Canada: Rules for gene editing a worry

Ian Affleck, vice-president of plant biotechnology with CropLife Canada, said gene-edited crops could hit the market in 2019 yet Health Canada and the Canadian Food Inspection Agency have given no indication if or how they will be regulated.
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Canadian breeders and seed technology companies are anxious about how regulators will handle new crops developed through gene editing.

Gene editing is the latest breakthrough in crop breeding. It involves tweaking existing genes within a plant as opposed to genetic modification, which involves inserting genes into a plant.

Ian Affleck, vice-president of plant biotechnology with CropLife Canada, said gene-edited crops could hit the market in 2019 yet Health Canada and the Canadian Food Inspection Agency have given no indication if or how they will be regulated.

“If that is not addressed soon, this uncertainty could most definitely put Canadian farmers and plant breeders at a disadvantage,” he said.

Innovators want a predictable marketplace. Affleck worries that the regulatory uncertainty that exists in Canada will chase investment away.

Many other jurisdictions have already decided how the new technology will be handled.

“The USDA has been crystal clear in recent weeks that they have no plans to regulate gene-edited plants going forward,” said Affleck.

That means crops made through gene-editing techniques such as CRISPR will be able to avoid the costly and time-consuming regulatory reviews that genetically modified crops have to endure.

Canada has a unique product-based regulatory process. Regulation is triggered by a novel trait regardless of what technology was used to introduce the trait.

“Our products-based approach casts a wider net,” said Affleck.

He hopes that net doesn’t include gene-edited crops because that would put the Canadian farm sector at a competitive disadvantage to the United States.

“Not only could that mean a longer process but also it will take longer for farmers to access tools that their competitors south of the border have access to and some innovations may not come here at all due to the added uncertainty and regulatory cost,” said Affleck.

Lucy Sharratt, co-ordinator of the Canadian Biotechnology Action Network, said Canada’s system is already in place and no further decision is necessary.

She worries that some gene-edited crops will bypass regulation because the traits will not be deemed novel.

“We’ve always contended that, actually, process matters and product-based regulation can fail to identify possible risks that are the results of the process used,” said Sharratt.

“We absolutely think that gene-edited products should be regulated. They should also be labelled.”

Stuart Smyth, agri-food innovation chair at the University of Saskatchewan, said regulatory reviews in Canada typically take about 18 to 22 months.

So, if gene-edited crops were regulated in Canada, farmers might have to wait nearly two years to get their hands on new crops already being grown in the U.S.

All of the plant breeders he has spoken to at the university use gene-editing techniques in their labs. They are worried about how it will be regulated at home and abroad.

“A lot of them are really concerned about how external export markets are going to regulate this,” he said.

The divisive issue has ended up in the European court system. France asked the European Court of Justice for an interpretation of the 2001 directive governing GM crops to see if gene editing would be subject to the same rules.

A recent article in the science journal Nature said a Jan. 18 ruling from an advocate general in the European Court of Justice suggests those regulations may not apply, at least not in all cases.

The European Court of Justice, which is the highest court in the European Union, is due to hand down its ruling later this year. The Nature article said the court often closely follows the advice of its advocates general.

Smyth was at a gene-editing conference in Munich, Germany, in March where one of the speakers said even if the court rules that the technology should not be regulated like GM crops, there is tremendous pressure on politicians to make the technology subject to the same laws.

“(That) would essentially kill the technology there and it will also kill it for the public sector globally,” he said.

Affleck said Canada has the opportunity to be a leader and influence how other countries decide to regulate gene editing.

He said it would be a shame if the exciting new breeding technology gets bogged down in burdensome and time-consuming regulation.

It is an inexpensive tool that could be especially useful for crops that haven’t seen the same level of investment as corn, soybeans and canola.

“This could be a real boon to crops like barley and the pulses moving forward,” he said.