On May 27, 2014, the Canadian Food Inspection Agency ("CFIA") released an Overview of the proposed regulations under the Safe Food for Canadians Act (the "SFCA"). This is the latest deliverable in Health Canada's modernization makeover, and sets the stage for ongoing consultation on what will become Canada's new food safety regime.
Our February bulletin on this issue previewed some of the proposed changes, and included information on the motivation behind Health Canada's modernization efforts.
This latest document follows the June 2013 discussion paper entitled "Proposed Regulatory Framework for Federal Food Inspection" (the "Proposed Framework"), which marked the first step in the CFIA's regulatory transformation process under the SFCA. Consultation on the Proposed Framework was broad: the CFIA consulted with over 2,000 stakeholders and received over 75 written submissions from trade associations, individuals and other governments.
The information received during that consultation has been considered by Health Canada and incorporated into the proposed regulations.
From Licensing Rules to Quality Control: Key Sections of Proposed Regulations
As expected, the proposed regulations establish minimum food safety requirements for all food imported or prepared for interprovincial trade or export. Wherever possible, they reflect internationally-recognized standards and provide outcome-based requirements. Consistent with previous declarations from the CFIA on the SFCA, the new regulatory framework focuses on prevention, makes industry responsible and accountable for preparing safe food, and promotes consistency in the CFIA's approach to inspection.
Here are some of the key elements of the proposed regulatory framework, as set out in the Overview:
The proposed regulations require licensing of everyone (a) importing, (b) preparing food for export or inter-provincial trade, or (c) exporting food in respect of which an export certificate will be sought. In addition to issuance of a license number, establishment numbers will be issued to further facilitate risk-based oversight of industry.
Licenses would be valid for a period of 2 years, at a cost of approximately $250. Parties can seek a single license to apply to all of their activities or multiple licenses (i.e. one for each establishment, activity or food commodity). An inspection may be required before issuance, renewal or amendment of a license, depending on the nature of the product and compliance history of the licensee. It is proposed that the Minister be able to suspend a license upon a finding of non-compliance with legislative or regulatory requirements.
- For importers: The proposal would require all license holders (i.e. importers) to have a fixed place of business in Canada or in a foreign country with a food safety system similar to the one in Canada. This addresses concerns raised during previous consultation that requiring importers to have a Canadian address could result in significant costs. CFIA will release a draft Framework for Foreign Food Safety Systems Recognition to further elaborate on this element of the proposed regulations.
- For brokers and distributors: Warehouses and distribution centers would not be required to have a license unless they also conduct an activity that subjects them to the licensing requirements. However, the proposed regulations would require that food sent or conveyed inter-provincially or exported from Canada be prepared by a license holder. Thus, these parties will be required to ensure that they source food from licensed entities.
- For exporters: The proposed regulations would require licensing of all persons preparing food for export. Anyone who exports food would be required to ensure that it was prepared by a license holder, and that it meets the requirements of the importing country. The CFIA will continue to provide export certificates; any company that requires one will be required to have a license and preventive control plan in place.
As expected, the proposed regulations adopt the Codex Alimentarius standard for traceability: one step forward, one step back. Companies that import, export or trade inter-provincially will be required to track food forward to the immediate customer and backwards to the immediate supplier.
The proposed regulations would require traceability information to be provided to the CFIA upon request electronically, in plain text and in a format that can be imported and manipulated by standard commercial software, in English or French. Further, this information will be required to be accessible in Canada and maintained for a minimum of 3 years for all products.
Food Safety - Good Manufacturing and Agricultural Practices
The proposed regulations establish minimum requirements for everyone who imports, prepares, grows or harvests food for inter-provincial trade or export. These baseline requirements require companies to address the seven key elements to good manufacturing and agricultural practices: products and processes; sanitation and pest control; hygiene and competencies; equipment and conveyances; physical structure and maintenance; receiving, transportation and storage; and investigation and notification, complaints and recall procedures.
Preventive Control Plans
The proposed regulations would require preventive control plans ("PCPs") for (a) every license holder, (b) every person who grows or harvests fresh fruit or vegetables for inter-provincial trade for direct sale to the consumer without further manufacture, preparation, storage, packaging or labelling, and (c) every person who prepares food for export, or grows and harvests fresh fruits and vegetables for export
The requirements around PCPs are expected to be consistent with HACCP, and CFIA will provide "model systems" and further guidance on developing and maintaining suitable plans. The preparation of a PCP will require parties to identify and document potential hazards associated with their foods or process, and to demonstrate how those hazards will be controlled. PCPs will be one of the key tools used by CFIA inspectors to verify compliance with the SFCA and its Regulations.
The CFIA is proposing a staged implementation approach to the new regulations, recognizing that industry is at vastly different levels of readiness:
- Current federally-registered sectors (meat, fish, dairy, eggs, processed fruits and vegetables, honey and maple products): license and PCP requirements in force in 2015;
- Fresh fruit and vegetable sector: license requirements in force in 2015 and PCP requirements in force in 2016; and
- Non-federally-registered sectors: license requirements in force in 2016 and PCP requirements in force in 2017.
CFIA Currently Seeking Stakeholder Comments
With the release of the Overview and invitation to consult on its content, the CFIA is providing stakeholders with an opportunity to consider and provide feedback on the proposed regulations before the formal regulatory consultation begins. To that end, the CFIA will accept comments on the proposed regulations as outlined in the Overview until July 21, 2014.
The CFIA will consider any comments received by July 21st prior to publication of the proposed SFCA Regulations in Part 1 of the Canada Gazette, expected in late Fall 2014. This publication will be followed by a formal 75-day consultation period. The proposed regulations are expected to be published in Part 2 of the Canada Gazette in mid-2015.
The regulations will also be supplemented with a new suite of Health Canada guidance documents and model systems aimed at assisting industry in complying with the new regulatory requirements.
Once the SFCA and its Regulations are fully in-force, only two federal legislative regimes will govern the regulation of food in Canada: the Food and Drugs Act and the SFCA.
We will continue to keep you apprised of developments related to this and Health Canada's other modernization efforts by way of further Bulletins. If you are interested in receiving future Bulletins, please subscribe here.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.