Canada is changing its risk assessment policy for genetically modified plants and food products sold at home and overseas.
Genetically modified organisms (GMOs) that contain foreign DNA will still be subject to government regulatory oversight. However, a new category of GMOs – gene-edited organisms that do not contain foreign DNA – will be exempt from safety assessments by Health Canada and the Canadian Food Inspection Agency (CFIA). To date, these are mostly crops like corn that have been modified to enhance a specific, naturally occurring characteristic, such as high corn starch content.
Gene-editing techniques are also common in medicine, including in vaccines like the AstraZeneca COVID-19 inoculation.
Here’s what you need to know about gene editing and the new rules for plants and foods:
What is gene editing?
Gene editing (or genome editing) refers to a suite of new techniques that can change an organism's DNA at a specific spot on its genome. The techniques can use foreign DNA to make the genetic changes but, unlike previous kinds of GMOs, do not always leave behind foreign DNA in the final organism.
These technologies allow scientists to add specific, desirable traits to an organism's genome, or boost or suppress those already present. Gene editing bypasses the lengthier, less precise methods used in traditional breeding or earlier generations of genetic modification. They are also faster and cheaper than older genetic-modification techniques and are regularly used outside of agriculture: for instance, the AstraZeneca COVID-19 vaccine relies on gene editing. CRISPR-Cas9 is the most well-known gene-editing technology.
Gene editing makes it easier to ensure an organism will have desirable traits than traditional breeding, explains Loren Rieseberg, professor of botany at the University of British Columbia. That is because traditional breeding gradually enhances desirable genes over several generations and can be accompanied by genes that exhibit less useful traits. In contrast, gene editing allows scientists to achieve similar changes to an organism's genetic code in a single generation.
Seeds for crops like canola and corn are currently the organisms most impacted by gene-editing guidance being developed by Health Canada and the CFIA.
What is the difference between gene-edited and GMO plants and foods?
Gene-edited plants differ from traditional GMOs because the method used to modify their genetic codes differs, and they often don't contain DNA from another organism. Older genetic-modification techniques added entire segments of foreign DNA to an organism's genome to obtain desirable traits. In contrast, gene editing changes only a few base pairs – the genome's building blocks – within the organism's DNA to alter a specific gene.
Do we have gene-edited products for sale in Canada now?
In 2013, the agri-tech company Cibus commercialized a canola it said was gene-edited using a proprietary process. At the time, it was approved for use in Canada by Health Canada and the CFIA. However, the company said last year the plant was not gene-edited and the technical information submitted to Health Canada and the CFIA during the approval process was misinterpreted. In July 2020, Health Canada and the CFIA changed their approval documents for the plant, indicating it was not gene-edited.
What does "non-novel" mean?
Health Canada and the CFIA categorize new organisms into two categories, "novel" and "non-novel." In the context of gene editing:
"Novel" organisms have traits that are not naturally occurring and have not been previously approved for sale by Health Canada and the CFIA. Organisms that pose an obvious risk – they could be toxic or cause an allergic reaction, for instance – or that contain foreign DNA in the final product are considered novel.
"Non-novel" organisms are organisms that have a history of safe use, show no characteristics that are new to the species and do not contain genetic material from another organism after its genome has been edited.
How does Canada regulate GMO products now, and what will change?
Currently, GMOs on the market in Canada must pass through Health Canada and the CFIA to determine if they are "novel." If so, they are subject to regulatory oversight; seeds that exhibit "non-novel" traits will not.
Under the planned guidance, it will be left to companies to decide which products are “novel” and must be sent to Health Canada and the CFIA for oversight. Lucy Sharratt, co-ordinator for the Canadian Biotechnology Action Network (CBAN), says safety assessment guidelines will still be developed by the health and food safety agencies, but it will be left to the companies developing gene-edited seeds to follow them.
"The information that we have shows that (Health Canada and the CFIA) may provide a list of gene-editing techniques that it considers to be safe," she said. The companies will decide which of their products fit that description.
What is the business advantage to this system?
Reducing regulatory hurdles will make developing gene-edited crops significantly cheaper, UBC’s Rieseberg says. That could allow seed developers to foster a wider diversity of traits, like making the plants more resilient or nutritious.
It will also make it easier for companies to patent a greater diversity of crops, maximizing their profits through the sale of patented seed.
Are other countries taking the same approach?
Not the EU. In 2018, the Court of Justice of the European Union ruled all gene-edited crops undergo regulatory oversight before going to market. That decision built on the bloc's already stringent regulatory approach to GMOs.
Canada initially indicated it would follow the European lead. However, the proposed regulations now mirror the more lax approach taken by the U.S., Australia and other countries. According to a timeline of the process provided to CBAN by Health Canada, early versions of the guidance – released in July 2020 – would have seen all gene-edited organisms and foods assessed by Health Canada. By February 2021, those requirements were gone.
The decision came after several meetings with industry, public- and private-sector plant breeders and reviews of the relevant scientific literature, Health Canada said in a statement.
Should we be worried about these new regulations?
Depends who you ask. Sharratt believes seed developers are motivated primarily by profit. Companies will invest in creating non-novel, gene-edited plants either because they have a specific use within industrial agricultural systems – reducing pesticide use, for instance – or as a way to patent specific crops.
Gene editing isn't foolproof, says Sharratt, and can still create genetic errors that could have unknown health impacts.
"If the assumption is there that the process of gene editing is safe, will anyone look for the unexpected effects?"
But Reiseberg concurs with Health Canada's assessment that non-novel gene-edited plants are safe to eat without further regulatory oversight.
Sharratt also notes the planned guidance will not force companies to be transparent about which seeds are gene-edited. Under the new rules, the government, farmers and consumers will only know their seeds have been gene-edited if plant developers participate in Health Canada's voluntary transparency initiative, which will publish information on new plants on the ministry's website, Health Canada noted in a statement.
Health Canada and the CFIA both say there are no plans to track where gene-edited crops end up.
"As with any other food, Health Canada does not monitor the market penetration of foods in the Canadian food supply ... CFIA [also] does not track information about the commercial status of plants based on their method of development, because their impact on the environment is considered to be the same as those already on the market," Health Canada said in a statement.