In anticipation of the Canada Consumer Product Safety Act (the “CCPSA”) coming into force on June 20, 2011, Health Canada has just released two new drafts of its consultation documents for stakeholder comment.
The CCPSA introduces a comprehensive regulatory regime for consumer product safety in Canada. Amongst other obligations, it imposes record-keeping and incident-reporting requirements on manufacturers, importers, and sellers of consumer products. The two draft guidance documents that have been released deal specifically with these issues. They are open for comment until April 8, 2011.
guidance on preparing and maintaining documents
Health Canada’s Draft Guidance on Preparing and Maintaining Documents (found here) seeks to clarify the record-keeping requirements imposed by the CCPSA. Generally, any person who manufactures, imports, advertises, sells and tests consumer products for commercial purposes will soon be under a duty to prepare and maintain specific information for a period of six years from the end of the year to which it relates.
what records must be kept?
The CCPSA requires all parties mentioned above, other than retailers, to keep documents identifying from whom they obtained the product and to whom they sold it. It requires retailers to keep the name and address of their suppliers, along with the location where and the period during which the consumer product was sold. The guidance document confirms that retailers are not required to keep records relating to every consumer transaction or the personal information of consumers.
The guidance document also indicates that additional record-keeping requirements for certain products will be carried over from the Hazardous Products Act and incorporated into the Regulations under the CCPSA. These are identified at the end of the guidance document.
how long must records be kept
The guidance document confirms that the 6-year time requirement refers to calendar years, not fiscal years. Thus, a record relating to June, 2011 must be kept until December 31, 2017.
providing records to Health Canada inspectors
The CCPSA permits Health Canada inspectors to demand access to certain documents that must be provided upon written request. The time period for providing documents will depend on the circumstances and will be outlined in the request. Presumably, if permission to keep documents outside of Canada has been granted, companies will be permitted a longer time to produce them.
exemptions to keeping records
Health Canada is exploring the possibility of providing an exemption to the record-keeping requirements for donees of consumer products donated by someone other than a person who manufactures, imports or sells the product. The reasoning is that the preparation and maintenance of records in this situation would add little to the traceability of the product.
Finally, the guidance document advises that Health Canada is prepared to receive documents electronically or in hardcopy, as long as: (i) the required information is clearly identified; (ii) the document is in either English or French; and (iii) the document is legible. It is recommended that companies put policies and procedures into place that will ensure the preparation and maintenance of these records.
guidance on mandatory incident reporting
The second consultation document (found here) addresses the mandatory reporting requirements imposed by the CCPSA on manufacturers, importers and sellers. In general, manufacturers, importers and sellers of consumer products must report when they “become aware” of an “incident” (as defined in the Act). This requirement has raised a host of interpretation issues that the guidance document attempts to address.
who has to report?
As noted above, reporting obligations are imposed upon manufacturers, importers and sellers of consumer products. The guidance document suggests that certification bodies, testing laboratories, raw material suppliers and advertising agencies would not normally have reporting obligations. The document also confirms that if a person fulfills more than one role (i.e. manufacturer and seller), they need only report in respect of the role that is highest in the supply chain.
what is a reportable “incident”
An incident, as defined in the CCPSA, is any of the following – an occurrence in Canada or elsewhere, a defect or characteristic, or incorrect or insufficient information on a label or instructions – that resulted, or may reasonably be expected to result, in death or serious adverse effects on health. An incident also includes a recall initiated anywhere for health or safety reasons. (Note – see the Act for exact language.) Health Canada provides examples of each of these in the guidance document.
The guidance document also confirms that for an event to rise to the level of an incident, and thus be reportable, it must be linked to the normal or foreseeable use of the product. However, if misuse of a product is reasonably foreseeable, it may also give rise to a reportable incident.
The guidance document suggests a two-step inquiry for determining whether an event is reportable:
- Is the event “related” to a consumer product that one manufactures, imports or sells in Canada for commercial purpose?
- Does the event meet one of the criteria comprising an incident?
In determining whether the event is “related” to the consumer product, Health Canada recommends a broad interpretation. It suggests, for example, that if a recall has been initiated in another country on a product that contains the same component part as the product sold in Canada, this may constitute an event “related” to the latter product notwithstanding that the two products may not be the same.
The guidance document also confirms that information relating to an incident can be received (and give rise to the requisite “awareness”) in a variety of ways including direct notification by consumers, government, standards bodies, suppliers, customers or non-governmental organizations. Information can also be received from experts, test reports, scientific studies, or any other direct notification with enough detail about the product and hazard to evaluate the event.
what is the timeline for reporting?
Manufacturers, importers and sellers of consumer products must report information within their knowledge to both Health Canada and the person from whom they received the product within two days of becoming aware of an incident. Manufactures or importers must also provide a more detailed report within ten days of becoming aware of an incident. The guidance document confirms that these references are to calendar days. However, if a reporting date falls on a holiday or Sunday, the report is due by midnight in the local time zone on the next non-holiday. While the two-day requirement is non-negotiable, Health Canada has discretion to agree to a different timetable for the ten-day requirement and has signalled it will do so where the manufacturer or importer needs additional time to investigate.
what must be reported?
Within two days, manufacturers, importers and sellers who become aware of an incident must report all information within their control. Within ten days, the manufacturer or importer must submit a further report about the incident, the product involved, any other products that could be involved in similar incidents, and any proposed countermeasures.
Health Canada will be developing an online Industry Form for Mandatory Reporting similar to the Consumer Product Incident Report found here. The on-line form will largely dictate what information must be provided at both stages of reporting.
confidential business information (CBI) and personal information
The Act gives the government authority to, without consent or notice, disclose CBI to other governments in certain conditions and to “anyone” in others. In addressing these powers, the guidance document states that if a company believes that incident information meets the definition of CBI under the CCPSA or the Access to Information Act, they should tell Health Canada at the time of disclosure. It also states that Health Canada will work with companies to mitigate safety concerns without releasing CBI where possible.
Finally, the guidance document clarifies that manufacturers, importers or sellers need not collect personal information of consumers related to an incident and that such information should not be provided at the time of reporting.
The CCPSA will be in force in a few short months. Companies are encouraged to ensure they have the necessary policies and procedures in place to ensure compliance with the new incident-reporting and record-keeping requirements. Stakeholders may also wish to consider reviewing the consultation documents discussed above and submit comments to Health Canada. The consultation is open from March 9, 2011 to April 8, 2011 and comments can be submitted via e-mail, mail or fax.