The product, not the process

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It’s been 30 years since Canada’s regulatory system for plant breeding innovation was last overhauled, but since then genetically modified organism (GMO) technology has become a prominent feature. More recently, there have been advances in gene editing, such as with CRISPR Cas9, RNAi and epigenetics. These and other changes prompted Health Canada to revise 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 the rules or regulations governing gene editing – is the need to evaluate new developments on the basis of “product-based” research, not ” process-based. This will lead to greater development of new varieties and hybrids, not only in row crops such as 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 not yet seen by the scientific community.

Broader definitions

Growing global food security issues are also concurrent and underlying factors, says Krista Thomas, vice president of seed innovation and trade policy at the Canada Grains Council. She says she’s glad Health Canada’s guidelines set out clear, science-based rules that support nutritional, environmental and production improvements in grains and oilseeds. This means that improved varieties, regardless of how they were developed, can get into the hands of farmers without unnecessary regulatory burdens or delays.

“This update also benefits conventional plant breeding, which has been subject to stricter rules in Canada than in any other country for decades,” says Thomas. “Now Canadian companies and researchers have a more level playing field whether or not they use gene editing. Regardless of how a plant developed, if it exhibits certain characteristics, such as a major nutritional change or a new allergen, Health Canada must review it. This helps secure Canada’s regulatory approach.

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More efficient farming

Among researchers and plant breeders, the increased potential for discovery of CRISPR and RNAi has been a “quantum leap” for precise and targeted modifications to a plant’s DNA. An Agriculture and Agri-Food Canada (AAFC) researcher called gene editing “a spelling mistake”. Could science continue to do what it has always done in the past? Yes, but Thomas compares the possibility of assembling do-it-yourself furniture using the key provided in the package. Gene editing is like having a power ratchet: it’s still the same product at the end of the day, but it’s built faster and easier.

“This process (of gene editing) mirrors what can happen in nature or through traditional plant breeding, but more efficiently. For example, a plant breeder with a small budget working on a small cultivation area can potentially produce more improved varieties in less time.

Avoid misinformation

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

Despite Health Canada’s scientific approach, some question the changes. An article in the National Observer in March 2021 discussed the revised guidelines, but focused on some perceived shortcomings of the system.

Author Loren Rieseberg, 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 new traits provides greater flexibility than regulatory systems elsewhere and that demands could increase slightly since applicants will have greater clarity on what to expect.

“The changes mean that many edited products will not be considered new and therefore will not be subject to regulatory approval,” Rieseberg says. “This will encourage the use of gene editing to manipulate traits targeted in conventional breeding programs, such as disease or drought resistance, or yield enhancement, and would therefore not be considered novel. ”

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

“It matches the way most other breeding approaches are regulated, like mutagenesis or grafting,” he says. “The consumer is generally 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 cumbersome to find the ones you want and get rid of the ones you don’t.

Other savings

Health Canada’s clarification will bring further savings, says Ian Affleck, vice-president of plant biotechnology at CropLife Canada. Referring to work by Curtis Pozniak and his team at the University of Saskatchewan’s Crop Development Centre, Affleck notes that the new document will provide the opportunity to conserve more genetic lines presented as potential new varieties.

The Pozniak team wrote about the costs of testing a thousand lines in hopes of finding one that could be brought to market. In the later stages of this effort, this is whittled down to 80 lines that are almost “good enough” or “almost failed”.

“With gene editing, groups like the Crop Development Center can go back and maybe save 30 of these lines and move them forward,” says Affleck. “For 80 different lines, the breeder has just saved eight years of research that no longer goes to waste, so that’s the economics of plant breeding.”

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

Biotech’s most familiar players – Bayer, BASF, Corteva and Syngenta – will be able to complete their offerings with 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 industry is committed to this and is committed to providing transparency for varieties developed through genetic modification through a new resource that is being finalized through Seeds Canada to be available later this fall.

“The important thing is to ensure that the plant breeding community can continue to provide the best possible varieties to farmers as they try to achieve these goals,” says Affleck. “There is so much pressure on Canadian farmers and ensuring they have access to the best varieties, on par with their competitors in other countries, will be key to our success.

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

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