Consumer Product Enforcement Summary Report - Cyclical Enforcement Project 2018-2019: Mandatory Reporting
Fiscal Year 2018-2019
The Consumer Product Safety Program (CPSP) of Health Canada administers and enforces the Canada Consumer Product Safety Act (CCPSA) and its regulations by conducting investigations, inspections, seizures and prosecutions. The CPSP also responds to reports of consumer product-related health or safety concerns from industry and consumers.
Under section 14 of the CCPSA, industry must report to Health Canada after becoming aware of a health or safety incident involving a consumer product that they manufacture, import or sell. If applicable, they must also inform the person from whom they received the product. Subsections 14(2) and 14(3) of the CCPSA outline the timelines for reporting an incident.
These incident reports allow Health Canada to quickly identify and act on health or safety issues in the Canadian marketplace. Failure to report incidents to Health Canada within the required timeframe is an offence under the CCPSA. In the event of an incident, establishments that have a well-established process for reviewing the safety of products, controlling products under review and reporting to Health Canada within the required timelines could reduce the exposure of consumers to hazards.
In October 2018, Health Canada published an update to the online Industry Guide on Mandatory Reporting under the Canada Consumer Product Safety Act to help industry better understand its obligations under section 14 of the CCPSA. The guidance was revised to improve clarity and the use of plain language throughout the document. It provides better direction for industry on when to report, specifically, not waiting for a complete investigation or for absolute certainty before first reporting an incident. The updated guide also provides further instruction on requesting an extension to reporting timelines. The guidance document is an unofficial summary of the requirements under section 14 of the Act. In case of any discrepancy between the guidance document and the legislation, the legislation will prevail.
During the 2018-2019 fiscal year, Health Canada conducted a Cyclical Enforcement (CE) project on Mandatory Reporting. The purpose of this project was to verify compliance of industry with the section 14 requirements specific to incident reporting under the CCPSA.
The compliance of the selected establishments with the section 14 requirements under the CCPSA was determined through a process by which Health Canada inspectors visited establishments and reviewed their documents. Inspectors reviewed product complaints received by the company over a specific timeframe and determined if any of the events met the definition of an incident, and therefore, should have been reported to Health Canada.
The CPSP used internal data to select six establishments across Canada for this project and inspected them between October 2018 and February 2019. Establishments were asked to report any un-submitted incidents that were identified during the inspection to Health Canada within the given timelines. If applicable, they were also requested to provide an action plan of how they will ensure reportable incidents are received, assessed and reported to Health Canada in a timely manner in the future.
Overall, Health Canada determined that industry is sometimes failing to assess complaints and report incidents appropriately against the section 14 requirements set out in the legislation and is not reporting within the section 14 timelines. Additionally, some establishments do not prioritize training for all levels of employees involved in processing complaints received by consumers, determining if the complaint should be reported to Health Canada as an incident, and submitting the report to Health Canada, resulting in section 14 reporting requirements not being met.
The inspected establishments committed to fulfilling their responsibility to report consumer product incidents to Health Canada within the required timelines and implementing corrective measures as part of their action plans submitted during the project. Health Canada will monitor the establishments to ensure they meet their commitments.
The updated Industry Guide on Mandatory Reporting was published in October 2018; therefore many establishments were informed of the revisions to the Industry Guide at the time of their inspections for this CE project. It is expected that the recommendations and guidance provided in the Industry Guide will assist establishments in assessing incidents appropriately and reporting them within the prescribed timelines.
Health Canada will continue to work with industry and promote the updated Industry Guide on Mandatory Reporting so that incident reports relating to consumer products are properly assessed and reported in a timely manner.
Disclaimer: A systematic bias was applied during inspection targeting. Establishments were not randomly selected but were chosen because they were deemed by the inspector to meet the parameters of the project. The findings of this project may not reflect the overall compliance of establishments in Canada.
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