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


Tuesday, January 15, 2019

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