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Introducing plants with novel traits

Modern farming relies on a combination of the “old” and the “new,” where agricultural systems are built on time-tested knowledge, but rely on constant innovation.

“Novelty,” as it applies to innovations in plant breeding, is subject to rigorous regulatory standards to ensure plants with novel traits (PNTs) increase productivity without unintended effects on systems over time. A PNT can be defined as a variety of a species that contains one or more traits that are new to the species. Novel traits are used for a range of functions in crops across Canada – from heightened insect and disease resistance to improved agronomic performance.

According to Denis Schryburt, acting manager for the media relations office of the Canadian Food Inspection Agency (CFIA), novel traits can be introduced using conventional breeding methods, biotechnology or mutagenesis in Canada. Resulting products are evaluated by CFIA based on their performance. “The Canadian biotechnology regulatory system is based on the principle of novelty, meaning that products are regulated based on their characteristics and not by the process by which they were made,” Schryburt says.

Schryburt says that the CFIA defines “novelty” differently depending on how the product is being used. The CFIA is responsible for assessing the safety of new products for release into the environment and use as livestock feed. Health Canada, on the other hand, assesses the product’s safety for use as food.

“In the context of environmental release, we use the term ‘plant with novel traits’ to [describe] a plant that contains a trait that is both new to the Canadian environment and has the potential to affect the specific use and safety of the plant with respect to the environment and human health,” Schryburt explains.

In novel feeds derived from plant sources, novel traits refer to heritable characteristics that are new to the plant species, or endogenous traits that have been modified to behave outside the plant’s conventional parameters.

With regard to novel foods, a novel trait is the introduction of a new or altered characteristic not previously observed in that plant.

The CFIA determines the safety of new products differently for each category. For PNTs, the CFIA evaluates the potential of the plant to become a weed or to be invasive, the potential consequences of gene flow to wild relatives, the potential to increase the activity of a plant pest, the potential impact on non-target species and the potential impact on biodiversity.

Once safety evaluations have been completed for each PNT, the CFIA and Health Canada post documents outlining the rationale for the decision. “Some of the recently authorized products include herbicide-tolerant canola, herbicide-tolerant and insect-resistant corn, and soybean that has increased yield potential,” Schryburt says.

Three case studies
The CFIA and Health Canada post “notices of submission” for public comment for each new PNT under review on the CFIA website.

The three items that top the list are Monsanto corn products: MON 87419, genetically modified to exhibit herbicide tolerance; MON 87403, genetically modified for increased ear biomass; and MON 87411, genetically modified for insect resistance and herbicide tolerance. Each PNT includes a novel trait based on the use of novel genes or uses a previously approved gene in a new crop type.

MON 87419 uses DMO, or a dicamba mono-oxygenase protein conferring tolerance to the herbicide dicamba, for the first time in corn, though it’s been approved in cotton and soybeans. MON 87403 uses a novel gene, the ATHB17 gene from the plant Arabidopsis thaliana, for the first time in any plant, to increase corn ear biomass. MON 87411 contains a novel insecticide trait that uses RNA interference to target SNF7, an essential protein involved in intercellular trafficking in corn rootworm.

According to Kevin Gellatly, regulatory affairs manager for biotechnology with Monsanto Canada, bringing a new genetically engineered crop to farmers’ fields is a long and expensive enterprise that costs an average of US$136 million, and takes at least 13 years from product concept to launch.

Monsanto divides the regulatory process into five “phases”: the discovery phase, during which genes or traits are identified (54 months); phase 1, or “proof of concept,” (27 months); phase 2 for early development (30 months); phase 3 for advanced development (37 months) and phase 4 for prelaunch (49 months).

Gellatly says the discovery phase begins with Monsanto’s team whittling down a list of thousands of potential gene candidates to primary and secondary candidates, with gene candidates exhibiting potential risks to humans, livestock or the environment eliminated before phase 4. “By the end of phase 4, a single candidate will have been selected based on years of laboratory and field testing, including well-designed scientific studies that must meet the requirements of scientists from dozens of global regulatory organizations,” he says.

Gellatly says each of Monsanto’s three new PNTs is at the regulatory approval stage, “which places their progress around the beginning of phase 4,” he explains. “If we include the discovery phase, these PNTs have been ‘in the works’ for approximately 13 years.”

The regulatory process is similar for all three PNTs, according to Gellatly. “In Canada, duplicate dossiers are submitted to the Health Canada Novel Foods Division and CFIA’s Animal Feed Division, which independently review food and feed safety data, respectively, and determine whether the product is authorized for use as food and feed,” he says. “A separate dossier is submitted to the CFIA Plant Biosafety Office which reviews the environmental safety data and determines whether the product is authorized for environmental release.”

Each dossier contains descriptions of the host plant, the modification, the inheritance and stability of the introduced trait, and the novel traits, proof of the absence of toxicity of the novel gene products, a nutritional evaluation of the novel plant, allergenicity/toxicity considerations, and an evaluation of the environmental impact of the novel plant. Historically, Monsanto products receive Canadian food, feed and environmental authorization approximately two years before they are eligible for commercial launch, Gellatly says. However, due to changes in some international regulatory systems, launch dates for new products are less certain due to lengthening global approval timelines.