Frequently Asked Questions: AquAdvantage Salmon
The Government of Canada has determined that the genetically modified AquAdvantage Salmon is as safe and nutritious for humans and livestock as conventional salmon. In Canada, novel products are only authorized once regulators are satisfied that every aspect of the assessments has been adequately addressed.
AquAdvantage Salmon required three separate assessments. Health Canada assessed the safety and nutrition of AquAdvantage Salmon for use as food, the Canadian Food Inspection Agency (CFIA) assessed the safety and nutrition of AquAdvantage Salmon for use as a livestock feed and Environment and Climate Change Canada (ECCC) assessed the risk to the environment.
Q1. What is a genetically modified food?
A GM food is one derived from an organism that has had some of its heritable traits changed. This can involve:
- Traditional techniques of crossbreeding;
- Using chemicals or radiation to alter the genetic make-up of the organism's cells in a process called mutagenesis; or
- Applying recombinant DNA or genetic engineering techniques - for instance, introducing a gene from one species into another species.
Before a new agricultural or food product can be produced and marketed, it is subjected to thorough safety assessments to protect humans, animals and the environment. The government categorizes genetically modified products as "novel" products. This term covers products that have not been previously available for sale in Canada, or are produced by a new process, such as genetic engineering.
A company typically takes seven to ten years to research, develop and test a novel food before filing a pre-market notification with the Food Directorate of Health Canada to obtain approval for sale.
Q2. What is the process for approving genetically modified food?
It typically takes a company seven to ten years to research, develop and test a GM food before it has compiled enough data to submit an application for market access to the Government of Canada. The company is required to submit detailed information to Health Canada outlining exactly how the product was developed. This information is reviewed by Health Canada scientists with expertise in areas such as molecular biology, toxicology, chemistry, nutritional sciences and microbiology.
In evaluating the safety of a GM food, Health Canada looks at:
- How the modified product was developed, including genetic changes that were made to any plant, animal or microorganism used in the product;
- How the GM food compares to its non-modified counterpart in terms of composition (e.g., fats, proteins and carbohydrates) and nutrition quality;
- The potential for production of new toxins in the food;
- The potential for causing allergic reactions; and
- The microbiological and chemical safety of the food.
No GM food is allowed on the Canadian market unless Health Canada's scientists are satisfied that the food is safe and nutritious.
Q3. What is AquAdvantage Salmon?
AquAdvantage Salmon is a genetically modified salmon developed by AquaBounty Technologies Inc. to promote rapid growth during early life. This was achieved by adding a growth hormone gene from the Chinook salmon to an Atlantic salmon.
Q4. What is the process for approving a genetically modified livestock feed?
The CFIA evaluates and regulates all feed ingredients, including novel feeds derived from GM organisms, in the same manner as food assessments. Any feed ingredient that is new, or has been modified such that it differs significantly from a conventional ingredient, is required to undergo a pre-market assessment and approval before being allowed on the Canadian market. The purpose of all feed assessments is the same: to ensure, prior to marketing, that the feed ingredient is safe in terms of animal health, human health via food residues and worker/by-stander exposure, and the environment. The assessment also ensures the feed ingredient is effective for its intended purpose. The assessment ensures that the feed is accurately defined in the Feeds Regulations and is labelled appropriately for its safe, effective use and for consumer protection.
Q5. What data were used for the genetically modified livestock feed assessments?
As part of the assessment process, AquaBounty Technologies Inc. provided extensive data for review by regulators at the CFIA. The submitted data included a detailed description of how AquAdvantage Salmon was developed, how the rapid growth during early life trait functions and nutritional composition of the fish. Regulators also accessed relevant peer-reviewed studies from the published literature.
Canada's regulatory framework requires the product developer to generate the data necessary to fulfil the requirements of the safety and nutrition assessments. This approach to data generation is consistent with that of regulatory bodies around the world for products of biotechnology and other types of products such as drugs.
Q6. What are the federal government's guidelines on labelling of genetically modified foods?
Health Canada and the CFIA share the federal responsibility for food labelling under the Food and Drugs Act. Health Canada is responsible for food labelling policies with respect to health and safety. Health Canada requires labelling for food products, including genetically modified foods, where clear, scientifically established health risks or significant nutritional changes have been identified that can be mitigated through labelling. For example, an allergen present in a food must be labelled to alert consumers.
In Canada, there is a national voluntary labelling standard for genetically engineered foods (one method of genetic modification). The Voluntary Labelling and Advertising of Foods that Are and Are not Products of Genetic Engineering was first adopted by the Standards Council of Canada in April 2004. It provides guidance to food manufacturers on how to make claims regarding genetically engineered foods that are in compliance with the labelling requirements of the Food and Drugs Act. The CFIA is responsible for enforcing these labelling requirements.
Q7. Will foods containing AquAdvantage Salmon be labelled?
In Canada, voluntary labelling is permitted to provide consumers with information that is not related to the safety of the product. The national standard, "Voluntary Labelling and Advertising of Foods that Are and Are Not Products of Genetic Engineering", states that products can be voluntarily labelled as GE or non-GE, provided conditions are met and the claim is understandable, informative, accurate, and not misleading.
The decision of whether or not to proceed with voluntary labelling is that of AquaBounty Technologies Inc.
Q8. How can I tell if a food has been genetically modified?
Consumers who wish to know if their foods are derived or contain an ingredient from a genetically modified source may choose foods that have been labelled according to the national standard for Voluntary Labelling and Advertising of Foods that Are and Are not Products of Genetic Engineering. For example, a food may claim that it is "non-genetically engineered" if other similar foods exist that are genetically modified. If consumers have questions about the method of production of the food, they can directly contact the manufacturer or inquire at the point of sale.
Q9. Are there long-term health impacts of eating genetically modified salmon and other genetically modified foods?
Scientists have assessed and concluded that genetically modified foods allowed on the Canadian market are as safe to eat as their conventional counterparts. In fact, genetically modified foods are subject to a far higher level of regulatory oversight and of scientific requirements than traditionally bred plants and animals. Each new GM food is subject to a thorough and robust safety assessment before it is allowed on the Canadian market.
As is the case with any food or health product, it is Health Canada's mandate to monitor potential long-term health trends associated with exposure to a breadth of product areas - including but not limited to - GM foods. Since genetic modification does not introduce unique risks, the potential for long term effects of these foods are no different than that for conventional foods which have been safely part of the Canadian diet for a long time. Health Canada has found that AquAdvantage Salmon is as safe to eat and as nutritious as conventional salmon. Therefore, there is no current evidence to indicate that long-term studies are needed to ensure the safety of foods produced using this technology.
Q10. Were effects on Canada's salmon industry considered?
The Government of Canada will only authorize a product for use as food and livestock feed if, after a thorough scientific assessment, it is determined to be as safe as its conventional counterparts. In order to protect the scientific integrity of the assessment process, socio-economic factors, such as potential market reaction, are not considered in the decision-making process with respect to novel products.
In Canada, once a novel product, such as AquAdvantage Salmon, has been approved for use as food and livestock feed, it is considered to be equivalent to its conventional counterparts. Producers are free to choose amongst products deemed to be safe and to implement the production methods and marketing strategies of their choice. Similarly, the Government of Canada supports consumer choice, and strives to provide consumers with access to meaningful, credible, and truthful information as it relates to biotechnology and food.
Q11. Will CFIA inspect the production facility?
CFIA veterinarians, under the National Aquatic Animal Health Program, ensure that the facility complies with requirements for the domestic and international movement of products.
In addition, Environment and Climate Change Canada's enforcement officers have conducted inspections of the facility where AquAdvantage Salmon are being produced, and have not found evidence of any violations to the New Substances Notification Regulations (Organisms).
Q12. Will GM salmon be in Canadian products exported to other markets?
Health Canada and the Canadian Food Inspection Agency approved GM salmon to be used as food or livestock feed in Canada. In the event that a Canadian company chooses to export GM salmon in any form to another country, the exporter would need to comply with the importing country's regulatory requirements, including any related to GM products.
Q13. Does the Government of Canada endorse AquAdvantage Salmon?
The Government of Canada neither advocates for, nor opposes, specific products. Regulatory decisions are evidence-based and impartial.
Q14. Is Canada the only country to approve AquAdvantage Salmon?
Canada is not the first country to approve this product for use as food and livestock feed. In November 2015, the AquAdvantage Salmon was approved by the United States Food and Drug Administration following the Agency's scientific safety review.
Q15. Where can I find additional information on the assessment of genetically modified foods in Canada?
More information regarding the assessment of genetically modified foods in Canada and Health Canada's role can be found at: Factsheets & Frequently Asked Questions
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