that this SI is about research, not products that reach consumers. However, I am afraid that the failure to provide the necessary structures and reassurances could turn a small step into a much bigger mistake if it fails to provide the necessary public reassurance.
The Minister for Agri-Innovation and Climate Adaptation, Jo Churchill, said that the regulations were a “cautious first step” in the Government’s new approach to gene editing, but that further changes would involve the use of “primary powers”. Ms Churchill said that more information on the Government’s plans would come out in the next Queen’s Speech. She also emphasised the Government’s stance that gene editing could “help us to grow crops that are more nutritious, beneficial to the environment and resistant to climate change, disease and pests”, and stressed the importance of supporting our “international reputation of scientific excellence in genetics”.
The proposed changes have been broadly welcomed by the National Farmers’ Union. Commenting at the time of the Government consultation, the NFU vice president, Tom Bradshaw, believed that “new precision breeding techniques, such as gene editing, could protect crops and animals from pests and disease, help deliver net zero and allow farmers to produce more home-grown food”. However, he did mention the importance of analysing the implications for trade with the EU and promoting confidence among the public:
It is vital that the UK is still able to trade with the EU and that the internal UK market remains functional should England take a different approach to regulating new precision breeding techniques. Government must analyse the implications and discuss the issues in detail with its counterparts in other countries as well as with all parts of the UK supply chain, as a matter of urgency. Above all, it must take responsibility for the policy and communication needed to inform the public to give them confidence in the proposed regulation.
The changes are also generally supported by the science sector. For example, Professor Martin Warren, head of the food innovation and health programme at the Quadram Institute, said:
Gene editing provides the opportunity to enhance the nutritional quality of plants—a really important issue as we embrace more plant-rich diets. Gene editing represents a very precise way to improve specific qualities such as the accumulation of higher levels of micronutrients, including minerals and vitamins, which are often found in low abundance in crops.
The [policy] announcement is welcomed as it will allow the faster development of such plants, which can be used to tackle key national and global challenges associated with malnutrition.
However, the campaign group Beyond GM is highly critical of the regulations. Its director, Pat Thomas, welcomed the concerns raised by the House of Lords Secondary Legislation Scrutiny Committee, believing the regulations lack clarity and do not represent the views of the public. Thomas urged Parliament to reject the regulations and for Defra to engage further with a “broader group of stakeholders” to consider how best to approach the issue of genetic technologies in agriculture.
- Department for Environment, Food and Rural Affairs, ‘Blog: New legislation reduces time and cost of gene editing trials for researchers’, 21 January 2022
- Adam Vaughan, ‘Gene-edited food is five years away in England, says government scientist’, New Scientist, 20 January 2022
- GM Freeze, ‘Gene editing consultation’, accessed 4 March 2022