4 GERMINATION.CA NOVEMBER 2017 IT’S A TRUTH universally acknowledged: launching new technology carries risk. In the seed industry, the risks involved with launching new seed technology are intensified by the enormous cost associated with testing and fulfilling regulatory requirements. Does the technology meet a need that will still exist by the time the product has com- pleted development? Will the product receive registration in Canada and other key markets? Will it perform as intended? Will customers buy it? Just how carefully companies manage risk — from product devel- opment to product launch — may determine that product’s success or failure. Product Development Before a company decides to launch a product, they must go through rigorous evaluation to ensure the product does exactly what it’s sup- posed to do. This evaluation includes testing the product’s behaviour in con- tained trials to ensure it’s working as expected. But it also involves the identification of unique risks associ- ated with the product. “Each technology has its own risk base — that’s where science comes in. The developers define each technol- ogy’s new risk,” says Lorne Hadley, executive director of the Canadian Plant Technology Agency (CPTA), which was formed in 1997 in response to the need for a combined voice for intellectual property rights issues. “There are a lot of steps involved in bringing new products to market,” adds Darrel Armstrong, Monsanto Canada’s stewardship lead. When Monsanto is developing a new product, the company performs risk assessments at key points along the product development pipeline. “Let’s say it was a new herbi- cide tolerant technology, something that hasn’t been introduced into the Canadian environment — you’d want to understand the implications of managing that in a confined field trial,” Armstrong says. “Traditional practices for control- ling volunteers may not work anymore because it’s a new herbicide tolerance. So then you’d adjust your steward- ship plans and containment plans to ensure controls are appropriate for the new technology.” WHAT’SKEEPINGINNOVATORSAWAKE? Risk is involved in every new product release, but successful companies manage it by listening to end-users. Julienne Isaacs Regulatory Hurdles Launching a new trait comes with specific regulatory requirements in Canada and its export markets. According to Ian Affleck, execu- tive director of plant biotechnology for CropLife Canada, most crops with new biotech traits will not be launched in Canada until they achieve regulatory approval in key export markets. “When you’re innovating in a certain crop, quite often the innova- tor will work with the value chain in determining which market approvals are necessary prior to launch,” he says. “This requires that an innovator invests time and money in research- ing the requirements for different marketplaces.” The cost involved in meeting all of those expectations can be extraordi- nary for biotech traits, which means it’s imperative for companies to know how to navigate the regulatory hur- dles so the investment can ultimately pay off. “The predictability and consist- ency of global regulatory approaches keeps every innovator up at night,” says Affleck. “They’re always taking