Thank you, Mr. Chairman, for the opportunity to speak with you this morning about Health Canada's role in regulating genetically modified foods, including GM animals intended for human consumption in Canada.
Health Canada's mission is to help Canadians maintain and improve their health. In order to fulfill its mission, Health Canada develops appropriate regulatory frameworks and guidance to help ensure that the food products Canadians purchase are safe and nutritious.
Within Health Canada, the food directorate is the federal authority responsible for establishing policies, setting standards, and providing authoritative advice and information on the safety and nutritional value of all food sold in Canada. In support of this role, the food directorate conducts scientific research as well as health risk and benefit assessments. We also conduct pre-market reviews for products including food additives, infant formula, and novel foods.
In the 1990s, Health Canada established new regulations under division 28, part B, of the Food and Drug Regulations, also known as the novel foods regulations. These regulations capture any GM micro-organisms, plant or animal, and require food companies to notify the department prior to making them available for sale in the Canadian marketplace. This allows Health Canada to determine that the product is safe for use as a food.
To support the pre-market safety assessment process, the company wishing to sell the product must submit detailed scientific data to support the safety and nutritional value of the genetically modified food. Only once Health Canada is satisfied that the data provided demonstrates that the food is safe and nutritious will it be allowed for sale on the Canadian market.
These regulations address any new GM product because they are triggered by the addition or change in a trait of a product as opposed to the technology used to produce it. In order to evaluate the safety of GM foods for food use, whether a GM crop or a GM animal, Health Canada uses a rigorous process that is consistent with internationally established scientific principles and guidelines developed through the work of the Organisation for Economic Co-operation and Development, the Food and Agriculture Organization, the World Health Organization, and the Codex Alimentarius Commission.
This assessment is conducted by Health Canada scientific evaluators, who have expertise in molecular biology, toxicology, chemistry, nutritional sciences and microbiology. They review how the food was developed, compare its compositional and nutritional profile with conventional counterparts, and look at the potential for the food to be toxic or to contain a toxin or allergen.
If in any area of the assessment Health Canada scientists determine that the data provided is not sufficient, additional information and/or testing would be required and requested in order to fully demonstrate the safety of that product. Only when all the scientists evaluating a GM food agree that there are no safety concerns is the food permitted into the Canadian marketplace.
It should also be noted that Health Canada scientists also consider other published data, in addition to that provided by the company, that is relevant to the product in question when it is completing the safety assessment.
Under the current regulatory framework approval, no single government body is responsible for making a final decision on these products. Health Canada, the Canadian Food Inspection Agency, and Environment and Climate Change Canada all have a role to play in the overall approval process that allows for a GM food to enter the Canadian marketplace.
While each department or agency makes its own independent decisions regarding the authorization of a GM food according to its own regulatory authorities, Health Canada and the CFIA have a “no split” approval policy that ensures the coordinated communication of positive decisions. This is aimed to prevent unapproved GM foods, feeds, or seeds from entering the Canadian marketplace.
Historically, most GM food submissions have been related to foods derived from GM crops. However, Health Canada and the CFIA did receive a GM food submission from AquaBounty for its GM salmon. This product was modified using recombinant DNA technology to grow faster and thus reach market weight sooner than a non-modified farmed Atlantic salmon. This was the first submission for approval of a GM animal for food and animal feed use in Canada.
In May 2016, Health Canada and the CFIA completed thorough and rigorous scientific reviews of the AquAdvantage salmon and determined that it was as safe and nutritious for humans and livestock as conventional salmon is. This completed the Government of Canada's scientific safety assessments required to let AquAdvantage salmon be allowed for use as food.
Under the Food and Drugs Act, Health Canada requires mandatory labelling for any food, including food derived from genetic modification, when there is a health risk or significant nutritional changes to the food that can be mitigated through labelling. In these situations, labelling is required to alert consumers or susceptible populations. Given that the GM salmon was determined to be safe and nutritious, there are no special labelling requirements.
As my colleague from CFIA has already noted, voluntary labelling is permitted to provide consumers with information that is not related to the safety of the product. The national voluntary standard allows companies to voluntarily label foods as GE or non-GE. Voluntary labelling is a marketing issue and does not fall under the mandate of Health Canada, which is related to food safety only.
We are also committed to ensuring openness and transparency in our evidence-based decision-making. So, to help inform Canadians on the regulatory decisions related to novel foods, including GM foods, Health Canada posts detailed decision documents along with plain language summaries of the safety assessment on our website.
I hope that the activities I have highlighted today help explain the science-based approach that Health Canada takes to regulating novel foods and, in particular, those that are products of genetic modification.
Thank you for your time today.
Thank you.