Preventive Controls for Human Food

Preventive Controls in Food Safety

The preventive controls approach has been universally accepted as a proactive and systematic approach to food safety and adopted throughout the world and continue to do so. Because it helps to attempt preventing issues before they arise while focusing on the most important areas to prevent food safety issues rather than reacting to problems as they arise. Preventive control programs are not new to the world even though the nomenclature is as they are already in use in combination in different models which has been structured to work in conjunction more effectively. The most common examples are; Good Manufacturing Practices (GMPs), good agricultural practices, good transportation practices including HACCP, PRPs, OPRPs, etc. as the basis for food safety management. Successful application of preventive controls approaches usually cover every angle of intended and not intended risks within or outside which is not only helps to ensure regulatory compliance, but also minimizes the risk of producing products that can harm consumers.

As of the history of preventive controls development in food industry, that dates back to the Apollo missions, where risk‐based approaches to managing food safety were pioneered during development of food for the U.S. space program in the 1960s. Initially, end‐product testing was the main focus of the quality control programs, where there were tremendous failures, as end‐product testing necessary to provide assurance that the food was safe would be so extensive that little food would be available for space flights, while there was no 100% credibility that leftover items are completely fit for use. Then focus was shifted from final product testing to preventing hazards (by the Pillsbury Company and Army laboratories as collaboration) through product formulation and process control in a risk‐based approach which was named as Hazard Analysis and Critical Control Point (HACCP). The HACCP implementation was gradually expanded voluntarily in the food industry.

The general understanding is that, food safety is best assured if each producer and processor understands the significant hazards in their product and operation, and if they use scientifically sound preventive controls to significantly minimize or eliminate the hazards. As a front liner, FDA used HACCP principles in the development of low‐ acid canned food regulations in the 1970s. The development further expanded when the U.S. National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and the Codex Alimentarius Commission (Codex) published HACCP principles in the 1990s. The expansion further took turns in the world food production with various applications into several subsectors, where FDA has HACCP regulations for seafood and juice products; USDA has HACCP regulations for meat and poultry products; and HACCP is endorsed by many countries, including Australia, Canada, New Zealand and European Union.

What is a Preventive Control Program?

The preventive control programs are in a rise in the modern food industry, as US FDA and Canadian Food Inspection Agency has already introduced preventive control programs to their food safety management system requirement as food safety modernization act (FSMA) and safe food for Canadians act (SFCA). However, these programs are not very different from their predecessors as already explains, but has been modernized, improved and additional requirements are brought to justice with more rigorous and systematic approaches. In the previous models, the HACCP principles are the heart of the program while rest is come around it, which is still same but more extended support programs and more risks has been considered. Thus, understanding of these principles are useful to understand how the Preventive Controls for Human Food regulations complements the risk‐based HACCP approach.

In a HACCP system, hazard analysis identifies process‐related hazards which, in the absence of control, present a food safety risk. Therefore, when such hazards are identified, Critical Control Points (CCPs) should be defined, while identifying that are essential to control the process to prevent the hazard from causing illness or injury to the human health. When these CCP process controls are identified, the critical limits should be defined for the operating conditions in the process that must be met to effectively manage the hazard. Nonetheless, monitoring of the process is carried out to provide data to demonstrate that critical limits are met, where corrective actions are predefined to enable swift action when things go wrong, thus preventing expansion of a food safety issue. All of the above activities are recorded and verified to ensure the system is operating as intended and to provide data to others (e.g., inspectors, auditors, management, new employees) to show that this is the case, recognizing that a HACCP Plan essentially addresses most of the requirements for process preventive controls.

However, the preventive controls process incorporates controls beyond those managed as process‐related CCPs in the HACCP framework. Therefore, such preventive controls address not only CCPs, but also controls for hazards related to food allergens, sanitation, suppliers and others requiring a preventive control. The preventive controls approach also recognizes that critical limits, defined by NACMCF as: “A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food‐ safety hazard” may not be required for some preventive controls. The broader term, parameters and values, supports identification of a frequency or other metric to assess compliance, rather than setting a precise minimum or maximum value to which a parameter must be controlled. i.e., immediate corrections (like re‐cleaning a line before start up) may be more appropriate than formal corrective action involving product risk evaluations for some preventive controls. Finally, the extent of validation activities (or demonstrating the controls actually work) may be less rigorous for some preventive controls than others.

Food Safety Plans

The Food Safety Plan is the primary document that guides the preventive controls for food safety system. The Food Safety Plan is developed using a systematic approach to identify those hazards that require preventive controls to prevent foodborne illness or injury. Nonetheless, it is a dynamic document, which must be kept current if changes are made to the system or to equipment when new products are added, or new hazards are identified. Food Safety Plan includes a number of elements such as hazard analysis, which is used to identify required preventive controls for the process, for sanitation, for food allergens and supply‐chain programs, where production process necessary to address the hazards requiring a preventive control. These given elements, along with a recall plan make up the Food Safety Plan. Many GMPs and other prerequisite programs are managed outside of the Food Safety Plan. While these are separate programs and may not require the same level of documentation as the elements of the Food Safety Plan, which are important. They are generally managed using standard operating procedures with documents and records kept as appropriate. Keep in mind that elements of GMPs that are not covered in the Food Safety Plan are still required by regulations, since most of the food production facilities required to build based on physical GMP requirements as primary requirement. Prevention‐based food safety management can be integrated into any operation; however, the process can seem complicated until the basic concepts are understood.

Developing a Food Safety Plan, including determining where preventive controls are required; involves a systematic process based on science to help ensure the safety of the product. The basic is hazard analysis, which is intended to identify hazards requiring a preventive control. When these hazards are known, preventive controls that are essential to prevent the hazard from causing illness or injury are to be identified. Thus, preventive controls may include process preventive controls, allergen preventive controls, sanitation preventive controls, supply‐chain preventive controls or other preventive controls that are essential for the product. Once preventive controls are identified, determination of relevant parameters that define the conditions which must be met to effectively manage the hazard. Monitoring, corrective action and verification procedures for each of the preventive controls identified must also be included in your plan as appropriate to ensure the effectiveness of the controls.

Monitoring provides documentation that demonstrates these conditions are met, where corrective actions or corrections are predefined to enable swift action when things go wrong, thus preventing expansion of a food safety issue. Once, things go wrong or out of control, it is necessary to clarify, if it was because a hazard was overlooked (in which case you must adjust the hazard analysis), or if a preventive control was not properly identified or implemented. All of the above is recorded and verified to ensure the system is operating as intended and to provide a record for others (e.g., inspectors, auditors, management) to show that this is the case. Some elements of a preventive controls system which are critical to the process also require validation to demonstrate that the controls actually work. This activity may be less rigorous for some preventive controls than others.

A recall plan is also a mandatory element of a Food Safety Plan when a hazard requiring a preventive control is identified. Nonetheless, system should have procedures to maintain implementation records to document that organization has implemented the given Food Safety Plan. Because your Food Safety Plan will be used or reviewed by regulators, employees, auditors, customers and potentially consultants, which may also be useful to include a brief description of the facility or company along with a list of Food Safety Team members, product descriptions, a process flow diagram and a process description to help people understand the structure of the plan.

Reference:

https://www.uvm.edu/extension/necafs/clearinghouse/resources/fspca-preventive-controls-human-food-participant-manual

https://en.wikipedia.org/wiki/Hazard_analysis_and_risk-based_preventive_controls

https://www.fda.gov/downloads/food/guidanceregulation/fsma/ucm584807.pdf

https://www.uvm.edu/extension/necafs/clearinghouse/resources/food-safety-plan-builder-preventive-controls

Safe Food for Canadians Regulations III

Benefits of Safe Food for Canadians Act 

The Safe Food for Canadians Act synchronize several parts of the legislation which includes the Canadian Agricultural Products Act, the Fish Inspection Act, the Meat Inspection Act, and the food provisions of the Consumer Packaging and Labelling Act. These acts were created during different time intervals due to their criticality to the food trade and consumer safety of Canadian citizens and trade. However, modern food safety and trade regulations require more comprehensive updated simplified systems than those of the pervious acts where Safe Food for Canadians Act bridges the gap while introducing  new tools to manage modern food safety risks, hence helping to simplify the process to ease the industry stakeholders. The synchronization will create a greater consistency in rules and regulations, while providing consumers with a safer food supply, where legislation will also create new export opportunities for Canadian producers, and enhance the protection of imported food commodities. Thus, new act has made Canadian food safety system stronger while reducing overlaps for Canadian food producers, where act provides industry with clear, consistent and straight forward inspection and enforcement rules so they can best meet their responsibility provide safe food for consumers. Further, act strengths Canada's world class food safety system while providing greater consistency for Canadian businesses, whether they produce food for the domestic or the international markets.

Traceability is the ability to track any food through all its stages of production, processing and distribution, which is an increasingly important element of food safety. Thus, legislation gives the CFIA the ability to develop innovative regulations to trace and to take action on potentially unsafe food commodities with more stringent controls on prohibition against selling food commodities that have been recalled. Nonetheless, the consumers will be safer from threats related to food commodity tampering, deceptive practices and hoaxes, where Government has new means to take swift action against these kinds of activities and to build additional safety into the food system through the food producer or importer to the consumer. Thus, applicable penalties and fines also increase to deter willful or reckless threats to health and safety.

In addition, adoption of the new act will provide more authority with clarity in rules and regulations for Canadian food commodity exporters and for trading partners importing food commodities to Canada. The newly introduced import control measures will help improve the existing import safety measures by clearly prohibiting the entry of potentially unsafe food commodities into Canada, where act has provisions to register or license importers, while binding them accountable for the safety of the food commodities they brought into the country. On the other hand, more countries are strengthening their import measures on food items in recent years, where they required that the foods imported be certified, reflecting a growing international effort to ensure food safety. Hence, the new legislation provides the CFIA the authority to certify all food commodities for export, allowing for a consistent approach to Canadian export certification. Nonetheless, new legislation has aligned Canada’s food safety system with its major trading partner USA, where the Food Safety Modernization Act will accept Safe Food for Canadians Act allowing Canadian export certification to provide more flexible, modern and timely responses to new international trade requirements. It also enables Canadian exporters to be more competitive abroad and open access to an even greater number of international markets by further aligning world class food safety systems with that of its key trading partners.

Major Changes to Previous Regulations

The new regulations include requirements of previous 17 parts including 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;

Organic Products.

Some of these requirements are 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. Nonetheless, SFCA also provides 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. Thus, flexibility to change the regulatory framework through an incorporated document whenever required, would allow the CFIA to make its 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. Incorporated documents that may change from time to time, but before making changes to internally generated documents; 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.

Exceptions and Exemptions

Any exception or exemptions are set out in the new regulations, based on an analysis of the food safety risk that may cause any hazardous effects to the general public. Hence, an exception from the written PCP requirements is proposed for some regulated parties that generate $30,000 or less in annual gross food sales (i.e. micro-sized businesses). However, this exception will not apply to regulated parties that slaughter food animals from which meat products for export or inter-provincial trade are derived, or that prepare meat products, dairy products, fish, eggs, processed egg products, or processed fruits and vegetables, or if an export certificate is requested.

Exemptions from licensing, preventive controls, and written PCP requirements are also proposed, unless an export certificate is requested, for

Alcoholic beverages;

Food additives; and

Some of the unprocessed foods that will be further prepared (e.g. grains, oilseeds, pulses and other foods such as green coffee beans and hops) before consumption. Such foods must be labelled with the words “For Further Preparation Only”, and may not be prepackaged food for consumers, which are listed in a schedule to the new regulations.

The new regulations would also include certain exemptions similar to those that exist in current federal regulations, such as food for personal use, food carried on any conveyance that is intended for the crew or passengers, or food for analysis, evaluation, research, or a food exhibition provided that the food is part of a shipment that weighs 100 kg or less or, in the case of eggs, is part of a shipment of five or fewer cases. Food that passes only in transit through Canada is exempt, provided the shipment travels in bonds.

Importation of non-compliant food or inter-provincial trade of non-compliant food to be subsequently brought into compliance (e.g. through relabeling the food) would be permitted provided that the food is imported by a license holder, is clearly labelled with “For Further Preparation Only” and is brought into compliance within three months from the day on which it was imported or traded inter-provincially, unless a longer time period is granted by the Minister.

Export

Under the SFCA, the Minister may issue export certificates, where new regulations would provide the process by which a regulated party may request an export certificate, if there is a requirements, i.e., fulfill a foreign government requirement. Nevertheless, exporters are permitted to meet foreign customer requirements that may differ from certain requirements of the new regulations. But those differences are required to be substantiated by documentation (e.g. a contract or a description of a foreign government requirement).

Membership Requirements for Buyers and Sellers of Fresh Fruits and Vegetables

The Licensing and Arbitration Regulations were cancelled, where new regulations require that buyers and sellers of fresh fruits and vegetables be members of the Fruit and Vegetable Dispute Resolution Corporation (DRC) to obtain an exemption from the trade of fresh fruit or vegetable provisions in Part 2, Division 2 of the new regulations. The DRC is a non-profit, membership-based organization serving the produce sector that offers dispute resolution services (e.g. mediation and arbitration) to its members, where over 80% of fresh fruit and vegetable buyers and sellers are already members of the DRC.

Meat

Changes to previous requirements for meat will increase the alignment with requirements for other foods regulated by the CFIA to the extent possible given meat-specific food safety risks, i.e. previous mandatory inspection requirements for all imported meat products has been removed, and replaced with targeted inspection requirements based on risk. Nonetheless, mandatory licensing of meat storage facilities also removed except for persons who would handle and store imported meat products for inspection.

Exemptions for some existing meat product–specific requirements are introduced for meat products, i.e. frozen pepperoni pizza; that contain a mixture of ready-to-eat meat and other non-meat ingredients, which are treated as more similarly to all other prepared foods.

Recognition of Foreign Systems

The new regulations prescribe the standards to be met for the minister to recognize a foreign system of inspection for meat products and shellfish, and to recognize systems for preparing meat that are used in meat product establishments. The new regulations also provide for circumstances in which ministerial recognition must be suspended or cancelled. On the other hand, systems that are recognized under the MIA or FIA will be continue to be recognized under the new regulations.

Ministerial Exemptions

The authority for the minister to exempt food from requirements for the purpose of test-marketing a food that is new or of alleviating shortages has been expanded to all foods. Thus, ministerial exemptions can be granted only when they would not result in a risk of injury to human health and, with regards to test-market exemptions, when they would not confuse or mislead the public or disrupt the normal trading patterns of industry or the normal patterns of food pricing.

Inspection Legends

Provisions related to inspection legends that existed in previous commodity-specific regulations made under the CAPA, where the FIA and the MIA will be carried over as usual under the new regulations.

Container Sizes and Standard Weights

Requirements for standard weight and container sizes that previously existed in commodity-specific regulations under the CAPA, the MIA, the FIA and the CPLA have being included in the new regulations.

Labeling and Standards of Identity

The new regulations has made some changes to requirements relating to labeling and standards of identity provisions, i.e. for processed eggs, where new changes has grouped similar provisions together and reduced duplication and differences where possible.

Labeling provisions have being included in the body of the new regulations whereas standards of identity has incorporated by reference in the new regulations and maintained by the CFIA (in accordance with CFIA’s Incorporation by Reference Policy).

Previous requirements of the CPLA and its regulations apply to prepackaged food sold in Canada, including food sold within a province, which has been included in the new regulations. The intra-provincial application of these requirements will be maintained.

Grade Requirements

Grade requirements in previous regulations have been consolidated into two documents, which has being incorporated by reference in the new regulations:

1.           The new Beef, Bison, and Veal Carcass Grade Requirements shall be maintained by the Canadian Beef Grading Agency (CBGA) according to conditions outlined in a Memorandum of Understanding between the CBGA and the CFIA; and

2.           The new Canadian Grade Compendium would consolidate all other Canadian grade requirements in a single document organized by commodity and maintained by the CFIA.

Organic Products

Under the Organic Products Regulations, 2009, only the producers of organic products and anyone labeling and packaging organic products are required to be certified. Thus, new regulations has expand certification to include other service providers to allow organic integrity to be maintained along the entire supply chain. In addition, the new regulations has included the organic certification of aquaculture products too.

Reference

http://www.inspection.gc.ca/about-the-cfia/acts-and-regulations/regulatory-initiatives-and-notices-of-intent/sfca/overview/eng/1339046165809/1339046230549

http://www.gazette.gc.ca/rp-pr/p1/2017/2017-01-21/html/reg1-eng.html

http://www.gazette.gc.ca/rp-pr/p2/2018/2018-06-13/html/sor-dors108-eng.html

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

https://globalfoodsafetyresource.com/safe-food-for-canadians-act-an-overview/

http://inspection.gc.ca/about-the-cfia/acts-and-regulations/regulatory-initiatives/sfca/eng/1338796071420/1338796152395

https://www.sgs.com/en/news/2017/03/safeguards-03517-cfia-publishes-the-proposed-safe-food-for-canadians-regulations

https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html

https://canadabusiness.ca/blog/exporting-food-under-the-new-safe-food-for-canadians-regulations/

https://www.canada.ca/en/food-inspection-agency/news/2018/11/t-he-government-of-canada-marks-two-months-until-the-safe-food-for-canadians-regulations-come-into-force.html

Safe Food for Canadians Regulations

Overview of Safe Food for Canadians

Today is the day that the Safe Food for Canadians Regulations is coming to effect the food industry in Canada and their trading partners around the world. Canada has one of the best food safety regulations and food systems where they have act as frontiers in food safety from the very beginning. Hence, Safe Food for Canadians Regulations are the result of an unprecedented level of consultation with the agriculture sector and other stakeholders, which will enhance Canada’s reputation as a global leader in food safety, while expanding market access for Canadian food products. Canada is the fifth largest exporter of agriculture and agro based food products in the world, where maintaining and enhancing the strength of the export markets is vital to achieving the Government of Canada's trade target of growing agriculture and agro based food exports to $75 billion by 2025. Thus, Safe Food for Canadians Regulations (SFCR) will further enhance Canada's international reputation as a global leader and help maintain access to the United States and other key markets, as well as potentially open up new trade opportunities. Because many countries, such as Canada, USA, UK, Australia, New Zealand, EU, etc., are requesting companies moving food into and out of those countries to comply with increased food safety restrictions and traceability measures. This means that programs such as Transparency-One and expertise in auditing or evaluating food safety programs have become a necessity, not a luxury. Additionally, the training of personnel to develop and oversee employees that work in these programs becomes necessary, since the license in Canada will be connected to compliance and failure to comply may result in the license being revoked.

Background

Recent decades have seen significant changes in the global food environment due to the advances in science and technology, the emergence of highly integrated food supply chains and changing consumer preferences which require Canada’s federal food regulatory system to keep pace in order to protect the health of Canadians. Thus, expanding global marketplace for food commodities has created more opportunities for the introduction and spread of contaminants that may put Canadian food safety at risk. Hence, food-borne illnesses continue to impose significant health and economic costs on Canadians and recent food safety incidents in Canada have demonstrated where the current federal food regulatory framework must be strengthened. This framework must also keep pace with prevention-focused based on international food safety standards so that Canadian food exporters have access to foreign markets and remain competitive internationally. Currently, foods prepared in Canada or imported into Canada are not all subject to the same regulatory requirements, and some food safety requirements do not reflect advances in technology, science and food safety best practices.

The New Regulation Requirements

The new consolidated regulations are based on international food safety standards, which are also the basis for modernized food safety regulations that have been, or are being, adopted by Canada's key trading partners, including the United States, the European Union, Australia and New Zealand. Hence, under the new consolidated regulations, Canadian Food Inspection Agency (CFIA) will also have broader authority to certify that Canadian food products were manufactured safely, which were previously, not been accessible for certain types of processed and manufactured foods including some export markets, because the CFIA did not have the authority to issue export certificates for certain products, including manufactured products such as cookies and potato chips for example.

In June 2018, the Government of Canada announced the Safe Food for Canadians Regulations, which will protect Canadian families by making the food system even safer by focusing on prevention and allowing for faster removal of unsafe food from the marketplace. Thus, Safe Food for Canadians Regulations will reduce unnecessary administrative burden on businesses by replacing 14 sets of regulations with one, and will help maintain and grow market access for Canada's agri-food and agricultural sector. Depending on the food commodity, type of activity and business size, compliance with some requirements will be necessary immediately on today (January 15, 2019) while others will be phased in over the following 12-30 months. As to the new regulations, that will require food businesses who import or prepare food for export or to be sent across provincial or territorial borders to have licenses, as well as preventive controls that outline steps to address potential risks to food safety. They will also help reduce the time it takes to remove unsafe food from the marketplace by requiring businesses to trace their food back to their supplier and forward to whom they sold their products. These new regulations, once in force, would provide more modern and consistent requirements for all foods imported, exported and traded between provinces by consolidating and streamlining requirements from several pieces of existing legislation and across sectors and introducing an outcome-based approach to food safety rules, where possible.

Benefits

The newly introduced Safe Food for Canadians Regulations would strengthen Canada’s reputation as a leader in food safety by establishing consistent, prevention-focused requirements for food that is imported or prepared for export or interprovincial trade, and would also include some requirements applicable to food that is traded intra-provincially. The proposed Regulations would consolidate 13 food commodity-based regulations plus the food-related provisions of the Consumer Packaging and Labelling Regulations (CPLR) into a single and more outcome-based food regulation under the Safe Food for Canadians Act (SFCA). Some requirements for certain food sectors would be phased in to reflect business size and different levels of industry readiness. Plain-language tools and guidance would be provided to support small businesses that are involved in importing food, or preparing food for export for interprovincial trade, in meeting the requirements.

The estimated benefits of the proposed requirements would have an annualized value of approximately $137.3 million. These benefits would be associated with the traceability of food and the licensing of businesses as well as the consolidation of food regulations. In comparison, the estimated costs of the proposed requirements would have an annualized value of approximately $138.2 million. These costs would be associated with the use of preventive controls (i.e. food safety requirements) and preventive control plans, the traceability of food, the licensing of businesses and the Canadian Food Inspection Agency (CFIA) regulatory implementation. The estimated net annualized benefit (i.e. benefits less costs) of these impacts would be approximately –$0.9 million.

In addition to these estimates, other qualitative benefits would include a reduction in food safety risk for consumers, a more level playing field for Canadian businesses, increased international and domestic regulatory alignment, and sustained market access for Canadian exports. It will also expand the CFIA’s food safety regulatory coverage, bring a consistent and more effective approach to inspection and oversight for food safety by the CFIA, and enhance Canada’s reputation as a global food safety leader.

The “One-for-One” Rule would apply. The estimated total administrative cost increase would have an annualized value of approximately $11.4 million. The small business lens would apply and the CFIA would provide a flexible option for small businesses that are involved in importing food, or preparing food for export or for interprovincial trade. As a result, the estimated total cost savings for these small businesses from the flexible option would have an annualized value of approximately $53.2 million.

The proposed Regulations would be well aligned with similar modernization efforts among Canada’s key trading partners. In addition, the proposed Regulations would provide a foundation for consistent federal oversight of food that better reflects internationally recognized food safety practices.

How the New System Works?

The new consolidated regulations are enforced from now on, where the CFIA will publish a list of SFCR-licensed food manufacturers to confirm that they are operating in compliance. To be considered in good standing under the SFCR, food businesses will need to have an acceptable preventive control plan and traceability records. Being included on the list will help food businesses maintain access to key markets, including the United States. Once the Safe Food for Canadian Regulations are fully in force, Canadian food businesses exporting foods that are regulated by the U.S. Food and Drug Administration can leverage their SFCR license to demonstrate that their food safety controls meet the U.S. importers' requirements under the U.S. Foreign Supplier Verification Program (FSVP). Under the U.S. Foreign Supplier Verification Program, the U.S. importer can refer to the list of SFCR-licensed Canadian food businesses to meet the U.S. FSVP rules.

Canada and the U.S. have a Food Safety Systems Recognition Arrangement (FSSRA), which recognizes that the two countries have comparable food safety control measures. Canadian food that can be qualified under the FSVP through the FSSRA includes:

Fruit and vegetables

Shelled eggs

Dairy (except Grade "A" milk and Grade "A" milk products)

Fish (except farmed catfish, catfish products and molluscan shellfish)

Maple

Honey

Other foods (such as snacks, cereals, and bakery products)

The United States has recently made it a requirement for all Canadian businesses that ship food to the US to meet their new food safety standards. The Safe Food for Canadians Regulations will permit Canadian food businesses to acquire a license that demonstrates that they meet the requirements under the U.S. Foreign Supplier Verification Program and continue trading with the U.S. Businesses that require a license will have to attest that they have preventive controls in place (such as sanitation and pest control measures) and businesses with $100K or more in annual sales will have to prepare a written prevention control plan. Businesses are encouraged to enroll now in My CFIA and be prepared to apply for their license when it becomes available. My CFIA is a convenient and secure way to do business with the Canadian Food Inspection Agency (CFIA), which is enforcing businesses to use it online platform and discouraging the traditional uses such as emails or fax applications. Businesses can manage and track service requests online, including permissions such as licenses, permits, registrations and export certificates. The CFIA is sharing information with industry in face-to-face sessions across the country as well as through webinars, which will help businesses to easily adapt the new regulations. 

References

https://globalfoodsafetyresource.com/safe-food-for-canadians-act-an-overview/

http://inspection.gc.ca/about-the-cfia/acts-and-regulations/regulatory-initiatives/sfca/eng/1338796071420/1338796152395

https://www.sgs.com/en/news/2017/03/safeguards-03517-cfia-publishes-the-proposed-safe-food-for-canadians-regulations

https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-108/index.html

https://canadabusiness.ca/blog/exporting-food-under-the-new-safe-food-for-canadians-regulations/

https://www.canada.ca/en/food-inspection-agency/news/2018/11/t-he-government-of-canada-marks-two-months-until-the-safe-food-for-canadians-regulations-come-into-force.html