Canada applies a risk-based regulatory approach to both GMOs and genome edited plants, that is triggered by ‘novelty’ and based on a rather complex biotechnology-related regulatory oversight consisting of no fewer than eight acts and policies, administered by eight agencies, pertaining to the different aspects of biotechnology products on the Canadian market (see the table below).

Table: Overview of regulatory agencies, products and regulations pertaining to GMOs and genome edited plants in Canada (ECCC (Environment & Climate Change Canada), DFO (Fisheries & Oceans Canada), AAFC (Agriculture & Agri-Food Canada), GAC (Global Affairs Canada), ISED (Innovation, Science & Economic Development Canada) (source: (Friedrichs, et al.)).

The complexity of the Canadian model is afforded by the country’s effort to use existing acts and regulations rather than developing any new regulation, when new breeding methodologies had started to be increasingly used in the 1980s and 1990s (Friedrichs, et al.).

Genetically Modified and Genome Edited Plants

The Canadian regulatory approach relies on the assumption that ‘since there are many paths to the same result, the consistent and risk-based regulatory approach is to regulate products, not processes’; it requires a pre-market safety-assessment based on a categorisation into one of two groups only (Friedrichs, et al.): 

1. pre-market safety assessment for agriculture biotechnology products, including products produced through genome editing, only if they were novel (i.e. express a new characteristic) and could therefore pose a new risk, and
2. no pre-market safety assessment for genome edited products that did not express a novel trait (i.e. “novel” meant “novel to the Canadian environment, or the food or feed supply in Canada”).

Throughout the assessment, the Canadian regulatory process is considered risk-based, in that the responsible governmental agencies have flexible information requirements that are (a) not prescriptive, (b) case-specific, and (c) outcome-based; proponents are explicitly encouraged to contact the regulatory authorities early in the product development process, in order to discuss both the potential regulatory requirements (pre-submission consultations), and the novelty determination. The environmental safety of novel plants is assessed with regard to (a) potential for weediness, (b) consequences of gene flow, (c) potential to become a plant pest, (d) impact on non-target organisms, and (e) and impact on biodiversity (Friedrichs, et al.).

Genetically Modified and Genome Edited Animals

Genetically modified animals are regulated under the Canadian Environmental Protection Act for potential environmental or indirect human health concerns; no specific genome editing policy is currently in place for genome edited animals, but several inquiries had been received, and the relevant authority is currently preparing to examine the resulting organisms for genetic changes on a case-by-case basis (Friedrichs, et al.).