A more permissive approach to gene editing regulation in Argentina has led to greater diversity of innovation and a shift in who brings products to market in that country, says one researcher.
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Argentina adheres to the Cartagena Protocol on Biosafety, which states that any living organism with a “new combination of genetic material obtained through the application of modern biotechnology,” is a genetically modified organism (GMO), according to a 2022 presentation from Argentina’s ministry of the economy.
If it doesn’t contain a new combination of genetic material — such as foreign DNA from a different species — it’s not a GMO and doesn’t have to go through an extra layer of regulation.
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Six gene-edited animals have gone through the regulatory process in Argentina, according to the International Service for the Acquisition of Agri-biotech Applications’ database. These include Nile tilapia, three different cattle applications, a polo horse, and a pig resistant to porcine reproductive and respiratory syndrome (PRRS).
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While resistance to biotic stress, such as disease, has been a key trait targeted by gene editing applications around the world, the potential for better yield is a primary concern for product hopefuls.
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Three gene-edited fish species are for sale to consumers in Japan. These were edited to reach market weight in half the time.
When it comes to regulation, Canada concerns itself with what is and isn’t a “novel food” — a food that doesn’t have a history of safe use as food. Novel foods must go through a safety assessment process.
Guidance from federal regulators, released in the last few years, has determined that gene-edited plant products won’t be considered novel as long as they don’t contain foreign DNA, introduce a new toxin or allergen, or change the food use of the plant.
The PRRS-resistant pig, however, is expected to be the first test of Canadian regulations on gene-edited animals.
The pig was approved by the U.S. Food and Drug Administration earlier this year, but … it won’t commercialize until it’s received approval in Canada, Mexico and Japan.
