Health Canada Publishes Guidance for Industry on the Reporting of Incidents Involving Consumer Products

July 14, 2015

On July 8, 2015, Health Canada released important guidance designed to help consumer product companies, including retailers, understand their incident reporting obligations under the Canada Consumer Product Safety Act (CCPSA). Under section 14 of the CCPSA, “industry” must make a report to Health Canada when it becomes aware of a health or safety incident involving one of its consumer products. The new Health Canada publication – the Industry Guide on Mandatory Reporting under the Canada Consumer Product Safety Act – Section 14 “Duties in the Event of an Incident” (the “Guide”) – provides much-needed direction on a number of aspects of the incident reporting regime. For example:

  • How Health Canada defines “industry” (which was left undefined in the CCPSA itself) and its obligations under the CCPSA;
  • When an event constitutes an “incident” that must be reported;
  • At what point someone is “aware” of an incident;
  • When reporting of incidents must take place and what information should be included; and
  • How Health Canada will deal with confidential business information and personal information contained in an incident report.

Meaning of “Industry” under the CCPSA

The Guide states that, although there is no definition of “industry” in the CCPSA, sellers, importers, distributors and manufacturers are all subject to section 14 incident reporting obligations.

Meaning of “Incident” under the CCPSA

“Incident” is defined under section 14 of the CCPSA as:

  • An occurrence anywhere in the world,
  • A defect or characteristic, or
  • Incorrect, insufficient or missing label or instructions,

which resulted or may reasonably have been expected to result in death, serious injury or a serious adverse effect on someone’s health. In addition, a recall or any other measure instituted for human health or safety reasons by a foreign entity or a provincial government is also an “incident” for the purposes of the CCPSA.

Events vs. incidents

The Guide provides some additional information and context about incidents. In particular, it distinguishes between “events” and “incidents”. When industry learns about something that has occurred with any of its consumer products, this is called an “event.” Health Canada has stated that industry may receive information about events from product returns and complaints, product liability lawsuits or claims, directly from other levels of the supply chain, reports from experts, test reports, information from scientific or other studies, directly from governments (including Health Canada) or from bodies that set standards or certify products.

Upon becoming aware of an event, industry is obligated to determine whether the event constitutes an incident that must be reported. To do so, industry must determine whether the event meets one or more of the criteria in section 14 of the CCPSA (set out above). For the first three criteria, even if no injury occurred, industry must consider whether there was a reasonable potential for death or serious adverse health effects. Hazards should be considered from the viewpoint of the consumer, as opposed to those of product designers or engineers. The Guide provides further direction and examples for each of these criteria to illustrate circumstances where events may constitute incidents.

Serious adverse effects on health

The Guide states that a serious adverse effect on health includes a harmful effect that brings about a change to health. The change may be permanent or temporary. It includes damage to the body, chronic health effects, or any injury that sends a person to hospital or requires medical treatment. The Guide provides the following examples:

  • Threats to breathing such as choking, strangling, suffocation, asphyxiation, aspiration, or other respiratory problems;
  • External physical harm, such as a serious burn or cut;
  • Internal harm, such as internal bleeding, injury to an organ, broken bones;
  • Poisoning;
  • Allergic reactions (including anaphylaxis);
  • Loss of consciousness;
  • Convulsions; and
  • Loss of sight or hearing.

The seriousness of the injury or potential injury may depend on other factors, such as the person’s age and the part of the body that is harmed.

Cases of illegal usage or self-harm

While Health Canada states that it expects industry to report any death or serious injury related to a consumer product, it also states that illegal usage or self-harm may not necessarily constitute ”incidents”. However, should industry decide that a report is not required, it must have a strong case for doing so as it may be asked to explain its decision to a Health Canada Product Safety Officer.

Recalls in other jurisdictions

With respect to the fourth criterion of section 14, Health Canada clearly states that a recall in Canada or elsewhere for health or safety reasons is an incident that must be reported.

Reporting timeline

Under section 14(2) of the CCPSA, once a seller, distributor, importer or manufacturer is aware of an incident involving a consumer product, it has two days to provide a report to Health Canada that contains all the information about the incident within their control. This report must also be provided to the party from whom a seller, distributor or importer obtained the product. Section 14(3) of the CCPSA requires that importers and manufacturers provide Health Canada with an additional report within 10 days of the incident containing information about the incident and the product involved, and identifying other products that they import or manufacture that could be involved in a similar incident, as well as any measures they propose to take with respect to those products.

Entities with multiple roles in the supply chain

The Guide states that entities with multiple roles in the supply chain must report for only their highest role in the supply chain for that product. For example, manufacturers who also sell the product must report as manufacturers, which requires them to submit a section 14(3) report within 10 days of the incident.

What constitutes “Awareness” of an incident?

Health Canada has clarified that “awareness” of an incident does not mean that industry needs to be fully certain of all aspects or details of an event. Even if industry is not certain whether an incident occurred, it should report to Health Canada on a precautionary basis. Once it has been determined that an incident has occurred, awareness is established.

Awareness does not require certainty: timely reporting is essential

The Guide explicitly states that industry should not wait until further details are received or until there is absolute certainty that an incident has occurred (for example, through a formal risk assessment). The Guide states that in most cases, by the time a company is considering a recall or announcement about a product for health or safety reasons it should already have submitted an incident report to Health Canada and that failure to report an incident in a timely manner is an offence under the CCPSA. This has important implications as the CCPSA provides that all incident must be reported within two days of industry becoming aware of an incident. In order to avoid a potential offence under the CCPSA, industry should consider whether to report events that may potentially be incidents on a precautionary basis (the Guide notes that industry can update Health Canada if it is later determined that an event that was reported is not an incident). A person convicted of an offence under the CCPSA is liable to a fine or to imprisonment, or both depending on the nature and circumstances of the offence.

Reporting of Incidents

The Guide also provides direction as to the manner and content of incident reports under sections 14(2) and 14(3) of the CCPSA and the timing for their submission (Health Canada strongly encourages use of its incident report form available on its website). The Guide sets out the type of information that should be included in a Section 14(2) report:

  • All information about the product (name, model number, UPC, serial number)
  • A description of how the incident happened;
  • Detail of injuries (body part, age of victim, kind of treatment they needed)
  • Details on where the product is sold;
  • Complete name and contact information of the manufacturer or importer, as it appears on the product label;
  • Complete name and contact information of who supplied the product to you
  • Information on any other known events related to the product;
  • Information on any other known incidents with this product reported in the past to Health Canada; and
  • Information on products that share the same parts (components) as the one involved in the incident.

For manufacturers of the consumer product (or the importer, if the manufacturer carries on business outside Canada) who are required to make a section 14(3) report within 10 days of becoming aware of an incident, the Guide states that this report would usually include:

  • New details about the incident gathered from the consumer or through examination of the product involved in the incident (such as the root cause).
  • More information about the product, such as:
    • the number of products distributed
    • other incidents related to the same or similar product, with numbers of products distributed and a description
    • standards to which the product is certified and any Canadian Certification Records that exist
    • test reports, if you did testing on the product or similar products
    • warning labels and instructions on the product
    • pictures and diagrams of the product, as needed
    • steps the company took or will take to ensure safety
  • Other products that may be affected (such as products that share the same component involved in the incident).
  • Information about corrective action, including:
    • proposed corrective action(s) and an explanation of how the corrective measure will address the issue, or
    • the reasons corrective actions are not needed.

Corrective actions may include consumer advisories, voluntary recall of the product, design changes, stopping sale or distribution, product correction, and design or materials changes, among others. Additionally, the Guide provides that not every section 14(3) report will need to state corrective actions. If industry decides that no action is required in response to the incident, it should be prepared to explain its reasoning to Health Canada and update Health Canada as it learns more over time.

Extensions of time

If a manufacturer or importer expects they will not be able to file a section 14(3) report within 10 days, they must request an extension from Health Canada well before the deadline for the report. The Guide also states that Health Canada encourages reports from industry about events that have been determined not to be incidents. This report should contain clear reasons for the decision as to why the event is not an incident under the CCPSA.

Confidential Business Information and Personal Information

Under the CCPSA, Health Canada may disclose confidential business information (CBI) in order to protect human health or safety, or the environment, without the consent of, or prior notice to, the person (or establishment) if certain conditions are met. The Minister may disclose CBI to the public without the consent of, or prior notice to, the person if a consumer product poses a serious and imminent danger to human health or safety, or to the environment, if disclosing the CBI is essential to addressing the danger.

The Guide states that: “It is often possible to deal with health or safety concerns without disclosing CBI. Health Canada will consider relevant factors when determining whether to disclose CBI in a particular case.”

The Guide also advises that Health Canada does not routinely require personal information when it assesses incident reports submitted under section 14. The Privacy Act (Canada) applies to Health Canada and will govern how it manages any personal information that is submitted. The Guide also states that industry must comply with all laws that normally apply to the disclosure of personal information and that when in doubt, industry should omit personal information about a consumer. If Health Canada requires personal information about a consumer in a specific case in order to follow up on a section 14 report, Health Canada will request the information.

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