Are we ready for a recall? In the unfortunate circumstance that a recall is required, a well-executed recall plan can minimize regulatory and business risks, and play a vital role in maintaining goodwill with key partners.
The Canadian Food Inspection Agency (CFIA) currently expects businesses to report food recalls and has published guidance for industry on recall plans. The proposed Safe Food for Canadians Regulations (SFCR), published for consultation in January, impose new legal obligations with respect to preparing for, reporting and managing recalls. For many in the industry, these changes necessitate a fresh look at whether your business is adequately prepared.
It is important to understand what kind of action is considered a recall. While the term "recall" is not defined in the proposed SFCR, CFIA provides some relevant definitions in its guidance documents:
"Product Withdrawal" means a firm's removal from further sale or use of a marketed product that does not violate legislation administered or enforced by the CFIA. It is not considered to be a recall.
"Recall" means for a firm to remove from further sale or use, or to correct, a marketed product that poses a risk and/or contravenes a legislation administered or enforced by the CFIA.
Based on these definitions, any removal from the marketplace relating to a contravention of legislation is a recall - even non-safety related label violations. These classifications potentially increase the number of Class III recalls, and can create a disincentive to industry to take proactive non-safety corrective actions.
With the aim of continuous modernization, CFIA has recently proposed a new type of action called a market withdrawal. This category has been added to enable the classification of proactive actions from companies that go beyond the CFIA's criteria for a recall. A market withdrawal, like a product withdrawal, is not considered to be a recall and will not be posted on the CFIA's website. The CFIA's proposed definition of a "market withdrawal" is a company initiated removal or correction of product that is in violation of legislation administered or enforced by the CFIA, but does not represent a level of health risk and/or conditions that meet CFIA's criteria for requesting a recall. As this new concept has yet to be finalized in guidance, consultation with CFIA is recommended in order to confirm that an action meets the criteria to be considered market withdrawal and not a recall.
With respect to preparing for and managing recalls, the proposed SFCR requires businesses to document traceability information, make such information accessible in Canada and available upon the Minister's request within 24 hours, or less if it is considered necessary to identify or respond to a risk of injury to human health. Licence holders (e.g. manufacturers, importers) are required to prepare and maintain a written recall procedure (including the name of the contact(s) who are responsible for the procedure and for conducting recalls) and to conduct a recall simulation at least once a year. In the event of a recall, the Minister must be immediately notified and recall procedures implemented. Recall details, including information to substantiate its effectiveness, must be kept for two years.
Keep in mind that recalls can occur at any time, so your business may have to manage a recall when the main contact is inaccessible due to health, personal issues, or travel. It is essential to ensure that the business has trained staff who can step in.
As consumers now have access to instantaneous information through technology and social media (CFIA's Twitter page has a #CFIArecall), effectively managing marketplace actions including recalls is not only essential to protect consumer health and safety, but to ensure that partners and consumers are properly informed about the steps a business is taking to address the issue. When the SFCR are in force, ensuring that processes are in place to effectively manage a recall in cooperation with CFIA will become an even more crucial risk reduction measure from a legal perspective.
Laura Gomez and Katrina Coughlin are associates in the Ottawa offices of Gowling WLG, specializing in food and drug regulatory law. Contact them at email@example.com and Katrina.Coughlin@gowlingwlg.com.