HomeArticlesThe Future Larger groundcherries. High-nutrient soybeans. Mushrooms that don't brown. Hornless cattle. These are existing examples of gene-edited crops and animals that, in some countries, are close to reaching supermarket shelves. Gene editing could revolutionise agriculture, but its progress will depend largely on how it is regulated. Gene Editing & Genetic Modification in Agriculture Making genetically modified organisms (GMOs) has long been a costly and stringently regulated process. Transgenic GMOs are created by transplanting desirable genes from one species into another, and there have long been concerns that this transfer of foreign genes might have unforeseen negative effects on the environment or consumers.1But, gene editing can alter genes in an organism’s genome without inserting any foreign DNA. And a new fast, accurate technique known as CRISPR-Cas9 was developed seven years ago to do just that. CRISPR-Cas9 - how does it work?Such mutations – changes to genetic code like deletions or alterations of genes – already occur in nature. For decades, farmers have selected crops and animals with desirable mutations to breed together. There is even the technique of ‘mutation breeding’, where crop plants are exposed to chemicals or radiation to try to generate beneficial mutations. Some 3,200 existing varieties of crops have been developed over 80 years using mutation breeding.2 But, are gene-edited organisms regulated at all?How Are Countries Regulating Gene Editing? Across different countries, attitudes to gene editing may resemble those applied to transgenic GMOs.European UnionIn Europe, only one GM crop (herbicide-resistant corn) has ever been approved for growing and is found in five member states.3 In 2018, the Court of Justice of the European Union decided to regulate gene-edited organisms like transgenic GMOs. The first person to eat a CRISPR-Cas9 edited plant was a Swedish researcher in 2016, but it’s unlikely any more Europeans will follow suit for a long time.4 United States of AmericaIn the USA, nearly all corn, cotton and soybeans are GM crops.5 And in 2018 the USDA announced it would not regulate gene-edited crops. A similar approach is taken by Brazil and Argentina, which are the following top global producers of GM crops. But in 2017, the FDA proposed it may regulate gene-edited animals similarly to drugs.Australia & Japan As of 2019, Australia also does not regulate gene editing, provided that the process inserts no DNA, and Japan has also declared gene-edited foods safe. ChinaChina has not yet taken an official stance but has over 20 labs dedicated to developing better crops using CRISPR-Cas9.6 Which Foods Are Gene-Edited? There are already two gene-edited products in the USA: Canola oil from herbicide-resistant plants was first available in 2019.7 Soybean is edited to be high in oleic acid, a healthier fat found in olive oil and avocados. The oil was first sold to Midwest restaurants in 2018.8 However, these crops were made using older gene-editing techniques. Upcoming crops that were edited with the new CRISPR-Cas9 method may include: ‘Waxy corn’, which contains higher levels of starch. It will first be used for label adhesive and to improve the consistency of food products. Non-browning lettuce that stays green for longer due to deleted genes for polyphenol oxidase (the enzyme which causes browning), giving it a longer shelf life. This could potentially save $3.3 billion of lettuce from being wasted each year.9 These could be just the tip of the iceberg. Oliver Peoples, CEO of Yield10 Bioscience, says a transgenic GM plant species can require up to $130 million per genetic change and take a decade to approve.10 That’s partly because of the sheer number of science studies and regulatory analyses that need to be done. What About Gene-Edited Animals? In the USA, there is one approved transgenic GMO animal (a fast-growing salmon), which took 20 years to approve and is still not available for sale.11 Some companies developing gene-edited organisms have deliberately moved to countries where regulation is lighter or non-existent. British genetics company Genus has modified DNA in pigs, which makes them resistant to Porcine Reproductive and Respiratory Syndrome, a disease that kills hundreds of thousands of piglets and sows each year. In 2019, they sold the license to a company in China.12Impact of Regulation on Gene-Edited FoodsLight regulation and more precise technology often allow faster development of gene-edited organisms compared to transgenic GMOs. For example, Intrexon’s non-browning lettuce moved from idea to commercial trials in just two years. In 2016, US company Recombinetics inserted a ‘hornless’ gene into the DNA of another cow breed to create livestock cattle without the physical inconvenience and injuries that horns can cause.13 This work was deliberately carried out in Brazil, where gene-editing is not regulated as heavily as genetic engineering of GMOs. Recombinetics disagreed that gene-edited organisms should be subject to the same amount of regulation as new drugs, as would happen in the USA. “It will kill the industry. It will restrict the industry to only the most wealthy companies,” said co-founder Scott Fahrenkrug to The Atlantic in 2017.14The company made the edited cattle’s genome publicly available online. But in 2019, the US FDA happened to identify bacterial DNA in the genome of the hornless cattle and some of their offspring.15 The bacterial DNA had been incorporated via the gene-editing technique the company had used. With 0.0000013% bacteria in their DNA, the hornless cattle were technically classified as GMOs - enough for the Brazilian government to cancel the project. It was a reminder that gene editing is still a new, expanding science - one that needs refinement but which also has the potential for unexpected results. Recombinetics says their gene editing method no longer uses bacterial DNA. It is still working in Brazil to develop a breed of heat-tolerant cattle and has plans to expand to Canada and Australia.16
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