In a break with the European Union’s stance, the United Kingdom plans to ease requirements for field research on gene-edited crops. But the UK government has stopped short of waving such products through to supermarket shelves, or changing the regulations on gene-edited livestock.
On 29 September, the country’s Department for Environment, Food and Rural Affairs (Defra) announced that by the end of the year, researchers who want to conduct field trials of gene-edited plants will no longer need to submit risk assessments. Researchers will still need to register their study plans with the department, however.
The decision will save thousands of pounds and days of work that were needed to meet the previous requirements for even a small field trial, says Wendy Harwood, a plant biologist at the John Innes Centre in Norwich, UK.
“We will now be able to test promising genome-edited plants in the field at the earliest opportunity, and to assess early on which plants show promise under real environmental conditions,” she says. “This is essential, as containment glasshouse conditions can never cover the full range of environmental conditions.”
Departure from Europe
The United Kingdom had previously followed the European Union’s policy, which regulates gene-edited agricultural products as rigorously as crops engineered using older, less precise genetic techniques.
Some researchers have argued that certain applications of gene editing deserve less scrutiny because they make small genetic changes that could, in theory, be found in nature, unlike with older techniques that sometimes involve inserting genes or DNA sequences from other species into plant and animal genomes. These older approaches rarely offer control over where in the genome these sequences will land. Gene editing, by contrast, allows researchers to make more targeted changes.
Following the United Kingdom’s departure from the European Union, Defra announced in March that it was considering a different approach, and launched a public consultation.
The 29 September decision does not address whether gene-edited crops will face a shorter path to market than their transgenic counterparts. The department plans to introduce legislative changes that alter the definition of genetically modified organisms to exclude gene-edited crops, and thereby ease requirements for commercialization, but has not specified a date for this.
And for the time being, UK research involving gene-edited animals will continue to be regulated as before, to ensure animal-welfare standards are met.
Any changes the United Kingdom makes will be watched carefully by countries that have yet to develop policies regarding gene editing. “It’s very, very important,” says plant biologist Caixia Gao at the Chinese Academy of Sciences’ Institute of Genetics and Developmental Biology in Beijing, where regulations on gene-edited food are still being formulated.
“A lot of countries look to what the UK and the United States do in regulating synthetic-biology technologies, and end up shaping their regulatory policies to be aligned or somewhat aligned with what the UK and US are doing,” says Jon Oatley, a reproductive biologist at Washington State University in Pullman.
Some countries, including Argentina, Australia, Japan and Brazil, have already determined how they will regulate gene-edited crops and livestock, and allow certain gene-edited products to run the regulatory gauntlet more swiftly.
Even so, gene-editing technology is young, and few crops have made it to market. The first commercialized gene-edited food product was a variety of soya bean that produces higher amounts of a compound called oleic acid. The crop is used to make a soya-bean oil that has a longer shelf life , launched in the United States by Calyxt of Roseville, Minnesota, in 2019. Earlier this year, a gene-edited tomato came on to the market in Japan boasting higher amounts of γ-aminobutyric acid (GABA), which the producers suggest could have health benefits.
More gene-edited crops on are the way. Bioheuris, a plant biotechnology company headquartered in Rosario, Argentina, launched five years ago and aims to develop herbicide-resistant soya bean and sorghum using gene editing. The country’s swift clarity around gene-edited products helped investors to feel more comfortable with the company’s approach, says co-founder and chief executive officer Lucas Lieber.
Gene editing could cut the cost of developing an engineered crop 100-fold compared to developing genetically modified plants with older techniques, says Lieber, partly because it is faster and partly because of reduced regulatory costs.
Bioheuris had earlier considered branching out into wheat and barley, but decided against it, says Lieber. “These crops are very important in Europe,” he says. “But Europe is not very friendly to gene editing, so we decided to concentrate on other crops.”
A swifter approval pathway for gene-edited crops in the United Kingdom might make his team rethink that decision, Lieber says.
But European policies could continue to have an impact on research. Plant biologist Yinong Yang at Pennsylvania State University in University Park says that although he might be able to carry out winter field trials of gene-edited rice in certain southern US states, some state farm associations are reluctant to approve the tests. “They have concern about that, because of the rice exports to the European Union,” he says. “If you mix some of the field-tested rice with export rice, that could create issues.”