b'unmodified counterpart. The need for an assessment is based on theCLARITY ON NOVEL FOODSfinal product, not the process used to create the product.According to its guidance document issued for the consultations, it is Health Most of the rest of the worldCanadas position that the following five categories of foods would not add has a more process-based triggerto our body of knowledge about their safety, if assessed individually as novel for pre-market oversight. In Canada,foods because their safety is already well characterized. In other words, weve always had a product-basedHealth Canada may not classify the following as novel:approach. Its not supposed to matter what method you use to develop theFoods derived from plants with genetic modifications that do not contain a product, its the final characteristicsknown allergen or toxin relevant to human healthof the product itself that determine Foods derived from plants with genetic modifications that do not increase whether its a PNT, says Jennifer Hubert, plant biotechnology directorlevels of an endogenous allergen, an endogenous toxin or an endogenous for CropLife Canada.anti-nutrient beyond the documented rangeWhile that is indeed a more Foods derived from plants with genetic modifications that do not have an science-based approach to oversight,impact on key nutritional composition and/or metabolismit comes with its own challenges. The result, she says, is ambigu-Foods derived from plants with genetic modifications that do not change the ity around when a product is novelfood use of the plantand what characteristics make it so. Foods derived from plants with genetic modifications that are not the result of This ambiguity is really prob- the insertion of foreign DNAlematic with the emergence of new technologies, such as gene editing, because these problems are exacer-bated without additional clarity on what makes a food novel. were seeing in the Health Canada consultations. Were Canada has had 20 per cent morevery glad to see Health Canada maintaining a science-products go through pre-market over- based approach and speaking confidently about the sci-sight compared to any other country,ence and the safety of gene editing. Were also pleased to Hubert adds. see Health Canada moving into closer alignment with the Thats where were really lookingrest of the world, Thomas says. to level the playing field with the restFor innovation to be launched successfully in Canada, of the world and improve clarity towe need to have market access as well, because so much help plant breeders determine novelty. of our grain crops are exported. International alignment is critically important for that market access, and it can beStuart Smyth is When is Something Considered Novel? difficult to ask for market access when youre representingenhancement chair in The Health Canada consultations dothe one country that does things differently in the world. agri-food innovation not constitute a safety examination ofHubert notes that most countries around the worldand sustainability gene editing. Rather, its an exami- are going in a direction where products of gene editingat the University of Saskatchewan.nation of the product developmentwill not be part of their GMO legislation, but they will process to decide when a certainhave some sort of oversight requirements. Countries like product would be considered novel. Japan, Australia, and the United States as well as many Health Canada says its intent isSouth American countries are taking this approach.to ensure that its guidance providesThe result, notes University of Saskatchewan enhance-greater clarity, predictability, andment chair in agri-food innovation and sustainability transparency regarding the regulationStuart Smyth, are regulatory environments in those of novel foods derived from plants,countries that are more conducive to plant breeding inno-including those developed using genevation. A survey of plant breeding that Smyth recently editing technologies. It also wants toconducted found one-third of respondents have chosen ensure that it provides an efficientnot to pursue a research project if they thought it might and predictable pathway to commer- result in a novel trait.Krista Thomas is vice-cialization for new products, knownThe biggest thing that has handcuffed plant breedingpresident trade policy as pre-market assessment.in Canada is the additional regulatory compliance costs of seed innovation with the Canada There are a lot of positives thatPNTs. I wont say its completely excluded public breed- Grains Council.20GERMINATION.CAJULY 2021'