A recent Health Canada decision deemed gene-edited plants safe for the Canadian food supply — and the decision wasn’t without controversy.
This spring, Health Canada ruled on new guidance for its Novel Food Regulations, after lengthy consultations.
Why it matters: Removing gene-edited plants from the more highly regulated class of “novel foods,” under a set of circumstances will make Canadian agriculture more flexible, adaptable and better able to weather climate change — according to the decision’s champions. Opponents say it’s a dereliction of Health Canada’s responsibility.
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A “novel food” is either a substance that doesn’t have a history of safe use as food, a food that has gone through a process not previously used for that food or which causes the food to undergo a major change, or a food that comes from a plant, animal or micro-organism that has been genetically modified to show (or not show) characteristics it didn’t before, or to have one or more characteristic that no longer falls within the expected range, according to the federal government’s website.
“Genetically modified,” here, includes traditional breeding, genetic engineering, gene editing and mutagenesis.
Before a “novel food” can go to market, its manufacturer or developer must prove to Health Canada that it’s safe.
Under the decision made this spring, gene-edited plants won’t be considered novel — provided the final plant product doesn’t contain foreign DNA. Similarly, the gene editing can’t have introduced or increased a known allergen or toxin of impacted key nutritional composition, and it can’t have changed the food use of the plant.
For example, pod shatter resistance is a trait that’s already commercialized in Canada, said Logan Skori, CEO and co-founder of biotechnology company AgGene Inc. If researchers could develop pod shatter resistance via gene editing, that variety probably wouldn’t need extra safety checks.
Proponents called Health Canada’s ruling appropriate, evidence based, and an open door for innovation.
“In my opinion, this regulatory decision will benefit all Canadians,” wrote Stuart Smyth on the blog SAIFood.
Smyth is the Agri-Food Innovation and Sustainability Enhancement Chair at the University of Saskatchewan.
“As climates (sic) change continues, plant breeders will be able to get new crops, fruits, and vegetable varieties commercialized more rapidly,” Smyth wrote. “Having crops and food crops that can sustain yields as climates change is crucial to ensure that Canadian food security doesn’t decrease.”
Farmers are also under increased pressure from plant pathogens and disease, Agriculture and Agri-Food Canada (AAFC) researcher Andriy Bilichak said.
“It’s a constant race between pathogen and breeders developing new varieties,” he said.
Food scientists can also explore new traits for consumers, Smyth added, citing examples like improved nutrition and freshness.
Smyth wrote that with a lengthy history of risk assessments and crop regulation under their belts, Canadian regulatory scientists understand the science behind “innovative plant breeding.”
This knowledge “ensures that Canada has effective regulations that certify that food products are safe for Canadians,” he said.
Objections
Not everyone agrees.
“We’re shocked that the minister of health has committed to corporate self-regulation of these gene-edited foods,” said Lucy Sharratt, co-ordinator of the Canadian Biotechnology Action Network (CBAN) in a May 18 news release.
CBAN consists of 15 groups — including the Canadian Organic Growers, Council of Canadians, National Farmers Union, as well as several provincial organic or ecology groups and organizations opposing GMOs — with a mandate of scrutinizing genetic modification in food and farming.
“Canadians will soon be eating some gene-edited foods that have not gone through any independent government safety checks, and some of these foods may not even be reported by companies to the government or public,” Sharratt said.
In November, 105 organizations wrote to the federal ministers of agriculture and health to demand government oversight of all genetically engineered foods.
“Gene editing can be imprecise,” they wrote. “Even making small changes in a DNA sequence can have big effects. Possible unintended effects need to be looked for and assessed for safety.”
Groups like CBAN cite concern over the potential for unintended consequences — called “off-target effects,” such as making a plant toxic — which they argue companies may fail or neglect to catch before a product goes into the food supply.
In 2020, the network published a report, “Genome Editing in Food and Farming: Risks and Unexpected Consequences,” which pointed to such observed off-target effects. The report further argued that few studies search for those effects and that there are no protocols for detecting them.
“These off-target effects can cause changes in biochemistry or protein production, both of which are important for food and environmental safety,” the report read.
Part of the issue, Sharratt told the Co-operator in an interview, is that these gene editing techniques are new and few gene editing mechanisms have been developed to the point of commercialization. The CRISPR technology is about 10 years old. She argued that, therefore, Health Canada should be checking on them instead of trusting companies to do their own safety checks in an unbiased way.
Not checking on gene-edited foods means there also won’t be any definitive list of these products, Sharratt said.
Health Canada announced a transparency initiative where developers can voluntarily submit information about their products, but Sharratt argues that this list will be incomplete and unverifiable.
She also expressed concern that certain markets — such as organics, which don’t allow gene-edited foods — would lose trust in Canadian food and that the move would undermine consumer trust.
“It could damage some markets domestically and internationally,” Sharratt said.
Response
From Skori’s perspective, the safety bar is still pretty high.
“(Health Canada has) done a good thing,” he said.
It’s pretty standard, even required, for scientists to check for off-target edits, he added. Likely, if a researcher is targeting a specific gene, they’d sequence the DNA blueprint of the new cultivar so they can find any off-target edits and remove them from the plants.
That’s important, Skori said. They want the edits to be precise.
Plants produced via gene editing will still need to go through the same assessment process as more traditionally produced varieties, Bilichak said, adding that the companies would need to submit documentation including proof that these products don’t contain novel traits.
It may be important to add that off-target effects aren’t unique to gene editing.
“The scientific opinion acknowledges that unintended genetic changes can occur in plants when using gene editing technologies,” Health Canada wrote on its website. “However, both the scientific literature and opinions from experts in the field of plant breeding confirm that these changes aren’t unique to gene editing and can occur through all methods of plant breeding.”
For instance, breeders sometimes use mutagenesis to create genetic variation in the plants they’re developing, said Bilichak.
This means using a mutagen — such as radiation or chemicals — to create widespread genetic variation. Going back to the book analogy, this would be like making random cuts all over the page. The researchers can then pick the variations that look promising and discard the rest.
“There’s a consensus that the use of gene editing technologies doesn’t present any unique safety concerns compared to other more conventional methods of plant breeding,” Health Canada said. “As such, Health Canada should regulate gene-edited products of plant breeding in the same manner as all other products of plant breeding as described in the new guidance.”
“Honestly, it’s not as complicated as you’d think it would be,” Skori said. “You build a system and you put it in the plant, and it does its thing. It’s pretty incredible.
“Scientists want to use this tool to benefit farmers and consumers and humanity,” he added. “There’s no malicious intent behind gene editing.”
BACKGROUND: What’s being edited?
A primer on gene-edited crops, and a recent Health Canada decision that deemed them safe for food, is perhaps most simply done by analogy.
Imagine a plant’s genome as a book containing all the genes or genetic material in the plant, Andriy Bilichak, a researcher with Agriculture and Agri-Food Canada (AAFC), said. Chromosomes are the chapters of the book, and the paragraphs are parts of those chromosomes. The sentences are genes, words are parts of genes, and individual letters are the building blocks of DNA.
In his lab, Bilichak uses a molecular “tool” called CRISPR Cas9, which could be imagined as a scissor. It cuts the DNA at a defined position so it can change a single “letter” at a time and thus can introduce a new trait to the plant.
Gene editing tools can potentially remove, add or substitute the “letters” within the “words” of a plant’s genome.
“It’s more precise as compared to conventional breeding practices, and it allows (us) to introduce changes to the DNA faster and in a more controllable way,” Bilichak said.
Assuming the gene (or genes) that affect a specific trait is known, plant researchers can alter that specific gene instead of going through multiple rounds of breeding and selection.
In an industry where it often takes a decade or more to develop a new wheat or other crop variety, the technology can significantly reduce the time needed to bring a new cultivar to market, Bilichak said.
Instead of a decade, varieties developed in this method could see the market in as short as three years, including the time needed to propagate the new variety through a few generations to assess it and do final touches, something that could significantly cut the cost of developing those varieties. — G.W.
