Operational Procedure: Procedures for suspending and lifting the suspension of a Safe food for Canadians licence

1. Purpose

The purpose of this document is to provide guidance to the Canadian Food Inspection Agency (CFIA) inspectorate on the procedures respecting suspending and lifting the suspension of a licence issued under subsection 20(1) of the Safe Food for Canadian Act (SFCA) and its regulations.

This document is intended to be used in conjunction with other CFIA guidance documents as referenced in section 3.0 including the Standard regulatory response process (SRRP) and the Operational guideline – Food regulatory response guideline.

Although this guidance document speaks solely to suspending and lifting the suspension of an SFC licence, the CFIA has the necessary powers and authorities to address non–compliance through the use of a variety of control and enforcement actions. These actions can be used independently or concurrently as the situation warrants.

2. Authorities

Safe Food for Canadians Act (SFCA), Section 22
Safe Food for Canadians Regulations (SFCR), Sections 35 to 38

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

3. Reference documents

4. Definitions

Definitions are located in either the:

5. Acronyms

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

6. Operational procedure

6.1 Confirm that the licence holder has been provided a written report of the grounds for suspension

Verify that the licence holder has been provided with a written report of the grounds for suspension as per SFCR 36.

A written report must include the grounds for the suspension and the period within which corrective action must be taken in order to avoid the suspension and should be in the forms described in table 1, as applicable.

Table 1: Grounds for suspension and type of written report
Grounds for suspension (regulatory reference)	Written report
SFCR 35 The Minister may suspend a licence if (a) the licence holder does not comply with any provision of the act, other than section 15^{Table Note 1}, or with any provision of these regulations, the Food and Drugs Act or the Food and Drug Regulations Considering: SFCR 36(1) The Minister must not suspend a licence unless the licence holder (a) was provided with a written report that sets out the grounds for the suspension and the period within which corrective action must be taken in order to avoid the suspension; and (b) failed to take corrective action within that period.	A standard inspection procedures (SIP) inspection report Or A letter of non-compliance (LoNC)(if applicable) which identifies the (1) Legal name of regulated party and (2) Permission numbers at risk of suspension. The LoNC must include the sentence "To avoid suspension of your licence, corrective action(s) for the identified non-compliance(s) must be taken within the period identified"
SFCR 35 The Minister may suspend a licence if (b) the licence holder is in default of payment of any fee related to the licence that is fixed under the Canadian Food Inspection Agency Act Considering: SFCR 36(1) The Minister must not suspend a licence unless the licence holder (a) was provided with a written report that sets out the grounds for the suspension and the period within which corrective action must be taken in order to avoid the suspension; and (b) failed to take corrective action within that period.	A letter issued by CFIA's Account Receivable identifying the fixed fee(s) related to the licence in default Note: this process is administered by CFIA Accounts Receivable. This operational procedure (OP) does not address this process.
SFCR 35 The Minister may suspend a licence (c) the Minister is of the opinion that a risk of injury to human health may result if the licence holder continues to conduct an activity that is identified in the licence Considering: SFCR 37(1) Despite section 36, if the Minister is of the opinion that a risk of injury to human health may result if the licence holder continues to conduct an activity that is identified in the licence, the Minister may suspend the licence immediately after the licence holder is provided with a written report that sets out the grounds for the suspension	Note: the Minister or their delegated authority may suspend a licence immediately (SFCR 35(c)) if they are of the opinion there is a risk of injury to human health and the licence holder has been provide a written report identifying the risk (SFCR 37(1)). SFCR 35(c) is not dependent on a non-compliance. If there is an associated non-compliance: A SIP inspection report When there is an associated non-compliance, the SIP inspection report must identify both the non-compliance and the risk of injury to human health that sets the ground for immediate suspension. Do not indicate a due date for corrective action in the inspection report if the Minister's delegate has decided to suspend immediately on the grounds of risk of injury to human health. In the event there is no associated non-compliance, a written report outlining the grounds (risk of injury to human health) must be provided and may be in the form of a letter (separate from the Notification of Suspension of an SFC Licence).

Note: as reflected in the Chart Summarizing Delegation of Ministerial Authorities (accessible only on the Government of Canada network – RDIMS 9366193), the duties and functions of the Minister as they relate to the suspension under SFCR 35 and lifting the suspension under SFCR 38 of a Safe Food for Canadians (SFC) licence have been delegated to the Director of Operations of Operations Branch and the Director of Operations (DO) responsible for the National Centre for Permissions.

If the SIP inspection report for the initial inspection, does not include the statement that sets out the grounds for the suspension then the Minister's delegate must not suspend the licence. Consult the SRRP and the Food Regulatory Response Guidelines to determine if alternative regulatory responses should be considered.

When a suspension for a non-compliance is recommended after a follow-up inspection has determined that the licence holder failed to implement corrective actions, the inspection report that was issued during the initial inspection serves as the written report of non-compliance required in order for the Minister's delegate to be able to suspend the licence. Consequently, the written report issued following the initial inspection must have clearly identified the nature of the non-compliance, the date by which corrective actions must have been implemented, and a statement that failure to implement corrective actions within the specified timeframe may result in suspension of the licence. When recommending suspension after a follow-up inspection has determined the licence holder failed to implement corrective actions within the specified timeframe, ensure there is no due date for corrective action on the follow up SIP inspection report.

When a suspension due to risk of injury to human health is recommended immediately after inspection, control actions to mitigate any risk associated with implicated products should be taken simultaneously (for example, product seizure and detention). A written report without a corrective action due date must also be provided to the licence holder since the Minister's delegate may only suspend the licence "immediately after the licence holder is provided with a written report that sets out the grounds for the suspension".

6.2 Verify that grounds for suspension are met

Before recommending to the Minister's delegate that they suspend a licence, verify that at least 1 of the grounds for suspension identified in SFCR 35 has been met. Refer to the Operational guideline – Food regulatory response guidelines to verify that grounds for suspension of a licence are met.

6.3 Evaluate if suspension is an appropriate regulatory response to the non-compliance

Review all relevant facts and consider all available regulatory response options prior to recommending a suspension. Evaluate if a suspension may be an appropriate response to the non-compliance by referring to the Standard regulatory response process (SRRP) to review available responses to non-compliance to regulatory requirements.

6.4 Prepare a recommendation for suspension of a licence

The recommendation and supporting documentation should provide the information about the specific case that must be assessed by the Minister's delegate when deciding on whether or not to proceed with a licence suspension action. Table 2 below provides the operational division of duties when preparing a recommendation for suspension.

Table 2: Operational division of the roles of preparing a recommendation for the suspension of a licence
Responsible position	Roles	Description
Inspection staff	1. Complete a Recommendation for an SFC Licence Action Form (Action Form) 2. Submit the Action Form and supporting documentation (recommendation package) to supervisor	Include all information as set out on the Action Form. In particular: sections of the SFCA, SFCR and or Food and Drugs Act (FDA), Food and Drug Regulations (FDR) that are not complied with the compliance and licence history of the licence holder (as per SRRP) attach supporting documentation such as previous letters of non compliance information on the real or potential harm that has or may arise from the non-compliance(s) that led to the recommendation (as per SRRP) information that indicates intent on the part of the licence holder information concerning the events that led to the inspection by CFIA and inspection findings and facts that support the recommendations made attach any supporting documentation, such as inspection reports recommendation for the suspension of the licence rationale for recommending suspension and any alternative or complementary responses that could be considered along with or in the place of a decision to suspend (such as administrative monetary penalties (AMPs), Enforcement and Investigation Services investigation, meeting with the regulated party)
Supervisor	3. Review the recommendation package for completion, verify that the grounds for suspension have been met 4. Sign Action Form and submit to the Inspection Manager (IM)	Ensure the recommendation is consistent with the Operational guideline – Food regulatory response guidelines
Inspection Manager (IM)	5. Review the recommendation package. 6. Sign Action Form and submit recommendation package to the Director of Operations (DO) to whom they report

At any point during the process, the Supervisor or IM may follow established communication pathways to consult with subject matter experts including the Area's Operational Specialist Unit, Operational Guidance and Expertise (OGE) Division or Legal Services.

6.5 Responsibilities of the Minister's delegate

When a recommendation package is received by a DO, that DO must consult the Supplemental guidance for Safe Food for Canadians licence action decision makers to determine the most appropriate Minister's delegate to perform the tasks identified below. The "Supplemental guidance for Safe Food for Canadians licence action decision makers" also provides guidance to the Minister's delegate when deciding whether to suspend or lift the suspension of a licence and the tasks to be performed to carry out that decision.

In addition to the "Supplemental guidance for Safe Food for Canadians licence action decision makers", the Minister's delegate who will make the decision reviews the information included in the recommendation package and considers :

the factors of harm, history and intent
any other information at their disposal that is relevant to the case at hand
any relevant policies such as the Compliance and Enforcement Policy, Standard regulatory response process and the Operational guideline – Food regulatory response guidelines

The Minister's delegate documents and informs inspection staff of the decision by completing the designated fields on the Action Form and returning it to the IM.

Note: the positions delegated the authorities of the Minister as they relate to the suspension and lifting the suspension of an SFC licence are found in the Chart summarizing delegation of Ministerial authorities (accessible only on the Government of Canada network – RDIMS 9366193)

6.6 Implementation of the Minister's delegates decision

Upon receiving the completed and signed Action Form, proceed as per Table 3.

Table 3: Actions to be taken by the inspection staff
If	Then
The Minister's delegate decided to suspend the licence	Proceed to Section 6.7
The Minister's delegate decided not to suspend the licence	Stop this procedure Consult the SRRP to determine if alternative responses should be considered

6.7 Draft a suspension letter

If the decision to suspend the licence has been made by the Minister's delegate, use the templates in Appendix 1 to draft the appropriate suspension letter.

Use the "Notification of Suspension of an SFC Licence" template for situations where a licence will be suspended on the grounds set out under paragraph 35(a) of the SFCR
Use the "Notification of Suspension of an SFC Licence Due to Risk of Injury to Human Health" template for situations where a licence will be suspended on the grounds set out under paragraph 35(c) of the SFCR

Provide the draft letter to the Minister's delegate using the established communication pathway for review, revision, as needed, and signature.

Note: the Minister's delegate is responsible for reviewing, editing, as required, and signing the notifications. Only the Minister or a person occupying a position to whom the Minister has delegated the duties and functions of the Minister to suspend a licence under section 35 of the SFCR may make the decision to suspend a licence.

6.8 Notify the licence holder of the CFIA decision to suspend their licence

Upon receiving the signed notification from the Minister's delegate, inspection staff will:

send the original Notification of Suspension wet signed by the Minister's delegate who made the decision to the licence holder by registered mail, or hand deliver in person (if digitally signed, send the letter by email)
follow up with the licence holder by telephone or in person, if it was delivered by registered mail or email, to ensure they received the notice and understand it
maintain a copy of the signed suspension letter and Action Form in file
for inspections documented in DSDP:
1. a) enter the details of the licence suspension in the DSDP by referring to SIP section A.5.5.2 Capture regulatory response actions and DSDP SOP Managing a Non-Compliance Record (accessible only on the Government of Canada network – RDIMS 9906406)
2. b) in the Non-compliance Response Details tab add a new Regulatory Response and select the Regulatory Response Type: Action against a permission – suspend
3. c) since, at this step in the process, the licence action details are being entered after the decision to suspend the licence has been made, select the Response Status: Issued
4. d) at a minimum, add copies of the Action Form, and the "Notification of Suspension of an SFC Licence" letter to the Documents sub-grid within the new regulatory response record

Note: if the licence holder continues to conduct an activity that is identified in their licence while the licence is suspended, refer to the Standard regulatory response process and the Food regulatory response guidelines to determine appropriate enforcement and or control measures.

6.9 Confirm the licence holder's status on registries and lists maintained by National Centre for Permissions

The Minister's delegate is responsible to ensure the National Centre for Permissions (NCP) is notified of the decision to suspend an SFC licence. As per Section 6.10 of the Supplemental guidance for SFC licence action decision makers, the Minister's delegate will include the inspection staff responsible for verifying compliance of the licence holder on the email to the NCP.

The NCP will update the applicable registries based on the date and time the licence action takes effect. After the licence action has taken effect, inspection staff will need to confirm that the licence holder's status has been updated on the:

Safe Food for Canadians Licence Registry
Export registries (as applicable) – the Canadian fish and seafood establishments approved for export, the Search the list of Federally Registered Meat Establishments and their Licensed Operators, the list of Processed egg stations registered for export and the list of Shell egg stations registered for export

It should be noted that after the NCP amends the status of the licence on the Safe Food for Canadians Licence Registry it may take up to 4 hours for the change to take effect.

6.10 Follow up on an SFC licence suspension

Suspension of a licence remains in effect until the Minister's delegate determines that corrective actions have been taken. To help inform the Minister's delegate, assess the licence holder's response to the suspension of the licence based on the guidance in Table 4, below.

Table 4: Determining next steps following licence suspension
If	Then
the licence holder has notified the CFIA within 90 calendar days following suspension (or longer, if agreed upon) that corrective actions have been taken to correct the non-compliance that led to suspension	conduct an inspection to verify that corrective actions have been taken to bring the licence holder into compliance verify that inspection fees are paid (Note: this OP does not address this process as it is administered by Accounts Receivable) if the required corrective actions have been taken, complete a Recommendation for an SFC Licence Action form to recommend lifting the suspension of the licence and submit it to your supervisor. Proceed to Section 6.11
the licence holder failed to implement effective corrective actions within 90 calendar days (or longer if granted by the Minister's delegate) following the suspension to correct the non-compliance that led to suspension	stop this procedure refer to the Operational procedure – Procedures for cancelling a Safe Food for Canadians licence

6.11 Lifting an SFC licence suspension

The Supervisor reviews the Action Form and verifies that conditions for lifting the suspension have been met and submits for IM review. IM reviews the recommendation and submits the Action Form for decision by the Minister's delegate.

At any point during the process, the Supervisor, IM may consult with relevant subject matter experts such as the Area's Operational Specialist Unit, OGE Division or Legal Services to confirm that the conditions lifting the suspension have been met.

Note: as with the decision to suspend, only a person delegated the duties and functions of the Minister under SFCR 38 may make the decision to lift the suspension of a licence. This would typically be the same person that decided to suspend the licence.

6.12 Implementation of the Minister's delegate's decision to lift a suspension

If the Minister's delegate decides that the licence suspension should be lifted, they indicate this decision by completing the designated fields, signing and returning the Action Form to the IM. The IM provides the completed Action Form to the responsible inspection staff to:

draft a "Notification that suspension of an SFC licence is lifted" using the template in Appendix 1
provide the draft "Notification that suspension of an SFC licence is lifted" to the Minister's delegate for review, revision, as needed, and signature, using the established communication pathways
mail or email the notification letter signed by the Minister's delegate to the licence holder
follow up with the licence holder by telephone or in person, if the notification has been mailed or emailed, to ensure they have received the notification and understood it
maintain a copy of the signed letter and Action Form in the file
verify that the status of the licence holder on the Safe Food for Canadians Licence Registry and other applicable eligibility lists has been updated (based on the date and time the suspension will be lifted, as per Section 6.9)
record the result of the follow up inspection and document that the licence suspension has been lifted in the Notes section of the follow up case in the DSDP

7. Appendix

Appendix 1 – Forms and templates

For general inquiries related to this Operational Guidance Document, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF) (accessible only on the Government of Canada network).

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