The proposed regulations would require food businesses to have preventive controls in place to identify and manage food safety risks before products are sold to consumers.” While this may sound like a quote about the U.S. Food Safety Modernization Act, it’s actually a direct quote from the government of Canada about its newly proposed Safe Food for Canadians Regulations (SFCR), published January 21. When finalized, the regulations will bring into force the Safe Food for Canadians Act initially published in 2012 – five years ago – again, ringing a bell of familiarity. And the similarities are not coincidental. As the government also explains: “The proposed regulations are in line with approaches being taken by these key trading partners to better manage food safety risks” and to ensure Canada’s trading partners “continue to have confidence in our food safety system because the proposed regulations are aligned with internationally-recognized standards.” SFCR Fundamentals Among the most essential changes that the proposed SFCR brings to the Canadian food system are: Harmonization. It aligns all foods under a single regulation – consolidating 14 sets of existing regulations into one. Canada’s food regulations currently focus primarily on specific commodities. SFCR brings more harmonization of regulatory programs across the food industry – with some differing specifications remaining for products such as meats and produce. Licensing. Once the regulations go into effect, all those who manufacture, process, treat, preserve, grade, package, or label food, or slaughter food animals, for export or inter-provincial trade, and those who import food will be required to be licensed.
Although similar to the U.S. Reportable Foods Registry, in order to attain the Canadian license, businesses must attest that they “meet the applicable requirements of the proposed SFCR, including having a preventive control plan (if required).” And meat plants must provide an approved work-shift agreement for activities relating to processing meat products and slaughtering food animals.
The licensing would enable CFIA to collect information about the activities of food businesses; better focus inspection and enforcement resources on operations with higher risk; and take enforcement action, such as license suspension and cancellation, when non-compliant activities are found. To help food businesses determine if they need a license, the government provides a “Would you need a license?” tool. Written Preventive Controls. As previously mentioned, the proposed SFCR sets key food safety controls for prevention and, like FSMA, would require the development, implementation and maintenance of a written preventive control plan. However, along with documentation of food safety practices, the SFCR plan is also to include documentation of how marketplace fairness requirements are met for labelling, packaging, standards of identity, grades, humane treatment and net quantity. U.S. producers also need to be aware that, while the preventive controls wording sounds very similar, there are differences in the specifics, with the SFCR plan more aligned with HACCP than with FSMA specifics. The proposed SCFRs are more outcome based with somewhat less prescriptive detail on how companies manage their preventive control programs. For example, the SCFRs do not have a mandatory requirement for a Preventive Control Qualified Individual, but it is understood that a CFIA inspector will be looking at knowledge and competence of a company’s food safety staff as part of an inspection or audit under SCFR. Previously only meat and fish processors had had mandatory HACCP controls. This also makes it likely that the implementation of the rules may vary a bit for these processors, both because such entrenched regulatory programs can’t be changed overnight, and because of agreements with the USFDA and USDA which must continue to be assured, so as to not disrupt trade. Fruits and Vegetables. Like FSMA’s Produce Safety Rule, the proposed SFCR brings new regulations for produce which had minimal food safety rules in the past. What Importers Need to Know The most important aspect of the proposed rule that importers need to know is that you will need to be licensed through the CFIA system if you wish to have your food imported into Canada. And you must meet the same requirements. Although the proposed rule does provide some modifications for small businesses, such as longer timeframes for compliance, and businesses with gross annual sales of food of ≤$30,000 would not be required to have a written preventive control plan – these modifications don’t apply to imported and exported foods. Thus, even if a small U.S. processor is exempt from FSMA, it will still have to comply with FSMA if it wants to ship its product into Canada. Thus, all imported food must have a preventive control plan demonstrating that it has been manufactured, prepared, stored, packaged, and labelled under similar food safety controls as food prepared in Canada, with at least the same level of protection provided by the applicable preventive controls. The could be attested by the foreign supplier or a third party such as an accredited body. Additionally, the importer of prepared foods must have procedures and processes for handling and investigating complaints and food recalls. High-Risk Foods Along with the changes the new regulations bring to food processors, there will be significant changes for CFIA and its allocation of resources. Having previously had commodity-specific rules, its inspectors were often tied to commodities. While there will still be a need to have expertise in commodities, there will need to be a significant shifting of resources so that CFIA inspection resources are allocated based on inherent risk of product and processing types. This is likely to mean to some processors who never saw an inspector can expect to receive a visit, and some who saw inspectors a lot, may have fewer visits. It also means that importers are more likely to have more inspections. Overall, CFIA will be needing more resources to enforce the new rules than it did in the past. So, at least initially, it will likely be focusing its resources on processors and importers of higher-risk foods and produce. The rulemaking process is, again, similar to that of the U.S., in that CFIA has set a 90-day comment period, after which it will review all input and develop the final rule. At this point, it is hard to predict when the new SCFR regulations will be finalized. To date, they have not generated much controversy with industry and other stakeholders. If this continues, the regulations could be finalized shortly after the comment period ends. However, if issues of significant concern arise among stakeholders, there is the possibility of further consultation and review by parliamentary committees and the government. However, all signs currently point to successful implementation. CFIA will be creating guidance documents and other communications around the new rules, with one good Q&A handbook already on its site: Understanding the Proposed Safe Food for Canadians Regulations: A Handbook for Food Businesses. Additionally, TAG now has dedicated resources and expertise in Canada’s food regulatory system. For more information, contact [email protected]. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com