UPDATED, June 24, 2016: Plants modified using the controversial gene editing technology known as CRISPR/Cas-9 won’t be sailing past regulatory scrutiny to the marketplace in Canada as they currently do in the U.S.
While the U.S. regulatory system has determined plants developed using CRISPR are not GMOs and therefore do not fall under the regulatory process, Canada takes a much broader approach to assessing new plant-modification technology.
“In Canada the approach to the regulatory oversight is based on the novelty of the product rather than the means of development,” said Cindy Pearson, national manager of the Plant Biosafety Office with the Canadian Food Inspection Agency.
“If there is a new trait in there, then it would trigger the need for a pre-market assessment.”
Since it was developed in the mid-1990s to deal with the first genetically modified crops in the pipeline, the federal government’s Plants with Novel Traits regulatory process has been applied to plants produced through biotechnology or genetic engineering as well as conventional breeding techniques.
Pearson said plants using CRISPR/Cas-9 technology are considered to have novel traits, which means they will be assessed by Health Canada for their safety as a food, and by the CFIA for environmental safety and use as livestock feed.
To date, no applications for plants developed using the technique have come forward in this country, she said.
‘Search and replace’
Despite its complicated name, “clustered regularly interspaced short palindromic repeats,” CRISPR dramatically simplifies the gene editing process. Likened to a “search-and-replace” function for genes, it is touted as a scientific breakthrough as important as transgenics, for which scientists insert genes from another species into a plant to change its behaviour.
“We’ve never been able to go in and make such a precise change as we can now with gene editing,” Wendy Harwood, a John Innes Centre scientist based in Norwich, England told Reuters. “This gives you exactly the change you want without anything you don’t want.”
She is using the technology to tweak barley plants into producing better germination with higher yield and quality.
And it is not limited to plants. Scientists believe they can use the technique to alter the reproductive ability of malaria-carrying mosquitoes, produce disease-resistant pigs and develop crops that are more resilient to pests and environmental stressors. It is also seen as reshaping the world of biomedical research.
But it is mired in controversies ranging from a deepening spat over which researchers discovered it first and therefore gain control of lucrative patents, to whether it should be used on human beings, to how it should be regulated, if at all.
U.S. regulatory authorities waved through the first plant developed using CRISPR/Cas-9 earlier this year, a button mushroom that doesn’t brown. But the U.S. government has also announced a review of its regulatory process.
In Europe, which has never fully embraced GMOs, a new debate is brewing.
The European Commission has so far not made a decision on how it will be regulated, leaving the new science in limbo.
GMO or not?
Unlike traditional GMOs, in which a gene is added from another organism, gene editing works like the find-and-replace function on a word processor. It finds a gene and then makes changes by amending or deleting it.
Proponents argue this makes it similar to conventional selective breeding, since such mutations within the same species can — and do — also occur naturally.
Greenpeace wants the EU’s GMO law to be fully applied to “new breeding techniques” like gene editing, because of potential environmental and health impacts, and it fears Brussels is dithering under pressure from Washington.
Biotechnology companies, meanwhile, argue their gene-edited products are “non-GMO,” since they do not contain foreign DNA from a different species.
Rene Smulders, a plant breeder at Wageningen University in the Netherlands, says the current uncertainty is affecting research. His group had a grant application turned down last year because of concerns about the legal situation.
He wants Europe to follow Canada’s lead, which decides on new products based on their traits, not how those traits were produced. “Europe’s process-based legislation creates problems and is not suitable for the future,” Smulders said.
Cellectis CEO Andre Choulika, whose Calyxt unit has used older forms of gene editing to improve potatoes, wheat and soybeans, thinks the odds are 50:50 that gene editing will end up being classified as GMO in Europe.
“If Europe does that, I think it will probably send itself into the stone age of agricultural biotechnology,” he said.
Both sides in the debate are worried.
Agricultural scientists and companies worldwide are joining the gene editing race, including seeds giant Monsanto, now the target of a $62-billion takeover attempt by Germany’s Bayer.
Rival DuPont, which is merging with Dow Chemical, hopes to have CRISPR-edited corn and wheat on the market in five to 10 years.
Bright ideas from others include improved varieties of rice, soybeans and tomatoes, as well as hornless cattle and the heat-tolerant breed of Angus.
CLARIFICATION FROM SOURCE, June 24, 2016: After this article was originally published, the Canadian Food Inspection Agency has further clarified statements made in the piece. “Plant-breeding programs using CRISPR/Cas-9 may lead to the production of a plant with a novel trait,” a CFIA spokesperson said in an email. “It is not necessarily the case that all plants developed using CRISPR/Cas-9 will be regulated. Only those that have a novel trait will be regulated.”