A New Regulatory Framework for Federal Food Inspection: Discussion Document
Ensuring industry commitment to food safety is important in enabling effective oversight of the safety of food consumed by Canadians. Licences assist in identifying who is preparing food commodities destined for inter-provincial trade or importing food commodities into Canada, where these regulated parties are located and what activities they are conducting in relation to a food commodity. Licensing would be an additional tool in the food safety regime. It allows the Minister to authorize a regulated party to conduct an activity and, where relevant, to attach specific conditions to the activities.
Building on the Improved Food Inspection Model, the new licensing regime will help enhance the CFIA's surveillance schemes and food safety inspection activities. Furthermore, this new regime will contribute to improved risk-based inspection oversight which will be used to streamline inspection priorities, and improve emergency management.
Licensing and registration requirements currently exist under CAPA, FIA and MIA. The definition of food commodity in the SFCA is broader than the definition of "agricultural product" under CAPA, "fish" under FIA and "meat product" under MIA. The proposed regulations would, therefore, extend licensing requirements to encompass all regulated parties who import food commodities or prepare them for inter-provincial trade. This means that some regulated parties that prepare food commodities destined for inter-provincial trade that are not currently regulated under CAPA (e.g., cookies, cake mixes) would now be required to have a licence under the SFCA. Also, all importers of food commodities would now be required to be licensed. The CFIA is proposing to no longer register establishments as licence holders would be subject to requirements related to the establishment where the food commodity is being prepared.
Voluntary licence applications would be permitted by regulated parties not subject to licensing requirements under the proposed regulations (e.g., regulated parties solely trading food commodities within a province). If a licence were to be issued, the licence holder would be subject to all requirements of the SFCA and its regulations.
In the context of the consultations in relation to the Improved Food Inspection Model, it had been proposed that all licence holders should have an address in Canada. This approach has raised some concerns in relation to companies that import food commodities into Canada but are not located in Canada. CFIA is considering conditions under which non-resident importers might be permitted.
- A licensing requirement is being proposed for any regulated party who imports food commodities or prepares food commodities for inter-provincial trade. The licence would be valid for two years. Licence holders would be required to apply for the renewal of their licence prior to expiry, including payment of applicable fees.
- Regulated parties would have the option of applying for a licence per establishment or per activity (for example, import, prepare, etc.) or a single licence which would cover all of their operations in multiple establishments and/or multiple activities. Of note is that if a single licence is issued for multiple establishments or activities one must be aware that the suspension or cancellation of the licence would affect all of the establishments and/or activities subject to the licence.
- There may be special cases where the requirement to have a licence may not apply (e.g., food imported for industrial uses) or where special conditions may be applied to licence holder given the nature of the business (e.g., food brought into compliance after entry into Canada).
- The Minister may refuse to issue or renew a licence if the applicant does not meet the requirements of the SFCA and its regulations, has provided false and misleading information, or has outstanding unpaid fees.
Question 1: The Government is seeking comments on the proposal to move away from the registration of establishments and instead require a licence for those responsible for the preparation of food.
Question 2: In certain cases, modified licence requirements for specific activities and products may be warranted. Please describe any cases that justify these modified requirements.
Question 3: Currently, some programs allow for importers that do not have a Canadian address (Non-Resident Importer). What are your views on whether non-resident importers should be permitted for licensing? How might the regime accommodate non-resident importers?
Food commodities exported from Canada are exempt from the requirements of the FDA, provided that (a) the package is marked for "Export" or "Exportation" and (b) a certificate that the package and its contents do not contravene any known requirements of the law of the importing country has been issued. Any additional requirements that are set under the new SFCA will not impact that exemption.
Those who export food commodities from Canada need to meet the requirements of the country of import. Some importing countries require that food commodities be prepared in accordance with Canadian requirements, others have specific requirements for the food commodities they allow for import, while some others have no requirements. In certain cases, importing countries may require the government of the country of origin to certify the safety or other attributes of a food commodity, before the importing country will accept the shipment.
The SFCA provides the authority to the Minister to certify food commodities for export. It also allows for the licensing of regulated parties who export food commodities or prepare them for export. The Improved Food Inspection Model proposed that all exporters should be licensed and have preventive control plans in place to meet importing country requirements. As CFIA now considers making the export licence a legal requirement, additional issues have been raised such as the benefit derived from licensing all exporters relative to the costs this would entail.
There are many possible approaches to regulating the export of food commodities and the Government is seeking input on these possible approaches. These range from approaches that require full oversight of exports, to those that respond only to the demands of Canadian exporters and the importers of their food commodities, to no oversight. Licensing of exporters who are required to adhere to Canadian requirements or who require an export certificate to access markets could allow for a more efficient approach to providing assurance to trading partners that food meets their requirements. In choosing among these approaches, there are a number of factors that must be taken into account, including:
- Cost to the exporter (e.g., administrative burden, time delay, fees)
- Benefit to the exporter (e.g., value of access to markets)
- Cost to Canada (e.g., cost of the inspection system to the Government of Canada – and hence the Canadian taxpayer, cost of inability to access markets)
- Benefits to Canada (e.g., value of access to markets)
Regardless of whether or not exporters are licensed, exported food commodities will need to meet some basic Canadian labelling requirements (e.g., common name, net quantity and lot code). Such requirements are necessary for adequate identification and traceability of food commodities being exported.
Question 4: Should exporters or those who prepare food commodities for export be required to hold a licence issued by the Minister? Why or why not?
Question 5: What requirements should a licensed exporter need to meet?
Question 6: Should those who need the Minister to certify their food commodities for export be required to hold a licence, or should the Minister handle these requests on an ad hoc basis? What would be the value of a licence in this scenario?
A licence application must be made to the Minister. The proposed regulations would require that an approved application form be used and be accompanied by the applicable fee that would be prescribed in the Canadian Food Inspection Agency Fees Notice.
The information contained in the licence application would be used by the Minister to issue a licence. It will also assist the CFIA to assess the risks associated with the food commodity and/or processes. Some of the information that could be required as part of the application may include; contact and legal information (name, physical location, address/contact info where records will be available, etc.), activity related information (type of activity, size of business, number of employees, etc.), and commodity related information (commodity type, volume of production, countries from which products are typically imported, consumers to whom products are typically sold etc.). Licence holders would also be required to attest that they have a preventive control plan in place that is suitable to their operation.
The Government is also considering requesting as part of the application a Canada Revenue Agency's Business Number, if available. This number is increasingly being accepted as a common client identifier for businesses to simplify their dealings with federal, provincial and municipal governments. While in the short-term it will provide an extra measure of assurance for CFIA, in the future it holds potential for seamless integration, improved identity management, on-line transactions and improved electronic service for Canadians.
Suspension and Cancellation of a Licence
Under the SFCA, the Minister has the authority to suspend or cancel a licence. The proposed regulations would include grounds for the suspension and cancellation of a licence.
The Minister may suspend a licence if:
- The licence holder has not complied with the conditions of the licence or any provision of the Act or Regulations
- The licence holder has unpaid fees
- It is reasonable to believe that public health may be endangered if the licence holder continues to conduct the authorized activity
The Minister may cancel a licence if:
- The licence was issued on the basis of false or misleading information, or false or falsified documents submitted in or with the application;
- The reason for the suspension cannot be resolved within 90 days following the day on which the licence was suspended. When the reason for suspension cannot be resolved within 90 days, a longer time period may be granted upon request of the licence holder;
- The licence holder has continued to conduct the authorized activity while their licence is under suspension.
Question 7: What are your views on the grounds for the suspension or cancellation of a licence?
Question 8: The Government is considering imposing a 2 year period after a licence cancellation, during which a regulated party would be unable to apply for a licence. Do you agree with this? Please explain your response.
Preventive Control Plan
A preventive control plan (PCP) is a written document that sets out how food safety and other regulatory requirements (e.g., labelling, product composition, etc.) will be achieved. PCPs are recognized internationally as the best way to demonstrate that food safety risks and hazards are controlled or eliminated because they focus on prevention and systems-based examination of operations by regulated parties. PCPs will address not only food safety requirements but will also address other requirements such as net quantity and grades.
The proposed regulatory framework for food proposes to reduce, where appropriate, the current prescriptive commodity-specific requirements, by moving to a system of requirements that articulates the expected outcomes as it relates to food commodities.
Proposed outcome-based regulatory requirements are included in Annex 1. They are based on HACCP principles, consistent with international standards such as Codex Alimentarius and were guided by the Improved Food Inspection Model with respect to scope, language and element requirements. The regulations of key trading partners, such as Australia, New Zealand, the United States, the European Union, were also considered in developing this proposal.
Depending on the licence holder's operation and activity, they will have to address some or all of the following regulatory requirements:
- Processes and products
- Sanitation and pest control
- Hygiene and competencies
- Equipment design and maintenance
- Physical structure and maintenance
- Receiving, transportation and storage
- Recalls, complaints and record-keeping
It should be noted that importers, at a minimum, must address the regulatory requirements for Process and products (1) and Recalls, complaints and record-keeping (7). In addition, importers who are involved in handling or repackaging of food must address all of the above regulatory requirements (1-7) that apply to their activities.
The Improved Food Inspection Model identifies certain operations not subject to licensing. Such operations include, for example, transporters of food commodities as well as facilities that store food commodities but that are not involved in importing, exporting or preparing food commodities. Although it is recognized that such important operations in the food chain may not necessarily require a PCP of their own, such operations will need to be included in the PCP of the licence holder in order to address hazards and risks that are likely to occur during transportation and storage, which can impact the safety and compliance of their food commodities.
PCPs can be adapted to the risks and complexity of operations but must address the applicable regulatory requirements. It is the responsibility of the regulated party to ensure that effective controls and precautions are in place to address potential hazards and risks associated with their food commodities and processes, as well as to consider what they would do in the event that something went wrong.
The proposed regulations contribute to enhanced food safety and regulatory compliance by requiring that all licence holders develop, implement and maintain a PCP . Consequently, licence holders must demonstrate in their PCP how they achieved compliance with regulatory requirements and that they have appropriate systems to mitigate risks posed by their operation. Hence, licence-holders should describe how they control their operations, including how they monitor, verify and correct problems, and respond to unforeseen food safety and non-compliance situations.
Anyone who imports or prepares food commodities destined for inter-provincial trade is required to develop, document, implement, and maintain a PCP adequate to their activities.
The PCP would involve a systematic examination of operations to identify potential food safety hazards, which may reasonably be expected to occur in the preparation of food commodities, along with their corresponding controls. Furthermore, hazards that may lead to non-compliance with regulatory requirements but that are not food safety in nature must also be considered and controlled. The PCP would also outline monitoring and verification procedures, corrective actions, management review (review procedures by the licence holder), record keeping and traceability procedures. Hazard Analysis and Critical Control Point (HACCP) is the internationally accepted system adopted by the joint WHO/FAO Codex Alimentarius Commission. Some sectors have already implemented PCPs, based on HACCP principles, to demonstrate how they achieve compliance [for example, voluntary Food Safety Enhancement Program (FSEP), Quality Management Program (QMP)] and would be able to transition to the new model with little adjustment.
To facilitate the transition to an outcome-based approach, the Agency will provide guidance material to regulated parties with options or model designs, and the performance measures that will help them achieve the desired outcomes. A model system for compliance is a non-binding model that provides guidance to a regulated party to meet a specified outcome. Model systems set out practices and procedures for premises and equipment that, when implemented, would facilitate compliance.
The proposed outcome-based approach provides regulated parties with flexibility to introduce new technologies, processes, and procedures that could enhance safety and/or reduce costs, rather than having regulations prescribe specific methods and processes. Likewise, it allows the CFIA to better adjust its oversight to changes in science, technology, and the risk environment. In addition, it holds promise in greater collaboration with regimes in other jurisdictions which require similar outcomes, both within Canada and abroad. CFIA has prepared a policy document entitled "Foundation of an Outcome-Based Approach" to guide the use of this approach.
Question 9: Are the proposed outcome-based regulatory requirements in Annex 1 sufficiently clear for industry to understand what outcomes they will need to achieve and their regulatory responsibility?
Question 10: Is there anything missing in the requirements that should be addressed to ensure food safety?
Question 11: Industry is responsible for safe food and meeting regulatory requirements. The CFIA will be developing a suite of guidance documents. How could CFIA assist industry in meeting these outcomes through guidance documents, or other tools/methods?
Question 12: To address potential unforeseen emerging issues that would not be covered by a standard hazard analysis process but may have an impact on public safety, should PCPs also include a requirement for regulated parties to routinely consider how to make their food safety approaches resilient in the face of new emerging threats?
Additional food safety requirements which outline some prohibited practices are addressed in sections 4 to 19 of the Safe Food for Canadians Act (SFCA). The proposed regulations will include additional prohibitions that currently exist in the regulations under CAPA, FIA, and MIA and are fundamental to ensuring the safety of food products.
A person must not import, export, or send or convey a food commodity from one province to another unless the food commodity, including its components and ingredients,
- is not contaminated;
- is edible;
- is prepared under sanitary conditions; and
- meets all other requirements of the Food and Drugs Act and the Food and Drug Regulations.
A person must not mix a contaminated food commodity with another food commodity that is not contaminated for the purpose of bringing the finished product into compliance with the requirements without further processing.
Under the proposed regulations, all importers will be required to have a licence and a preventive control plan demonstrating that the food commodities they import meet Canadian requirements. This is a substantial new requirement that seeks to assure that domestically produced and imported food commodities are held to the same food safety standards.
Equivalence or comparability means that the foreign country's system does not have to be the same as Canada's food inspection system, but is based on the ability of an exporting country's system or a sanitary measure to achieve the same outcome or provides for the same appropriate level of protection as Canada's system or sanitary measure.
Equivalency agreements, or recognition of foreign food safety systems, may provide additional "assurance" that food commodities imported into Canada meet regulatory requirements. While system recognition would not eliminate the need for licences, it could reduce the burden on importers who import from countries that have been deemed equivalent and facilitate oversight of imports.
Based on risk and available resources, the CFIA may choose to perform onsite foreign system audits to review the food safety requirements imposed by a foreign country on their domestic manufacturers. The CFIA is developing a policy to guide the application and determination of foreign system recognition and equivalency agreements.
Question 13: What criteria could be used as a basis for foreign system recognition? What benefits or risks exist with such recognition that need to be taken into account in regulations or program design?
Question 14: The current regulations for egg, dairy and meat products require that imports can only be from countries with equivalent food safety systems. Given the proposed requirement on importers to have a licence and a PCP , are equivalency provisions still needed for these commodities? Please explain.
Rapid identification of the origin and movement of a food commodity is essential for protecting consumers during a food safety incident. This process requires that accurate information about the food commodity be available to regulated parties and the CFIA in a timely and accessible manner.
While many regulated parties in the food sector have implemented voluntary traceability systems, others do not have the necessary record-keeping practices to facilitate timely food safety investigations, recalls or withdrawals. The resulting information gaps within the food supply chain may lead to a less efficient response to a food safety incident.
The international standard for traceability established by Codex Alimentarius calls for tracking of food commodities forward to the immediate customer and trace materials/food commodities backwards to the immediate supplier ("One step forward, one step backwards").
The proposed regulations would, at a minimum, apply the Codex standard to every stage of the food supply chain, from production to retail. Although many regulated parties have already implemented a traceability system that meets the Codex standard, all regulated parties are encouraged to adopt this practice now, in advance of the legal requirement to do so, to align with the proposed regulations. Retailers may be covered by the proposed traceability regulations but would not be required to trace food commodities sold to the final consumer.
- Anyone who imports, exports or prepares food commodities would be required to maintain specified traceability records to facilitate the tracing of the physical flow of food commodities to the immediate customer (except when food commodities are only sold to the final consumer) and tracing the physical flow of food commodities backwards to the immediate supplier.
- These records would need to be provided to an inspector on request, in a format defined by the CFIA, within 24 hours. If provided in an electronic format, the records would need to be un-encrypted and provided in a format that could be imported and manipulated by standard commercial software.
Question 15: What are your thoughts on the proposed traceability requirements?
Accurate and up-to-date records are crucial for the ability to respond to a food safety incident in a timely manner.
Specified records shall be prepared, kept, maintained and provided, in English or French, and be available in Canada for a period of three years.
Question 16: What are your comments on the proposed record keeping requirements? Should the requirement be limited to record availability?
The CFIA Act provides authority to order a recall. The SFCA amends the CFIA Act to include a new regulation making authority respecting the recall of products. Hence, new regulations will be proposed under the CFIA Act for the recall of products, which may include requirements to notify customers and suppliers.
Currently, under CAPA, FIA, MIA and CPLA, inspectors have the authority to seize (take legal control of a thing) and detain (maintain legal control over a seized thing) anything that is believed to be in contravention of the Act or regulations. This authority also exists in the SFCA.
- A notice of seizure and detention would need to be delivered to the owner of the thing seized, or the person having possession, care or control of it at the time of its seizure, and would need to include the following:
- the detention tag identification number;
- the quantity of seized thing, if applicable;
- a description of the thing seized;
- the reason for the seizure and detention;
- the date of the seizure and detention;
- the name of the owner or person having possession, care or control of the seized thing, and contact information, in block letters;
- the location of the seized thing
- the name and contact information of the inspector.
- Unless authorized by an inspector, no person other than an inspector would be able to alter, deface or remove a detention tag from something that had been seized or detained.
- To maintain the integrity of the food commodity during the period of detention, the owner of the thing seized, or person having possession care or control of it at the time of seizure, would need to ensure that the seized food commodities are stored under conditions appropriate to the preservation of the food commodity.
- An inspector who releases a thing seized would need to provide a notice of release to the person to whom a copy of the notice of seizure and detention was delivered.
In addition to the authority to seize and detain, the SFCA also provides authority to the inspector to order the owner or the person having possession, care or control not to move an item or to restrict its movement for any time that may be necessary.
- An inspector who orders not to move an item or to restrict its movement pursuant to the inspection authority in the SFCA may attach to the item a tag, upon which would be clearly written:
- the word "held";
- a held tag identification number;
- a brief description of the item held;
- the date of the order;
- the name and contact information of the inspector, and
- the signature of the inspector.
- Unless authorized by an inspector, no person other than the inspector would be able to alter, deface or remove a "held" tag attached by an inspector.
- Where an inspector is satisfied that it is no longer necessary to hold the item and where a held tag has been attached to the item, a release would be delivered to the owner or person having possession, care or control of the item at the time of the order.
The proposed regulations would require everyone importing or preparing food for inter-provincial trade to be licensed and comply with all the requirements of the Act and regulations, including labelling, packaging and standards requirements. Imported food commodities would need to be accompanied by all required import documentation and meet regulatory requirements.
Some regulated parties currently import food commodities that are not compliant with Canadian requirements, but subsequently bring them into compliance prior to being offered for sale. This practice is particularly used to correct a non-compliance related to product labelling and often on products for smaller market segments. Other food commodities, such as spices, are imported into Canada for further processing before sale to Canadians.
It is proposed that such food commodities would not be subject to regulatory requirements at the time of import if they are clearly labelled with, for example, "For further processing only, "Not for human consumption", "Not for sale in Canada".
Currently in CAPA, FIA, and MIA, there are a number of situations where regulations do not apply to the import, export, or inter-provincial trade of a food commodity, including those solely for personal use (sometimes with commodity specific limits to amounts); items carried on any vessel, train, motor vehicle, aircraft or other means of transportation for use as food commodity for the crew or passengers; imported from the United States into the Akwesasne Reserve for use by an Akwesasne resident; part of an immigrant's or an emigrant's effects; being sent or conveyed from one federal penitentiary to another; to be used solely for scientific analysis, a trade show [national or international exhibition] or business-to-business market analysis, or food commodities not intended for human consumption.
Question 17: Do you think the situations outlined above where regulations would not apply to the import, export, or inter-provincial trade of a food commodity should be maintained? Are there any other situations you can envision where the regulations should not apply?
Question 18: Sometimes food commodities are imported into Canada solely for export to a third country, or "trans-shipped" through Canada, and are not offered for sale in Canada. In these cases, should these shipments be exempt from the application of the Act and the Regulations? Why or why not?
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