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Canada showed foresight with GMO policy
Jun. 6, 2016
It’s about 25 years since genetically modified organisms (GMOs), one of the first products of biotechnology, were commercialized, and they remain controversial to this day.
Governments the world over developed policies for assessing and regulating them. Most developed their policies based on whether the plant or animal was a transgenic — containing foreign genetic material inserted by artificial means.
Canada took a different approach. Rather than regulate the process, it opted to regulate whether plants contain a novel trait. Of course, that includes GMOs, but it also applies to traits developed through conventional plant breeding as well.
Despite its complicated name, "clustered regularly interspaced short palindromic repeats" (CRISPR/Cas9) dramatically simplifies the gene-editing process. Likened to a "search and replace" function for genes, it is touted as a scientific breakthrough that is perhaps even more important than transgenics because of its ability to work within the existing genetic code.
Scientists believe they can use the technique to alter the reproductive ability of malaria-carrying mosquitoes, produce disease-resistant pigs and develop crops that are more resilient to pests and environmental stressors. It is also seen as reshaping the world of biomedical research.
"We’ve never been able to go in and make such a precise change as we can now with gene editing," Wendy Harwood, a John Innes Centre scientist based in Norwich, England, told Reuters. "This gives you exactly the change you want without anything you don’t want."
Predictably, this ability has opened a Pandora’s box of commercial, ethical and regulatory concerns. There is a bitter dispute unfolding in the U.S. over who discovered it first, a key question for staking out patent claims.
And what about unintended consequences? If scientists develop the ability to virtually eliminate the mosquito by turning off the female’s ability to reproduce, how does nature fill the gap in the ecosystem? And how far do you take this when it comes to programming, for example, disease out of the human genetic code? And how do you regulate it?
The U.S. doesn’t, at least for now. Regulatory authorities waved through the first plant developed using CRISPR/Cas-9 earlier this year, a button mushroom that doesn’t brown. But that isn’t sitting well with groups concerned about the potential impacts of this technology. The U.S. government has announced a review.
The European Union, which has never fully embraced GMOs, is equally contorted, with organizations such as Greenpeace lobbying to have it regulated as a "new breeding technique" and the companies using the technology countering that it isn’t much different than what occurs naturally. The uncertainty is affecting researchers’ ability to source funds.
However, the Canadian Food Inspection Agency has confirmed plants modified using CRISPR/Cas-9 are considered "novel" and therefore won’t be sailing past regulatory scrutiny in Canada.
While the U.S. regulatory system has so far determined plants developed using CRISPR are not GMOs and therefore do not fall under the regulatory process, Canada’s much broader approach leaves it well-positioned to review it.
"In Canada, the approach to the regulatory oversight is based on the novelty of the product rather than the means of development," said Cindy Pearson, national manager of the Plant Biosafety Office with the Canadian Food Inspection Agency.
"If there is a new trait in there, then it would trigger the need for a pre-market assessment."
That means they will be reviewed by Health Canada for their safety as a food and by the CFIA for environmental safety and use as livestock feed before they can be commercialized.
To date, no applications for plants developed using the technique have come forward in this country.
The significance — and the wisdom — of Canada’s unique policy development a quarter-century ago is now the envy of scientists elsewhere. Policy-makers involved with that process realized GMOs weren’t the destination, they were merely a gateway.
Source: Winnipeg Free Press
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