As previously reported at the consultation stage, Health Canada has completed its process of developing a Risk Assessment Framework (the Framework) prepared for the Consumer Product Safety Program (the Program).

The Consumer Product Safety Program

The Program is responsible for the administration and application of legislative requirements pertaining to consumer products and cosmetics after they reach the consumer market; in accordance with that mandate, the Program identifies, assesses, manages, and communicates risks to human health or safety posed by these products in Canada.

The Risk Assessment Framework

The Framework is proposed to provide clarity and transparency on the principles and processes associated with risk assessment in the Program and how the Program will focus its attention.

The Framework acknowledges that risk assessment is not carried out in all situations and describes a number of factors that will be addressed in deciding whether or not a risk assessment is needed, including (for example), the possible severity of an actual or potential injury, the age of the person who could be affected (e.g., whether children are exposed to potential injury), and whether it is reasonable to attribute the injury, if any, to the use of a product. According to the Framework, if a risk assessment is in fact carried out, the goal will be to identify and characterize the various properties of the potential hazard and the link between the hazard and reported health outcomes; estimate the likelihood that the hazard will materialize when the consumer uses the product; and make a determination on the overall risk with the product given the hazard and likelihood that the hazard will occur.

In gathering information for the purpose of a risk assessment, the Framework provides that the Program may consult subject-matter experts within or outside of government. Manufacturers and importers may provide, or in some cases may be required to provide, information to inform the steps in the risk assessment process of their product. They may also be given an opportunity to review the risk assessment report, where appropriate in the circumstances of specific cases. All of this information will be considered by risk management officials who will consider the risk assessment, among other considerations, to determine how to respond to the issue.

The Framework states that the overall goal of the Program will be to carry out risk assessments in a manner that is “consistent, systematic, structured and based on the best available evidence”, and that risk assessment activities will be guided by the following principles:

  1. The priority and level of effort given to conducting a risk assessment will be determined by the potential risk to health or safety.
  2. A risk assessment will be based on evidence and professional judgement.
  3. The risk assessment process will be as transparent as possible.
  4. A risk assessment will identify uncertainties.
  5. A risk assessment will consider population variability and vulnerability.
  6. A risk assessment will consider foreseeable use and foreseeable misuse of a product.

Health Canada’s summary of the Framework describes these principles and how they may be applied in practice in more detail.

Interested parties may obtain a copy of the full Risk Assessment Framework from the Consumer Product Safety Directorate (Health Canada) by email at CCPSA-LCSPC@hc-sc.gc.ca.