Canada came a step closer to paving the way for gene edited food products this year when it moved to transform its novel food regulations.
Early in the year, Health Canada launched a 60-day public consultation in regard to Canada’s novel food regulations. The public consultations surround two proposed “guidance pieces” focused on plant breeding:
- Proposed Changes to Health Canada Guidance on the interpretation of Division 28 of Part B of the Food and Drug Regulations (the Novel Food Regulations): When is a food that was derived from a plant developed through breeding a “novel food”?
- Proposed Health Canada Guidance on the pre-market assessment of foods derived from “Retransformants” under Division 28 of Part B of the Food and Drug Regulations (the Novel Food Regulations).
Health Canada says its intent is to ensure the guidance:
- provides greater clarity, predictability and transparency regarding the regulation of novel foods derived from plants, including those developed using gene editing technologies
- provides an efficient and predictable pathway to commercialization for new products
The changes could allow plant breeders to make the most of gene editing technologies.
It was a long time coming, bringing much-needed clarification that will help plant breeders to better innovate.
Krista Thomas, vice-president trade policy — seed innovation with the Canada Grains Council, says the consultations were welcome news after several years of informal talks between industry and government.
“For a long time, we’ve been asking the Government of Canada to clarify the regulatory environment for gene editing to make sure that Canada can stay on a level playing field with our trading partners and that our farmers can have access to innovation,” she says.
“We need this clarity in place so that the latest cutting-edge breeding techniques could be introduced successfully in Canada. We all hoped it that that would happen as quickly as possible. We’re really glad to see that things are moving in a good direction now.”
The regulatory system developed in Canada in the early 1990s was meant to regulate genetically modified (GM) products (plants, food and feed) that have novel traits (PNTs). PNT varieties are approved if a risk assessment concludes the risk from a PNT, or the food/feed from it, is substantially equivalent in terms of its use and safety to an unmodified counterpart. The need for an assessment is based on the final product, not the process used to create the product.
“Most of the rest of the world has a more process-based trigger for pre-market oversight. In Canada, we’ve always had a product-based approach. It’s not supposed to matter what method you use to develop the product, it’s the final characteristics of the product itself that determine whether it’s a PNT,” says Jennifer Hubert, plant biotechnology director for CropLife Canada.
“While that is indeed a more science-based approach to oversight, it comes with its own challenges.”
The result, she says, is ambiguity around when a product is “novel” and what characteristics make it so.
The new regulations will serve to solve that problem.
—This story is the seventh instalment in our Top 10 Stories of 2021. For more on this topic see the links below:
How Canada’s Novel Food Regs can Pave the Way for Innovation
When is a Novel Food Novel? That Question is Finally Being Answered
