A New Regulatory Framework For Food Safety In Canada
The Federal Government of Canada has signaled with its passage of the Safe Food for Canadians Act (the "Act") its intention to develop a more robust and comprehensive approach to food safety regulation in Canada. The Act, which received royal assent in November 2012 and is expected to come into force sometime in early 2015, is intended to consolidate the regulatory authorities granted under several federal statutes, namely the Canada Agricultural Products Act, the Fish Inspection Act, the Meat Inspection Act and the food provisions of the Consumer Packaging and Labelling Act. In the meantime, the Canadian Food Inspection Agency ("CFIA") released a consultation document entitled "A New Regulatory Framework for Federal Food Inspection: Overview of Proposed Regulations", which provides, as the name suggests, an overview of the new proposed regulatory framework under the Act and the preliminary text of key elements of the proposed regulations (the "Proposed Regulations"). While the initial consultation period closed on August 29, 2014, the Proposed Regulations are not expected to be published until mid-2015 after the completion of the formal consultation period following pre-publication of the full regulations.The Proposed Regulations will consolidate existing CFIA commodity regulations into a "single set of food regulations and establish minimum food safety requirements for all food imported or prepared for inter-provincial trade or export" while maintaining existing commodity-specific requirements where necessary. Once in force, the Act and the regulations, together with the Food and Drug Act ("FDA") and the Food and Drug Regulations ("FDR"), which apply to all food sold in Canada, will provide appropriate legislative tools to streamline food safety regulation, and which will focus on prevention and enhancing capacities to respond to food safety incidents.
The Proposed Regulations focus on five key elements: licensing, trade, traceability, food safety requirements and the preventative control plan. The CFIA considers these elements to be transformational changes to the exiting food inspection regime that will impact all food imported, exported or traded inter-provincially.
Licensing and Trade
The Proposed Regulations would require any person or entity that imports, prepares food for export or for inter-provincial trade or exports food for which an export certificate is sought to obtain a license and to comply with the Act and the regulations. The license would be valid for two years, renewable thereafter for successive two-year periods, and would require the payment of a fee. Regulated parties would be able to apply for multiple licenses, that is, for each establishment, activity or food commodity, or a single license for all establishments, activities and food commodities. Basic information regarding the identity of the applicant, its locations and activities would be required as part of the application process.
Based on the information submitted in the license application, and depending on product risk and compliance history, an inspection may be required prior to the issuance, renewal or amendment of a license. An inspection is more likely where the applicant or license holder's activities involve foods that have traditionally been recognized as posing higher food safety risks, such as meat, fish, dairy and eggs. The Proposed Regulations would permit the CFIA to suspend a license for non-compliance. Immediate suspension could result where there is a risk to human health.
Exporters, in addition to the licensing requirement, would have to otherwise comply with the Act and the regulations, including labelling, packaging, standards and documentation requirements. Food that is sent or conveyed inter-provincially or outside of Canada would have to be prepared by a license holder. This requirement is intended to ensure that those involved in such activities, for example, brokers, distribution centres and internet sellers, source their products from license holders. Importers would be required either to maintain a fixed place of business in Canada or in a foreign state that has a food safety system that provides protections similar to those in Canada.
Certain exemptions would be carved out similar to those that currently exist under other regulatory regimes. Thus, foods prepared for personal use or foods not prepared for human consumption such as pet food would not be subject to the licensing requirement. It is further proposed that alcoholic beverages and food additives, both which are otherwise regulated, be exempted from the Act and its regulations.
Traceability
Under the Proposed Regulations, what has been to date a patchwork of voluntary tracing systems would be replaced by the application to all license holders of the international standard of traceability established by Codex Alimentarius. The new standard would require the maintenance of records tracking food forward to the immediate customer and backwards to the immediate supplier. Such records would have to be kept for all food products, including perishables, for three years. The rationale for the standard is to provide more accurate information that would, in the event of a food safety incident, permit the rapid identification of the origin and movement of food products through the supply chain.
The information retained under this protocol must be made accessible in Canada and must, on request, be provided electronically in plaint text or in a format that can be imported and manipulated by standard commercial software.
Food Safety Requirements
The CFIA proposes that the regulations under the Act establish minimum food safety standards for any person or entity that imports, prepares, grows or harvests food for inter-provincial trade or export, regardless of commodity or size of export, including requirements that address seven key elements to good manufacturing and agricultural practices, namely:
- Products and processes
- Sanitation, pest control, sanitizers and chemical agents
- Hygiene and competencies
- Equipment and conveyances to ne used in an establishment
- Physical structure and maintenance of the establishment
- Receiving, transportation and storage
- Investigation and notification, complaints and recall procedures
Preventative Control Plan
The Proposed Regulations would require,
- every license holder that imports a food or prepares a food to be sent or conveyed from one province to another,
- every person who grows or harvests fresh fruit or vegetables to be sent or conveyed from one province to another for direct sale to the consumer without being further manufactured, prepared, stored, packaged or labelled, and
- every person who prepares food for export, exports or grows and harvests fresh fruit and vegetables for export, that require a certificate from the CFIA,
The PCP would have to identify and document potential hazards associated with regulated parties' food products or processes. Regulated parties would also have to demonstrate how those risks and hazards can be controlled or ameliorated and would have to identify how the requirements specified in the Proposed Regulations, including the seven key elements discussed under the heading "Food Safety Requirements" above, would be addressed. Control measures would need to be validated by evidence that establishes their efficacy in controlling identified hazards. The PCP would also have to identify the measures taken to comply with other regulatory requirements, including those under the FDA and FDR.
The PCP is intended to be a key tool to verify compliance with the Act and its associated regulations. In order to facilitate the implementation of PCPs, the CFIA will provide "model Systems" derived from existing materials that have proved to be effective when properly applied. The CFIA will also provide "validations" that are consistent with the Codex Alimentarius.
The Proposed Regulations exempt from the PCP requirement micro-businesses that have a total food revenue over the previous 12-month period of less than $30,000 at the time the application for a license is made. However, the exemption will not be available for those micro-businesses that are currently subject to similar food safety requirements involving food products that are internationally recognized as having heightened food safety risks, such as meat, fish, dairy, egg, processed egg and processed products. Notwithstanding this limited exemption, small businesses will still have to comply with the licensing and food safety requirements discussed above.
Coming into Force
Although it is expected that the Proposed Regulations will be published in mid-2015, its provisions will come into force over time in recognition that various industry sectors are at widely different levels of readiness. For "federally registered" sectors and those licensed under current regulatory regimes, both of with are already under CFIA oversight, compliance is expected to be relatively straightforward. These "registered" entities would be required to meet the licensing requirement and to develop and implement PCPs in 2015. The fresh fruit and vegetable sector, which is currently regulated under the Fresh Fruit and Vegetable Regulations, would become subject to the licensing requirement in 2015 and the PCP requirement in 2016. Entities not currently registered under federal regulations, which includes some large industry players but also small and medium sized businesses that have little familiarity with internationally recognized food safety practices or the CFIA, will have to comply with the licensing requirement in 2016. The PCP requirement will apply to those entities in 2017.
Conclusion
The Proposed Regulations will have significance to those franchisors that import food products as part of their business operations. Each will have to obtain the required license, comply with the food safety and traceability requirements, develop, implement and maintain a Preventative Control Plan and otherwise comply with the Act and regulations when they come into force. Effective and compliant record keeping protocols will also have to be established. For those franchisors currently under CFIA oversight, the transition into the new regulatory framework should be relatively simple. Franchisors that fall into the "non-registered" category will be given more time to comply with the licensing and PCP requirements under the Proposed Regulations. The CFIA is currently in the process of developing an updated suite of guidance documents and model systems to help all industry players orient themselves to the new reality.
This is a brief outline and one of a series of articles designed to assist franchisors in understanding some of the issues faced by them. Careful planning, coupled with expert legal and financial advice, is essential to ensure the success of any franchise system. Mr. David Kornhauser, one of the lawyers behind the website www.franchisingforum.ca, provides advice franchisors about franchise law to in Toronto, Ontario or elsewhere across Canada. You can reach Mr. Kornhauser either at or david@franchisingforum.ca.
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