Health Canada plans to publish a new guidance document that could have a profound impact on crop breeding in this country, says an industry official.
The document will clarify what the government deems to be plants with novel traits, which are crops that are subject to regulation.
Seed companies hope the new definition will create a more predictable and transparent system for crop breeders.
“We’re encouraged to see that the government is taking this very seriously,” said Ian Affleck, vice-president of plant biotechnology with CropLife Canada.
“They recognize it’s a priority and they’re moving forward on consultations to modernize their framework.”
He worries that Canada is falling behind other countries like the United States, Australia, Argentina and Japan on how to handle new breeding techniques, such as gene editing.
Those jurisdictions have decided that gene editing technologies such as CRISPR do not require the same pre-market assessment that genetically modified crops require because the same outcome could be achieved through conventional breeding.
Canada’s regulatory system is focused on the end product rather than the process used to create that product. It cares about what was created rather than how it was created.
Anything considered novel is subject to regulation and therein lies the rub.
“Plant breeders are always breeding for novelty. That’s what they do. They want the next variety to be different from the last one. So hence the confusion,” said Affleck.
That ambiguity over what new breeding developments are going to be deemed novel is chasing investment out of Canada toward jurisdictions where there is more regulatory certainty.
“We just have to be more specific about what we mean is novel,” he said.
Lucy Sharratt, co-ordinator of the Canadian Biotechnology Action Network, fears what is coming.
“We know what CropLife would like to see and we’re very concerned that the consultation document will propose just that, which is exemptions to regulation, tiered regulation and fast-tracking regulation,” she said.
Sharratt believes crops developed through gene-editing techniques are going to somehow be exempted from regulation.
She doesn’t like how Canada’s system ignores what process was used to create a crop.
“It’s highly relevant in risk assessment to understand what the process was that created a novel trait,” she said.
Gene editing is a new technique that deserves to be regulated until there is a better understanding of the science involved, said Sharratt.
The guidance document was originally scheduled to be published in January 2021 but Affleck thinks it is more likely to be in mid-February. There will be a 60-day comment period after the document is published.
Erin Gowriluk, executive director of Grain Growers of Canada, said it is imperative that Ottawa gets the details right.
“It’s going to have a direct impact on farmers and their ability to compete in the international marketplace,” she said.
Growers in competing exporting regions like the U.S., Australia and Argentina will have a competitive advantage over their Canadian counterparts if Canada decides that crops made through gene editing techniques are going to require lengthy regulatory reviews, said Gowriluk.
She agreed with Affleck that sticking with an unpredictable system will chase away investment by seed technology firms.
“Our concern is that they’re going to be more inclined to make those investments in other countries where they operate where the regulation is far more clear,” said Gowriluk.
Affleck said the regulatory review process can take up to two years.
That is why it is critical that Canada’s system for regulating gene edited crops is no more burdensome than the U.S. and other jurisdictions.
“This is our opportunity to catch up,” he said.
Sharratt said it is too soon for Canada to decide whether or not gene edited crops should be regulated.
She thinks it could threaten Canadian agricultural exports to markets like the European Union where a court ruled that gene edited crops need to face the same scrutiny as genetically modified crops.
“This is not a settled issue internationally,” she said.
Sharratt also noted that Health Canada wants to publish its final guidance document by the end of April, which doesn’t leave much time for it to process feedback on the document.
“We’re very concerned this is a rushed consultation,” she said.
Affleck said the new guidance document should help conventional breeders as well because their crops can also be subject to extra scrutiny if deemed novel.
Crops developed through gene editing techniques are just starting to hit the market. The first major example is a soybean crop developed by Calyxt Inc. that produces high oleic oil. The company produced four million bushels of the crop in the U.S. in 2020.
Other gene-edited crops in the works are a high-fibre wheat and a non-browning potato. But the technology really shines when it comes to creating disease resistance.
“That is not going to make headline news because it’s not a consumer trait, but that is going to be super impactful on farmers,” said Affleck.
And that is precisely why he is pleased that Health Canada appears to be serious about clarifying the definition of what exactly constitutes a plant with novel traits.
“We’re very confident that our government can deliver that clarity through these consultations,” he said.