Revamp of UK CRISPR regulation will require public trust


The UK government is consulting on changing how it regulates gene editing in food and agriculture.Credit: Jason Alden/Bloomberg/Getty

Thirty years ago, few would have dreamed of Nigel Halford’s wheat.

On 26 February, the plant biologist at Rothamsted Research in Harpenden, UK, and his colleagues unveiled a line of wheat plants that produce less of an amino acid, known as free asparagine, that can serve as the precursor for acrylamide. This is a chemical that has been linked to cancer and is formed when some foods are fried, baked or toasted1. So far, the wheat has not been tested in the field, but the hope is that flour made from it could be used to bake breads that produce less acrylamide than does conventional bread when toasted.

To create their low-asparagine wheat, the researchers used the genome-editing technology CRISPR to do something comparatively simple: they created small changes — often deleting a snippet of DNA — in the gene responsible for asparagine synthesis.

Did Halford and his colleagues modify the wheat genome? Technically, yes, because they changed the plant’s DNA. But should the wheat be called ‘genetically modified’, or ‘GM wheat’? The European Union thinks so, but many geneticists say that with the advent of tools such as CRISPR, gene editing should no longer be synonymous with GM.

Historically, definitions of GM technology in agriculture have referred to transgenics, the insertion of foreign genes into plant cells, often with no control over where those genes land in the genome. These are among the reasons why commercialization of GM technology is effectively banned in the EU. But many researchers say that most current applications of gene editing using CRISPR produce the kinds of change that could have been achieved by conventional breeding, just much more efficiently.

The UK government is broadly in agreement with this view. And now, because of Brexit, it has an opportunity to diverge from EU regulations. In a consultation that ends on 17 March, the UK government’s Department for Environment, Food and Rural Affairs (DEFRA) is proposing that gene-editing technology should not be regulated in the same way as GM, if it yields a result that could have been produced by conventional breeding.

The government’s aim is both to boost such research, and to accelerate the commercialization of gene-edited food and agricultural products. It is also asking for broader guidance on whether and how DEFRA should reform existing regulations governing organisms produced using genetic technologies.

In seeking to reclassify gene editing, the United Kingdom must also learn from its own past experiences. One reason why Europe has, so far, resisted commercializing gene technologies in food is because genetic technologies have evoked public concern around safety and environmental impact. At the very least, it means the UK government must avoid a narrative that the change is about cutting red tape or speeding up regulation — because that could suggest that safety and other concerns are not being taken seriously. Such a narrative could, in turn, impede research, development and evaluation of an important new technology.

Emerging trend

The United Kingdom is not alone in proposing to change its laws in this way. Other countries have been updating regulations to accommodate agricultural products created using genome-editing tools. Some, such as Argentina, Brazil and Japan, have developed a system in which gene-edited products are categorized on the basis of on how they were modified, and decisions are being made on a case-by-case basis. The United States also considers many gene-edited crops to be similar to conventionally developed crops.

Unlike commercial GM technology, which is dominated by large agribusinesses, CRISPR is proving to be popular with smaller producers, too. In the four years since Argentina amended its regulations, more than half of the submissions for approval of crops modified using what it calls “new breeding technologies” came from smaller companies and publicly funded laboratories2, although it remains to be seen whether that trend will hold as the technology matures.

In many ways, the EU’s stance on gene-edited crops, which stems from a ruling by the Court of Justice of the European Union in 2018, surprised researchers. Genome editing in its simplest and most commonly practised form allows researchers to make an alteration at a specific site in the genome. Many such changes can be found in nature, or could be produced using chemicals. Moreover, under existing EU regulations, although a researcher would need to declare the use of CRISPR technology, it is unclear how a regulator would distinguish genome edits from naturally occurring genetic changes. There is no mark, apart from the desired alteration, that indicates whether the change was natural or was made using technological means.

The EU’s continuing caution is in part because of public concerns around food safety, and the EU’s application of the precautionary principle. Indeed, such worries might also resurface in the United Kingdom, especially if the public is reluctant to draw a distinction between genetically modified and genome-edited crops. As genome-editing technology progresses, the edits will become more sophisticated — and could potentially create more consumer concern if they are simply rushed on to the market.

Independent evaluations

Before regulations are changed, the UK government should consider a number of actions.

First, it should consider commissioning independent evaluations of the safety and environmental impact of using CRISPR technology in agriculture and food. These could be farm-scale studies of gene-edited crops, similar to those that DEFRA’s predecessor department carried out in the late 1990s on GM crops3. The department then was not promoting new technologies, as DEFRA is now. To avoid any perceived conflict of interest, it would be better for such studies on gene editing to be commissioned by a separate body, such as the UK Food Standards Agency — which is linked to the Department of Health and Social Care — working with researchers from universities or independent research institutes. In addition, gene-edited foods could be regulated in a category called ‘novel foods’. Here, each application for commercial release would be assessed on its own merits by independent experts with appropriate expertise.

Taken together, such actions would help to reassure people that their concerns are being taken seriously, and that their safety is not being compromised (see The government must know it will not inspire public confidence if it is seen to be pushing a technology that has the potential to cause concern, without putting in place appropriate checks and balances.

If the United Kingdom does decide to change its regulatory approach to gene-edited crops, it should work constructively with the relevant EU authorities and share knowledge of its assessments, so that other countries and authorities can benefit from these insights. Low- and middle-income countries, for example, will be less able to research or commercialize gene-editing technology — as is the case with GM — unless the EU, one of the largest markets for their exports, similarly changes its approach.

The United Kingdom must consult thoroughly and globally, and researchers and regulators must dive deep into the urgent questions being asked. In addition to consumers, there are organic farmers who might have concerns about cross-pollination of their crops; there are concerns about animal welfare — whether, for example, the development of gene-edited, disease-resistant animals could lead to more agricultural intensification. At the same time, food producers need to be able to know whether or what kind of labelling will be needed; and UK exporters will need to know how any changes to UK regulations will affect trade with Europe and countries elsewhere.

The UK government has an opportunity to create a new system for regulating gene editing in food and agriculture that is scientifically sound. It must do so in a way that respects the independence of the regulatory process, because, among other things, that will be key to bringing the public with it.

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