In an attempt to keep benign crops from getting tangled up in regulations primarily designed for products of biotechnology, the Canadian Food Inspection Agency is revamping its definition of plants with novel traits.
The move comes at the behest of angry plant breeders who complain that confusion over the definition makes an already lousy regulation even worse.
Bruce Coulman, acting director of the University of Saskatchewan’s Crop Development Centre, said the existing regulations handcuff Canadian breeders and prevent farmers from gaining access to innovative new crops.
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“The majority of other countries only regulate transgenes or GMOs,” he said.
Canada regulates anything novel, even crops created using conventional breeding techniques.
“We consider this something that discourages innovation,” said Coulman.
Had canola been developed under the existing rules, it would have been deemed a novel crop and may never have been commercialized due to the extra costs and red tape involved in getting it to market, he said.
Another example of how Canada’s rules stifle innovation is that new varieties that yield more than 10 percent over control varieties are considered novel and are subject to regulation, said Coulman.
“One has to question what possible harm could this cause to the environment?”
The situation has become so frustrating for crop developers that one of the senior breeders at the Crop Development Centre has threatened to quit his job if the government doesn’t address breeders’ concerns.
In addition to objecting to a regulation that goes beyond monitoring the development of biotech crops, breeders are annoyed by the vagaries surrounding the definition of plants with novel traits.
“Right now there is a lot of confusion as to what really constitutes a novel trait,” said Coulman.
The definition enshrined in the Seeds Act comprises two components – the plant has to contain a trait not present in the Canadian population of that species and that trait must pose a potential threat to environmental safety.
“It has been a bit of a complicated definition,” said Kirsten Finstad, acting national manager of the CFIA’s Plant Biosafety Office.
Officials at the CFIA have focused on the first part of the definition when deeming whether a new variety should fall under regulations.
“This has led to a lot of ambiguity and a lot of concern among plant breeders,” said Finstad.
The National Forum on Seed, a seed industry lobby group, has asked the CFIA to develop a new guidance document that better informs breeders which of their projects will likely trigger the novelty designation.
Instead of placing emphasis on what is a new development, the CFIA will attempt to provide direction on those new traits it feels are more likely to have a negative impact on environment or food safety.
It hopes the guidelines will avoid stifling creativity in crop development, while maintaining safeguards for protecting the environment from potentially harmful strains coming out of laboratories around the country.
Finstad said the old guidelines have been more of a psychological barrier than a physical one. She can think of few instances where the rules snagged the wrong type of crop.
“It’s more of a concern about what might happen than what has happened.”
Coulman said that’s not true. He said the threat is real, citing the recent case of a barley variety that has been refused registration in Canada because it was deemed novel. Meanwhile, a U.S. barley variety with the same traits had no problem receiving registration in that country.
“We’re not very happy about that,” he said.
Coulman said the CFIA is taking a step in the right direction by revamping its definition of plants with novel traits, but he would rather see it go one step further and scrap the system altogether, replacing it with a regulation solely governing the development of biotech crops.
A draft version of the new guidance document will be available for industry comment in November. The final version will be implemented some time in 2007.
