Millions of dollars and countless hours spent building public trust could be undone if Health Canada finalizes its proposed new regulatory guidance for products of gene editing (also called genome editing).
Despite biotechnology industry complaints that regulation is just red tape that hampers competitiveness, companies rely on the legitimacy that government regulation provides. If the proposed changes go ahead, unregulated — and even unreported — gene-edited products would come onto the market without a stamp of approval from Health Canada.
To be clear, what’s on the table is not a fast-track or light-touch approval process for gene editing. Health Canada is proposing a non-approval process that would allow product developers themselves to decide whether certain products are safe or if they need a review from Health Canada. These products would bypass Health Canada. Health Canada may not even know that these new products exist.
Canada does not regulate genetic engineering; it regulates “novel foods” and “plants with novel traits”. So far, all the genetically engineered foods eaten in Canada have been regulated as novel. While some gene-edited products may still fit the definition of novel, it’s likely that many will bypass the system.
Gene editing is powerful. It can open up new areas of the plant’s genome not accessible by conventional breeding.
Currently, gene editing relies on first-generation genetic engineering techniques to randomly insert genetic material that will produce a DNA “editing” system containing targeted gene cutters. The inserted material is then later (in most cases) bred out of the organism. Gene editing can efficiently send gene cutters to a target spot in the genome but they also regularly cut DNA at other places. This is just one of the ways that the editor is not precise. The entire process can leave behind unintended effects — and unintended genetic material — that need to be looked for and assessed for safety.
Yet Health Canada proposes that if foreign DNA has been removed from the organism, and if there is no other obvious novel characteristic, then safety assessment can be left to developers.
This is how Health Canada proposes to surrender its regulatory authority, by narrowing its definition of novel and thereby exempting a wide range of possible gene-edited plants.
Health Canada would consequently have no access to the science used by companies to determine safety. Health Canada would have no ability to require information from product developers, not even a notice of a gene-edited product heading to market.
To compensate for this gap, Health Canada also proposes a “voluntary transparency initiative” to “encourage” companies to voluntarily send the government a notice of any self-determined “non-novel” gene-edited product. This is a clear pathway for some unknown, unregulated gene-edited products to get to market.
Although the biotechnology industry is desperate to separate gene editing from genetically modified organisms in the public’s mind, there’s no way around the fact that gene editing is genetic engineering. That’s the science.
Even if gene editing can also be referred to as a tool of “plant breeding,” it remains genetic engineering. The biotech lobby’s argument that gene editing doesn’t warrant mandatory government assessments because it’s not very new or risky is not supported by science and much of the public is unlikely to accept it.
Canadians expect Health Canada to be an independent regulator on behalf of the public. However, these proposals reduce it to the status of bystander while the anticipated wave of foods from gene-edited plants enters our food system.
Asking Canadians to accept the safety assurance of product developers and rely on corporate co-operation is fuel for public mistrust.
The Canadian Biotechnology Action Network argues that it’s in the best interest of the public and the agriculture industry for Health Canada to retain regulatory authority over all genetically engineered foods, including those produced by gene editing. All gene-edited products need independent safety assessment.
Lucy Sharratt is the co-ordinator of the Canadian Biotechnology Action Network.