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Health Canada modernizes plant breeding regulations

In new ruling, federal government confirms it considers gene edited crops to be just as safe as conventionally bred crops.
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The crop science sector has argued that gene editing is no riskier than conventional plant breeding.

WESTERN PRODUCER — Health Canada has finalized a decision that should pave the way for crop breeding innovation in Canada.

After years of reviewing the data and lengthy public consultations, on May 18 Health Canada clarified “when food products developed through plant breeding (will) require a mandatory pre-market assessment.”

Health Canada has decided that crops developed through gene editing are safe and, in most cases, will not require a pre-market safety assessment.

This will open up the very real possibility of dramatic improvements for small- and large-acre crops alike, from productivity improvements to new solutions for emerging pest pressures to advances in food and fuel crops that will benefit the entire value chain including consumers,” said Rick White, chair of the Canada Grains Council.

Gene editing is technology where scientists alter specific genes in a plant to achieve desired traits. Maybe a canola with enhanced resistance to certain disease. It’s different from previous transgenic technology because that involved inserting genes from outside organisms, usually bacteria. Some experts believe it could transform plant science and allow plant breeders to develop crop varieties more rapidly.

The crop science sector has argued that gene editing is no riskier than conventional plant breeding.

Health Canada agreed with that argument.

“Gene edited plants are just as safe as conventionally bred counterparts,” Health Canada representatives said in May 18 technical briefing.

By not requiring a pre-market assessment, crop science companies will not be required to conduct time-consuming experiments to prove that the crop is safe for humans and the environment. That can cost millions, years of delays and is a major obstacle for crop innovation.

Many researchers have been reluctant to work on products that might provide nutritional, environmental or production benefits due to unclear, costly, or time-consuming regulatory requirements,” the grains council said. “Health Canada’s new guidance gives plant breeders much more clarity about which innovations will trigger those processes, and confidence that their work will make it to farmers’ fields.”

Some plant breeding innovations will still require a pre-market assessment.

If a scientist uses gene editing to develop a new crop that includes foreign DNA, that will trigger a pre-market assessment.

As well, transgenic crops (using old genetically modified technology) will also require a pre-market assessment.

The Health Canada decision means Canada’s policy on gene-edited crops will be aligned with other countries, including the United States, Japan, Argentina and Australia. They have all concluded that gene-edited crops are safe and should be treated similar to conventionally bred crops.

Canada’s system, though, doesn’t focus on the how a crop or food was developed. Health Canada focuses on the final product.

“The new guidance will continue to use a product-based approach but will clarify Health Canada’s definition of a novel food,” the department said in a document explaining the plant breeding guidance.

“New GM foods that are not novel will not require a premarket assessment. This is not a change in approach, but rather provides clarity as to what is considered novel.”

Complex traits, like nitrogen-use efficiency or drought tolerance, may involve dozens of genes in a plant. Gene editing will be useful, but conventional breeding is exponentially more powerful than gene editing, said Richard Cuthbert, an Ag Canada wheat breeder in Swift Current, Sask.

Crossing two varieties may scramble the genetic code in an unexpected way and produce some magic, like a five percent boost in yield.

“You can take 120,000 genes (in wheat) and if you… could get them into every combination possible, there would be more combinations than there are atoms in the universe.”

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