Operational guideline: Assessing, monitoring and documenting the disposition of non-compliant food

On this page

• 1. Purpose
• 2. Authorities
• 3. Reference documents
• 4. Definitions
• 5. Acronyms
• 6. Operational guideline
  • 6.1 Assessing the proposed disposition method
  • 6.2 Monitoring the disposition
    • 6.2.1 Authorizing the movement or alteration of a seized product
    • 6.2.2 Witnessing the disposition
  • 6.3 Documenting the disposition
    • 6.3.1 Collecting information to document the disposition
    • 6.3.2 Recording the information in the relevant data capture system
    • 6.3.3 Additional guidance for documenting disposition of food identified during a food safety investigation or recall
  • 6.4 Closing the disposition case
• 7. Appendices
  • Appendix A: Considerations when assessing the suitability of a food disposition method intended to correct non-compliance for future sale as human food in Canada or export
  • Appendix B: Considerations when assessing a disposition method intended to remove the food from human use in Canada (export of non-compliant food, destruction, disposal)

1. Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) inspection staff on assessing, monitoring and documenting the disposition of food that may pose a health risk or is unsafe, hazardous or otherwise non-compliant to the Safe Food for Canadians Act, the Food and Drugs Act or their regulations. This document is not intended to cover disposition under section 123 of the Safe Food Canadians Regulations.

This document is intended to be used in conjunction with other guidance documents as referenced in section 3.0.

The guidance outlined below should be used whenever CFIA becomes aware of a non-compliant food identified, for example, during food safety investigations, recall effectiveness checks, complaints follow up or a product inspection, regardless of whether the food is in distribution or not.

2. Authorities

• Safe Food for Canadians Act (SFCA)
• Safe Food for Canadians Regulations (SFCR)
• Food and Drugs Act (FDA)
• Food and Drug Regulations (FDR)

The inspection powers, control actions and enforcement actions authorized by the above legislation are identified and explained in the Operational guideline – Food regulatory response guidelines.

3. Reference documents

• Policy on the export of non-compliant food
• Standard Inspection Process
• Standard regulatory response process
• Food incident response process
• Operational guideline: Food regulatory response guidelines
• Operational Procedure: Procedure for seizure and detention, authorizing movement and disposition
• Operational guideline: Inspection of evidence showing that control measures are effective
• Operational procedure: Ordering removal, or destruction of unlawful food imports
• Visual examination of commercially sterile low-acid and acidified low-acid foods packed in hermetically sealed containers
• Issues Management System (IMS) User Manual (accessible only on the Government of Canada networks - RDIMS 1599661)
• Digital Service Delivery Platform Standard Operating Procedure (DSDP SOP) Managing a Non-Compliance (accessible only on the Government of Canada networks – RDIMS 9906406)

4. Definitions

Unless specified below, definitions are located in the:

• Safe Food for Canadians Regulations: Glossary of key terms
• My CFIA Glossary of Terms

Disposition

Any action taken on an affected food to bring it into compliance or to remove it from the Canadian marketplace, such as relabelling, reworking, culling, exporting and destruction

5. Acronyms

Acronyms are spelled out the first time they are used and are consolidated in the Food business line acronyms list.

6. Operational guideline

The regulated party is responsible for ensuring that non-compliant or unsafe food does not enter or re-enter the food distribution chain.

The CFIA inspector reviews the method of disposition proposed by the regulated party to ensure this method will not pose a risk of contamination to current and future food, animal feed systems and water sources (for example, comply with municipal by-laws for waste disposal and regulations concerning animal feed). The regulated party is responsible for implementing the method of disposal authorized by CFIA.

It is recommended that the inspector consult feed advisory staff when evaluating if a disposition method will impact the animal feed system. When considering disposition methods for imported food that has been ordered removed or destroyed pursuant to SFCA 32(1), consult the Operational procedure: Ordering removal, or destruction of unlawful food imports.

6.1 Assessing the proposed disposition method

When a non-compliance is identified, the regulated party may need to take corrective actions to address the non-compliance or CFIA may order the food to be removed from Canada (in the case of an imported food) or destroyed. If multiple options are available to correct the non-compliance, the regulated party may propose a method of disposition. If that is the case, perform the following steps:

1. Consider any factors that may impact product disposition options such as the factors indicated in Table 1.

2. If disposition of the food is acceptable, consider the options that may be available, such as:
   • for use other than human consumption (for example, as waste, pet food or purposes other than for human food)
   • destruction to render the product unusable and un-salvageable (inedible)
   • order to remove the non-compliant imported product from Canada (SCFA 32)
   • exporting the product from Canada to a foreign market that will accept it
   • culling, processing, sorting or treating the product to correct a non-compliance
   • re-labelling to correct a non-compliance

3. Review the proposed disposition method to verify that the specific considerations described in Table 2 will be met, where applicable.

4. In addition to the specific considerations identified in step 3 (as applicable), the proposed disposition method must:

• resolve all non-compliance with applicable regulatory requirements
• not introduce a new non-compliance to SFCA, FDA or their regulations
• not pose a risk of contamination to existing food, animal feed systems and current and future food and water sources

Refer to Appendix A for a detailed list of questions to consider when assessing if a disposition method intended to correct the food for future sale in Canada or export can be authorized (for example, culling, re-label, re-package, treatment). Refer to Appendix B for a list of questions to consider when the disposition method will remove the food from human use in Canada (export of non-compliant food, order of removal, destruction and disposal).

If the food disposition method is appropriate and the proposal meets the general, legal and specific considerations identified above, the inspector may authorize the disposition and inform the regulated party of any conditions or CFIA oversight that may be needed during the disposition as described in section 6.2.

6.2 Monitoring the disposition

6.2.1 Authorizing the movement or alteration of a seized product

1. If the food has been seized, consult the Operational Procedure: Procedure for seizure and detention, authorizing movement and disposition for the steps to allow the movement or alteration of the seized food. For example, authorization is required to allow the seized product to be:
   • transported to a specified location for correction or disposition (for example, landfill or destruction site)
   • transported to borders or to other means of transport for removal from Canada (for example, trucking to airport or marine container ship)
   • culled, re-labeled, processed or treated to bring it back into compliance

6.2.2 Witnessing the disposition

1. If witnessing the disposition is required (for example products that are seized and detained, unlawful imports ordered removed or destroyed, recalls, or  non-compliance linked to a food safety issue or misrepresentation) verify that:
   • corrective measures are implemented as proposed
   • all known affected food available for disposition is corrected, destroyed, returned to origin or ordered removed from Canada
2. • If witnessing the disposition is not required, request documents, pictures, records or other materials to verify and document proper disposition. For example, request a copy of new labels, formulation calculations, proof that the food was ordered removed from Canada, bills of lading, insurance claim and certificates of destructions as appropriate.
   • Examples of acceptable proof that the food was ordered removed from Canada include:
     • a copy of the official bill of lading or airway bill of lading showing quantity, destination and carriers
     • document stamped by the customs foreign authorities
     • notification from foreign country to which the product was returned
     • Form E15 (Certificate of Destruction/Exportation) with section 13-20 (except 19) being completed by the Canada Border Services Agency

Refer to the Operational Procedure: Ordering removal, or destruction of unlawful food imports for specific guidance on witnessing disposal, as applicable.

6.3 Documenting the disposition

6.3.1 Collecting information to document the disposition

1. Collect a full description of the food being disposed, including:
   • the name of the food (company's internal product identification if applicable)
   • code identifiers including the specific lot code affected
   • package type and size
   • the quantity of food as noted in the Notice of Detention Form (CFIA/ACIA 3256), if applicable
   • inspection or Issues Management System (IMS) reference number
   • Harmonized System (HS) codes for imported food
2. Collect additional details relevant to the method of disposition by considering the information included in Table 3.

6.3.2 Recording the information in the relevant data capture system

Document the information concerning the disposition of the food based on the parameters in Table 4.

6.3.3 Additional guidance for documenting disposition of food identified during a food safety investigation or recall

When the food to be disposed was identified during a food safety investigation or recall, the following guidance should be applied when documenting the disposition in the IMS file:

• Issues Management System (IMS) User Manual (accessible only on the Government of Canada networks - RDIMS 1599661)
• Food incident response process

6.4 Closing the disposition case

If the regulated party has adequately implemented a suitable disposition method for the specific situation, close the inspection case.

If a suitable disposition was not adequately implemented, consult the Standard regulatory response process and the Operational guideline: Food regulatory response guidelines to determine available product control options. Refer to SIP section A.5.5.2 Capture regulatory response actions and Digital Service Delivery Platform Standard Operating Procedure Managing a Non-Compliance (accessible only on the Government of Canada networks – RDIMS 9906406) to document these regulatory response actions.

7. Appendices

• Appendix A – Questions to consider when assessing the suitability of a product disposition plan/method intended to correct product non-compliance for future sale as human food in Canada or export
• Appendix B – Questions to consider when assessing the suitability of a product disposition plan/method intended to remove the product from human consumption in Canada

For general inquiries related to this Operational Guidance Document, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF).

Appendix A: Considerations when assessing the suitability of a food disposition method intended to correct non-compliance for future sale as human food in Canada or export

• • Description of incident and food
  • What is the specific incident?
  • What is the food?
• • Disposition method, suitability and compliance
  • Is the corrective measure appropriate and sufficient to address the specific incident and bring the food into compliance?
  • Does the corrective measure take into account the microbiological sensitive nature of the food?
  • Is the regulated party able to show, with evidence, that the control measure to be applied is effective?
• • Prevention of other potential hazards
  • How is the non-compliant food identified and segregated from other foods?
  • Where is the food stored before and after correction?
  • Does the proposed corrective measure create further non-compliance?
• • Transportation of non-compliant food
  • What measures are taken to ensure that new potential hazards are not introduced while non-compliant food is being transported to another site for the application of the corrective measures? For example, time/temperature abuse, contamination from other sources.
  • What measures are taken to ensure that the non-compliant food does not re-enter the marketplace prior to correction?
• • Corrective action by regulated party or third party
  • Where will the corrective action take place? For example, facilities in the control of the regulated party, distributors, retail stores.
  • What instructions have been provided to ensure that the corrective action is properly performed by regulated party employees and third parties?
  • Who will implement the corrective action and when?
• • Demonstration of compliance and effectiveness
  • How will the regulated party ensure no new non-compliances are introduced?
  • How will the regulated party demonstrate that the non-compliant food both within and out of its control is now in compliance?

Appendix B: Considerations when assessing a disposition method intended to remove the food from human use in Canada (export of non-compliant food, destruction, disposal)

• • Description of incident and food
  • What is the specific incident?
  • What is the food?
• • Disposition method, suitability and compliance
  • Has the regulated party confirmed that the disposition method can be carried out in compliance with all applicable federal, provincial, municipal or foreign requirements (as the case may be) and that it will not pose a risk of contamination to existing food, animal feed systems and current and future food and water sources?
  • Where the affected food will be exported as a non-compliant food, has the regulated party provided documentation that the food meets the foreign country or the requirements of the person for whom the exported food is intended in accordance with SFCR 16(1)?
  • If the food is being destroyed, what methods are being used? Does the destruction prevent the potential reuse of the food by making the food inedible? For example, using denaturing agents, crushing of containers and food, exposing the food to chemicals such as bleach, acceptable landfill site, transported and disposed of by a recognized waste disposal or rendering company.
• • Prevention of other potential hazards
  • How is the food identified and segregated from other foods while awaiting disposition?
  • If the food will be disposed of in Canada for human use - other than for human food in accordance with SFCR 23(1)(c) (for example, cosmetics, therapeutic products, natural health products), has the regulated party confirmed that the product is acceptable for that use?
  • If the food will be disposed for use in animal food, has the regulated party demonstrated that the product will not pose a risk to the animal feed chain?
• • Transportation of affected food
  • If the affected food is transported to another site for disposition (other than for disposal as waste), what measures are taken to ensure that new potential hazards are not introduced (for example, time/temperature abuse of a microbiologically sensitive food, contamination from other sources)?
• • Corrective action by the regulated party or third party
  • Where corrective measures are implemented prior to the food being exported, does the regulated party meet the corrective measures guidance appropriate for the specific incident as stated in this document?
• • Demonstration of compliance and effectiveness
  • How will the regulated party demonstrate that the food meets specific requirements related to the disposition, such as information that shows it has been labelled according SFCR 16(1) or SFCR 23(1)(c) or that the food has been removed from Canada, as applicable.