Questions and Answers - Management of Unauthorized Plant Products Derived through Biotechnology

Q.1 What are "unauthorized plant products derived through biotechnology"?

A.1 Unauthorized plant products derived through biotechnology are those that would normally trigger food, feed or environmental safety assessments if they were meant to be used or released in Canada, but have not received the required authorizations from Health Canada and/or the Canadian Food Inspection Agency (CFIA).

Being unauthorized does not mean that a product is unsafe. It means the product has not been assessed, therefore its safety is unknown. However, the presence of an unauthorized plant product derived through biotechnology in the Canadian food or feed supply or environment violates Canadian regulations regardless of whether there are potential safety concerns.

Q.2 What conditions are imposed on plant products derived through biotechnology before they receive food, livestock feed and environmental safety approvals in Canada?

A.2 In Canada, novel plant products derived through biotechnology must be contained (in a laboratory or a greenhouse) until they receive all required food, feed and environmental safety approvals.

Experimental lines of novel genetically modified crops cannot be planted outside of containment unless they are in confined field trials that are authorized and inspected by the CFIA.

The CFIA sets and enforces strict conditions on confined field trials. This minimizes any impact the plants may have on the environment. Some of these conditions include the following:

  • No harvested material or byproduct from a confined research field trial may be used as human food or livestock feed without prior approval of Health Canada or the CFIA, respectively.
  • Field trials are inspected regularly in order to determine if the terms and conditions imposed by the CFIA are adhered to. The trial locations are monitored even after completion of the trial.

For more information on the regulation of plant products derived through biotechnology and confined research field trials, see the following factsheets:

Q.3 Have unauthorized plant products derived through biotechnology ever been found outside of containment in Canada?

A.3 While it is very rare, unauthorized plant products derived through biotechnology have been found outside of contained and confined conditions, either from Canadian sources or in imports from other countries.

Even though the CFIA and Health Canada have not identified health or environmental safety concerns associated with these incidents, such occurrences do contravene Canadian legislation. The specific act or regulation contravened depends on the type of product and the circumstances of the release.

Canadian legislation that may apply in such instances includes:

  • The Food and Drugs Act
  • The Consumer Packaging and Labelling Act
  • The Feeds Act
  • The Seeds Act
  • The Plant Protection Act
  • The Canada Grain Act

Q.4 How does the CFIA respond when an unauthorized plant product is found in Canada?

A.4 When the CFIA becomes aware of an unauthorized plant product in the environment or marketplace, it begins a risk management plan intended to mitigate potential impacts on human health, livestock health and the environment.

This plan may include actions such as product recalls to remove the product from the Canadian marketplace or control measures being put in place to prevent further imports of the product.

Risk management decisions are based on several factors. The most essential one is the conclusion of a risk assessment. Risk assessment is a process done by Health Canada and/or the CFIA to determine the risk to the safety of the Canadian public, livestock, and environment.

Q.5 What type of information is used in a risk assessment?

A.5 Risk assessors from Health Canada and the CFIA look for information about the hazards to human health, animal health and the environment posed by an unauthorized product. They also look for information about the prevalence and distribution of the product in question and use this information to determine the level of exposure to humans, animals and the environment, and the risks of such a level of exposure.

With regard to human and animal safety, the main goal of the risk assessment is to find out if the product is toxic or allergenic.

With regard to environmental safety, the risk assessment considers:

  • the biology of the plant species and its ability to persist in Canada's environment;
  • the novel trait; and,
  • any other available data to decide if the plant could cause harm to Canada's environment.

The risk assessment process is an ongoing one. Any additional information gathered after the initial assessment is done will be considered to verify the conclusions's accuracy.

Q.6 What types of risk management actions can the CFIA use when responding to the presence of an unauthorized plant product derived through biotechnology?

A.6 The actions that the CFIA takes as part of a risk management plan depend on the conclusions reached in the risk assessment. Such actions are decided on a case-by-case basis. The risk management of unauthorized plant products derived through biotechnology is no different from that of other products not derived through biotechnology. The goal is to have the situation brought back into compliance.

To enforce the regulations, the CFIA may take actions such as:

  • sending warning letters;
  • pulling products from the market;
  • monitoring the border;
  • issuing fines; and/or,
  • taking legal actions against the offending parties.

For more information on how the CFIA manages instances of unauthorized plant products derived through biotechnology found outside of containment, please refer to the fact sheet "How Does the CFIA Manage Cases of Non-compliance of Unauthorized Plant Products Derived through Biotechnology?"