Overview of Health Canada's Consumer Product Safety Program Risk Characterization Method

Health Canada's Consumer Product Safety Program (the Program) identifies, assesses, manages, and communicates risks to human health or safety of consumer products^{Footnote 1} and cosmetics^{Footnote 2} after they reach the consumer market. To do this, the Program applies a risk-based approach to setting priorities and carrying out risk assessment work. This means that priority is given to product safety issues with the greatest potential for posing a risk to human health or safety. Risk is defined as the combination of the severity of a potential health hazard and the likelihood this will occur. The Program's risk assessment approach follows the principles and processes outlined in its Risk Assessment Framework

In many cases, a preliminary evaluation will identify the hazards and safety concerns associated with a consumer product, and often this is sufficient for the Program to manage the risk. In other cases, for example when the hazard is complex or when an entire category of products is involved, the Program may conduct a more in-depth risk assessment. In these cases, when warranted, both the severity and likelihood are formally evaluated to create a "risk characterization", as set out below.

The Risk Characterization Method:

• identifies an overall risk level (Very High, High, Medium, Low) for a consumer product or cosmetic based on how severe an injury could be and how likely it is that an injury will happen;
• uses the same scale to evaluate different types of hazards (hazards can include mechanical, physical, electrical, flammability and toxicological hazards).

Goals and guiding principles

The method is based on these guiding principles:

• Transparency: The method is documented and aims to be objective and systematic. It leads to results that can be easily understood by a variety of stakeholders.
• Consistency: The method uses data in a consistent way and on the same scale for all types of hazards being assessed.
• Flexibility: The method gives options in cases where some data is missing. This balances the need for precision with the need to provide timely risk assessments.

Basic concepts that apply to the Risk Characterization Method

Risk is measured by combining the level of harm that a consumer product or cosmetic can cause with the likelihood the harm will occur. In the Risk Characterization Method, the level of harm is called injury severity and the chance of this harm happening is called likelihood of injury.

There are two kinds of risks from consumer products or cosmetics: 1) The risk to actual users of the product (user risk) and 2) the risk to people in the population of interest (population risk). For example, if we want to assess the risk of injury for a children's toy of a specific brand and model:

1. The user risk is the risk that a child that has access to the product will be injured while playing with the toy.
2. The population risk is the risk that a child in the population of interest (such as children in Canada aged 3 years or younger) will be injured by the product. The population risk will be lower than the user risk because a portion of children in the population may not have access to this product.

Risk varies based on the population being assessed. Risk can be characterized for a population that includes all intended users, or it can be characterized for a sub-set of this population based on factors like vulnerability to the hazard, usage type, etc. For example, the risks linked to children's jewellery that contains lead will be higher for children less than 3 years old because these children are more likely to put jewellery in their mouths. In the Risk Characterization Method, the population that the Consumer Product Safety Program chooses to assess is based on who is most likely to be affected by the product hazard.

Details of the Risk Characterization Method

Context: The method uses the following information:

• Scope: Describes the product, the hazard, the type of use (intended and non-intended), and the population of interest.
• Pathway(s) to injury: Describes all of the events that need to occur for a person to sustain an injury caused by the cosmetic or consumer product. A risk assessment may need to deal with more than one pathway to injury, which means that the risk characterization may create more than one user risk and more than one population risk.
• Available data: Provides incident or probability data, the number of people within the population of interest, and the number of actual users within that population.

The injury severity is determined using a scale of 5 severity levels: (1) Minor, (2) Moderate, (3) Severe, (4) Life-threatening or Disabling, and (5) Fatal. The Consumer Product Safety Program has developed internal processes to guide decision making about injury severity.

The likelihood of injury for users and for the population of interest is determined using a 6 level scale: (1) Extremely Rare, (2) Rare, (3) Unusual, (4) Occasional, (5) Common, and (6) Frequent. The Consumer Product Safety Program uses two methods to determine the injury likelihood level:

1. Semi-quantitative method: This method uses data to determine a specific injury rate or probability.
2. Qualitative method: This method uses a scoring approach based on a set of statements about factors that contribute to the risk. This method is only used in cases where there is not enough data to use the semi-quantitative Method.

The risk level is determined using a matrix that combines Injury Severity and Likelihood of Injury. Risk levels are set at: Very High, High, Medium, and Low.

The Consumer Product Safety Program understands that the quality of data available will vary from case to case. That's why it is important to consider the quality of the data used when we reach conclusions based on that data. The Risk Characterization Method has an uncertainty analysis as a standard feature. It rates the uncertainty of data source(s) and of the overall user and population risk levels.

In summary, Health Canada's Consumer Product Safety Program applies a transparent, consistent and flexible approach to characterizing risks. The Risk Characterization Method supports the principles and processes outlined in the Program's Risk Assessment Framework. Risk assessments inform risk management actions which could result in the application of a range of different tools such as enforcement, regulation, outreach, or monitoring. For a copy of the full Consumer Product Safety Program Risk Assessment Framework or Risk Characterization Method, please contact: cps-spc@hc-sc.gc.ca