Regulating the ‘product’ not the ‘process’ — Canada’s revised genetic engineering regulations poised to open the door to crop innovation

By Ralph Pearce, CG Production Editor

It’s been 30 years since Canada’s regulatory system for plant breeding innovation was last reviewed, but since then, genetically modified organisms (GMO) technology has become an important feature. More recently, there have been advancements in gene editing such as with CRISPR Cas9, RNAi and epigenetics. These changes, among others, prompted a Health Canada review of its Guidelines for the Safety Assessment of Novel Foods, which were updated in July.

The underlying driver of this clarification — there are no changes to any rules or regulations governing gene editing — is the need to assess new developments according to ″product-based″ and not ″process-based″ research. Doing so will lead to greater development of new varieties and hybrids, not just in row crops like soybeans or corn, but in oats, barley, peas, chickpeas and lentils, as well as fruits and vegetables. The review will provide the flexibility and scope to allow for things seen and as-of-yet unseen by the scientific community. 

Broader definitions

Mounting world food security issues are also concurrent and underlying factors, says Krista Thomas, vice-president of seed innovation and trade policy with the Canada Grains Council. She says she’s pleased that Health Canada’s guidance sets out clear, science-based rules that support nutritional, environmental and production enhancements to grains and oilseeds. It means improved varieties, regardless of how they were developed, can get into the hands of farmers without unnecessary regulatory burden or delays.

″This update also benefits conventional plant breeding, which has been under stricter rules in Canada than any other country for decades,″ says Thomas. ″Now, Canadian companies and researchers have a more level playing field, whether they are using gene editing or not. No matter how a plant’s developed, if it has certain characteristics, like a major nutritional change or a new allergen, Health Canada must review it. This helps to future-proof Canada’s regulatory approach.″ 

More efficient breeding

Among researchers and plant breeders, the increased potential for discovery from CRISPR and RNAi has been an almost ″quantum leap″ for precise, targeted changes to a plant’s DNA. One researcher from Agriculture and Agri- Food Canada (AAFC) called gene editing ″correcting a spelling mistake.″ Could science continue doing what it’s always done in the past? Yes, but Thomas likens the opportunity to assembling do-it-yourself furniture using the enclosed wrench in the package. Gene editing is like having a power ratchet: it’s still the same product in the end, but it’s built faster and easier. 

″This (gene-editing) process mirrors what can happen in nature or through traditional plant breeding, but in a more efficient way. For example, a plant breeder with a small budget working on a small- acre crop can potentially produce more improved varieties in less time.″ 

Avoiding misinformation

Canada could have the best regulatory approach in the world but farmers won’t be able to grow gene-edited crops unless customers accept them. The transparency tools and early communication channels are already in place to support market-access discussions, so the acceptance of a new gene-edited variety will be discussed by the value chain long before seed is offered for sale. 

In spite of the science-based approach by Health Canada, there have been some who question the changes. An article in the National Observer in March 2021 discussed the revised guidelines but focused on some perceived failings of the system. 

Author Loren Rieseberg, a professor of botany at the University of British Columbia, supported the review by Health Canada and the benefits of gene editing. He said the regulatory focus on novel traits provides greater flexibility than regulatory systems elsewhere and applications might increase slightly since applicants will have greater clarity about what to expect. 

″The changes mean that many edited products will not be considered novel and so will not be subject to regulatory approval,″ says Rieseberg. ″This will encourage the use of gene editing to manipulate traits that are targeted in conventional breeding programs, like resistance to disease or drought, or increases in yield, and thus would not be viewed as novel.″

Another benefit of the changes is the reduced regulatory cost, which Thomas says will allow smaller players to participate. Yet Rieseberg believes there is the potential for less transparency compared to transgenic approaches about the techniques used to develop a particular trait or variety. 

″This is consistent with how most other breeding approaches are regulated, like mutagenesis or grafting,″ he says. ″The consumer typically is unaware, for example, that most pink or red grapefruits are mutant products of ionizing radiation. The advantage of gene editing is that mutagenesis is targeted, whereas conventional mutagens produce random changes, and it can be tedious to find the one you want and get rid of the ones you don’t.″ 

Other savings

The Health Canada clarification will bring other savings, says Ian Affleck, vice-president of plant biotechnology at CropLife Canada. Referring to work by Curtis Pozniak and his team at the Crop Development Centre at the University of Saskatchewan, Affleck notes the new document will provide the opportunity to retain more of the breeding lines that are brought forward as potential new varieties. 

Pozniak’s team has written about the costs of screening a thousand lines in the hope of finding one that’s suitable to bring to market. In the last stages of that effort, that’s reduced to 80 lines which are almost ″good enough″ or ″near misses.″ 

″With gene editing, groups like the Crop Development Centre can go back and maybe save 30 of those lines and bring them forward,″ says Affleck. ″For 80 different lines, the breeder just saved eight years of research that are no longer going in the trash can, so there’s the economy of plant breeding.″ 

He says this will make plant breeding significantly cheaper and allow varieties to make it to market sooner. ″So instead of waiting 10 years for 10 per cent more disease resistance, you might only have to wait seven or five years. Then because of that value and if both the cost of breeding is lower and the regulatory costs are lower, you can get into crops where you couldn’t have made those improvements before, like peas, lentils, chickpeas and barley, which haven’t seen the same level of innovation. Hopefully, some of these other crop kinds can receive some attention, and not just for in-field traits but for value-added traits.″ 

The more familiar players in the biotech field — Bayer, BASF, Corteva and Syngenta — will be able to add to their offerings through this latest policy clarification, while others such as Yield10, Calyxt and Inari are also entering the space. 

Affleck says transparency remains an important requirement, both for market access and public engagement. The seed sector is committed to that and has committed to providing transparency for varieties developed via gene editing through a new resource that’s being finalized via Seeds Canada for availability later this fall. 

″The important part is ensuring the plant-breeding community can continue to provide the best possible varieties to farmers as they try to achieve those goals,″ says Affleck. ″There’s so much pressure on Canadian farmers and making sure they have access to the best varieties, on par with their competitors in other countries, is going to be key to our success.″

This article was originally published in the September 2022 issue of the Corn Guide.