In Canada, plant varieties with traits that are new to the environment and have the potential to impact human and environmental health are called “novel traits” and are regulated by the Canadian Food Inspection Agency.
They must be approved by the CFIA as well as Health Canada (in the case of food products) prior to commercialization or introduction into the environment.
That process can be lengthy.
Take the case of the Arctic apple, a non-browning variety developed by Okanagan Specialty Fruits, a small ag biotech company in Summerland, B.C.
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It didn’t use genome editing to develop the variety, but did employ a method of gene silencing called RNA interference. This technology was used to ‘turn off’ the genes that produce polyphenol oxidase, the enzyme that causes browning when an apple is bitten, sliced, or bruised.
Nevertheless, winning government approval proved to be an “extremely rigorous process,” company president Neal Carter said in an email. Okanagan Specialty Fruits submitted its application to the CFIA in December 2011 and it took until May 2015 before the apple was approved for commercial sale in Canada.
“Health Canada was also engaged for a review of Arctic apples to demonstrate they are just as safe as conventional apples,” said Carter.
While regulatory approval was lengthy — and came on top of a two-decade-long product development process — Carter said he understands why it took so long.
“We can only best speak to our own experiences with the regulatory processes which we’ve found to be extremely thorough and evidence based,” he said.
