Thursday, January 31, 2019

Safe Food for Canadians Regulations II


Safe Foods for Canadians
Canada is known to have one of the strongest food safety systems in the world, which is further strengthen through new safe foods for Canadians act by synchronizing several sets of different regulations into a single set of modern regulations to govern food safety. As Government of Canada finalized the SFCR in June 2018, now there are one single regulation which has eventually phase-out previous 14 sets of regulations. The current system introduced has well informed, carefully planned with the support of extensive consultations from diverse industry sectors including food businesses, food experts, everyday Canadians, and trading partners abroad in addition to the public consultations on the SFCR.  These activities underline the Government of Canada’s commitment to new regulatory system to be more agile, transparent and responsive, where open approach to regulatory development serves as the foundation for public trust both in Canada and beyond borders. The new consolidated act and regulations, which came into force on January 15, 2019, expected to protect Canadian citizens by making the food system even safer by focusing on prevention and allowing for faster removal of unsafe food from the marketplace. They will also position Canadian food businesses to act on new opportunities, be more competitive, and grow new markets.

Nonetheless, Canadian Food Inspection Agency acts as the leading agency for implementation of World Trade Organization’s Agreement on the Application of Sanitary and Phytosanitary Measures, which plays a significant role in the three official international standard-setting bodies (ISSBs) to promote science-based international standards. The Codex Alimentarius (Codex) standards provide the foundation for robust domestic regulatory systems and contribute to a predictable trade environment, reducing business risks and facilitating market access. On the other hand, international approaches to food safety are changing dynamically, where Codex maintains food standards, guidelines and codes of practices that promote the use of systems-based, preventive approaches for the food safety. Hence, these strategies integrates Hazard Analysis and Critical Control Point (HACCP) principles, Good Manufacturing Practices (GMPs), and Good Agricultural Practices (GAPs) to address safety and quality along the entire food production and distribution continuum by identifying and controlling hazards in order to prevent food safety problems. These systems-based approaches recognize that those who prepare or import food have the primary responsibility for the safety of their products and must implement preventive programs to identify and control hazards.

Modern trends in the developed world is vertically integrating latest developments in the field of food safety where several countries have made significant progress adopting the modern approaches described by Codex as they modernize their own food safety systems. i.e., the United States has introduced the Food Safety Modernization Act (FSMA) and associated regulations that grant new and expanded authorities to the U.S. Food and Drug Administration to enhance the safety of the U.S. food supply. Hence, Canada and the United States are working together to harmonize these new regulatory approaches between the two countries where possible, including approaches on food safety. Under the Regulatory Cooperation Council (RCC), the CFIA has been working with its counterparts in the U.S. Department of Agriculture and the U.S. Food and Drug Administration on a number of food safety initiatives, some of which will be furthered by the proposed Regulations.

Objectives
One of the key objectives of the proposed Regulations are to apply internationally recognized standards for ensuring food safety for the food which are imported into or prepared in Canada for interprovincial trade or for export. This would better prevent food safety incidents and assist in rapidly removing unsafe food from the market when incidents occur.

On the other hand, it intended to support market access for Canadian exporters while catchup pace with food safety modernization efforts in other countries, such as the United States, who are moving to systems-based approaches, which will further strengthen the Canada’s reputation for having a world-class food safety system.

Most importantly, consolidate 13 food commodity-based regulations plus the food-related provisions of the CPLR to a single set of more outcome-based requirements (i.e. requiring an expected result instead of listing steps to achieve the expected result), where appropriate. Hence, new act would improve consistency, enable innovation and flexibility, and level the playing field across foods and between importers and domestic preparers of food for export or interprovincial trade.

The Regulatory Framework
The proposed Regulations contain 17 parts and would include requirements respecting the following:
Trade;
Licenses;
Preventive Control Measures;
Traceability;
Commodity-specific Requirements;
Recognition of Foreign Systems;
Ministerial Exemptions;
Inspection Legends;
Packaging;
Labelling;
Grades and Grade Names;
Seizure and Detention; and
Organic Products.

Some of the requirements would be phased in to reflect different levels of industry readiness and the concerns of small businesses that are involved in importing food, or preparing food for export or for interprovincial trade. The SFCA also provides for authority to incorporate by reference in the Regulations documents that are internally or externally generated as of a particular date or that may change over time. The flexibility to change an incorporated document would allow the CFIA to make its regulatory framework more responsive to concerns of industry and consumers by responding more promptly, where necessary, to modern science and innovations, which might otherwise require regulatory change. Before making changes to internally generated, incorporated documents that may change from time to time, the CFIA would consult with stakeholders in a similar way as consultations for regulatory changes and in accordance with the CFIA’s Incorporation by Reference (IBR) Policy.

Key Food Safety Elements
The proposed Regulations would establish three key food safety elements:
Licenses:
As to the proposed Regulations, licenses would be required for food importers, for persons (e.g. food businesses) preparing food for export or for interprovincial trade, with some exceptions, and for persons slaughtering food animals from which meat products for export or interprovincial trade may be derived. License applications would require certain information from the applicant regarding their identity (e.g. business name) and business activities, which would inform risk-based oversight. The proposed license would be valid for a period of two years for a fee of approximately $250, and could be suspended or cancelled in cases of non-compliance. Regulated parties would be able to apply for one or multiple licenses.

Traceability:
The proposed Regulations are intended to apply international standards for traceability established by Codex to persons importing, exporting or interprovincially trading food, as well as to other persons holding a license issued under the SFCA. It also applicable to growers and harvesters of fresh fruits or vegetables that are to be exported or traded interprovincially. Electronic or paper records would be required to be prepared and kept in order to track food forward to the immediate customer (e.g. a retailer or another food business) and backwards to the immediate supplier (i.e. one step forward, one step back along the supply chain), but retailers would not be required to trace forward their sales to consumers.

As a specific circumstance, the proposed regulations would require that traceability information be provided, upon the Minister’s request, within 24 hours, or some shorter period, if the information is considered necessary to identify or respond to a risk of injury to human health, or some longer period if the information is not considered necessary for a recall that is or may be ordered. The information would need to be provided in French or in English and, where electronic, in a format that could be imported and manipulated by standard commercial software. The information would need to be accessible in Canada.

Preventive Controls and Preventive Control Plan (PCP):
The proposed regulations would require food subject to the regulations and activities (i.e. importing, preparing meat products for export or interprovincial trade) to meet food safety requirements and that those activities be conducted in a manner that is consistent with internationally recognized agricultural and manufacturing practices (i.e. GAPs, GMPs and HACCP). The proposed Regulations would address the following key preventive control elements:
Sanitation, pest control, and non-food agents;
Conveyances and equipment;
Conditions respecting establishments;
Unloading, loading and storing;
Competency (i.e. for staff);
Hygiene;
Communicable diseases and lesions; and
Investigation and notification, complaints and recall.

In addition to the given three key food safety elements, certain commodity-specific requirements for food safety would remain in place where appropriate, i.e., the current regulations require imported meat products to be sourced from a country with an inspection system that is approved by the Minister under the MIA. This requirement would be maintained in the proposed Regulations.

With some exceptions, regulated parties are required to produce and maintain a written preventive control plan demonstrating how the preventive controls and other requirements (e.g. for packaging and labeling) are met. On the other hand, regulated parties have the flexibility to apply the preventive controls and other measures on an outcome-based approach where appropriate, to demonstrate that their operations and food products comply with the proposed regulations.

The steps related to the preparation of a PCP should be based on HACCP principles and would include, where applicable:
A description of the biological, chemical, and physical hazards which could contaminate the food, the measures used to prevent or eliminate those hazards, and evidence that the measures are effective;
A description of critical control points (steps at which a control can be applied and that is essential to prevent or eliminate the hazard), their related control measures, and evidence that they are effective;
A description of the critical limits (i.e. the limit at which a hazard is acceptable without compromising food safety) for each critical control point;
The procedures for monitoring the critical control points in relation to their critical limits;
A description of the corrective action procedures for each critical control point;
A description of the procedures used to verify the implementation that the PCP meets the requirements of the SFCA and the proposed regulations;
Documents which can demonstrate that the information has been recorded on time and where PCP has been implemented with respect to the foregoing.

As a standard requirement with subject to certain exceptions, a written PCP would be required for:
Every license holder who imports food or prepares food to be sent or conveyed from one province to another;
Every person who grows or harvests fresh fruits or vegetables to be exported or to be sent or conveyed from one province to another;
Every license holders preparing fish products or meat products to be exported;
Every person, including a license holder, exporting food who requires or requests an export certificate from the CFIA.




References


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