Health Canada defines and clears path forward for gene-edited crops

Date:05-25-2022

Health Canada has issued a long-awaited clarification on how it will regulate different forms of plant breeding, including newer gene-editing methods.

Genetically modified crops are deemed “novel” under Canada’s regulatory framework, requiring an expensive multi-year safety review before being approved for sale, but there was uncertainty about whether gene-edited crops would also be treated as novel, since gene editing doesn’t typically involve the introduction of genes from other organisms.

After holding public consultations in the spring of 2021, Health Canada published new policy on May 18, 2022 that says gene-edited crops that meet certain conditions can be treated like conventional-bred crops, and not require a pre-market safety assessment.

“It’s great news in the sense that there was a lot of ambiguity and plant breeders never knew what was going to trigger a full safety review,” says Pierre Petelle, president and CEO of CropLife Canada. “Sometimes innovations were put on a shelf because they didn’t want to risk triggering a review and all the data requirements, and this is a great development.”

Given the lower cost and increased precision of gene editing relative to older genetic modification methods, the regulatory certainty should lead to new investment in plant breeding in Canada, he says.

“Whether it’s small, public or private breeders, or large companies, now we’ve got predictability, we can really push Canada as a place to invest and to bring those technologies for Canadian farmers,” says Petelle. “What it means for farmers is potentially many, many more choices coming down the road, and innovative products, niche products for a variety of different crops.”

While investment in genetically modified traits was historically confined to corn, soybeans, and canola, Petelle says gene editing has potential to unlock value across all crops — from cereals, oilseeds, and pulses to fruits and vegetables.

There are still some cases where gene-edited crops would have to undergo a pre-market safety review — for example, if the process results in the presence of foreign DNA in the final product or in an elevated level of an allergen or toxin relevant to human health.

Health Canada has also announced the launch of a voluntary transparency initiative that it says “provides plant breeders the opportunity to inform Canadians about what gene edited plant products will enter the Canadian marketplace,” with the goal of enhancing public trust in gene-edited products and the regulatory system.

The National Farmers Union, meanwhile, is criticizing the new policy alongside several activist organizations that have traditionally opposed genetically modified crops. The groups say they are “alarmed that the federal government will now allow product developers to assess the safety of many new gene-edited foods with no role for Health Canada regulators.”