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Fish Inspection Program Compliance Management Process

Table of Contents

1. Purpose

The purpose of this document is to describe the process applied by the Fish Inspection Program to generate compliance and respond to issues of non-compliance associated with the processing, importing and exporting of fish products.

2. Scope

This process applies to any individual or business entity that import, exports or attempts to import or export or process for export fish products in Canada.

3. Regulatory Authority

The following Acts and Regulations outlined below are relevant to the Fish Inspection Program Compliance Management Process:

This process document is consistent with the CFIA Compliance and Enforcement Operational Policy.

4. Fish Inspection Program Compliance Management Process

4.1 Fish Inspection Program Approach

To promote compliance, the CFIA may use a number of different tools to inform and educate regulated parties of their regulatory obligations. Examples of this type of information that may be provided to regulated parties include, but are not limited to: copies of legislation, fact sheets, pamphlets, educational activities, guidelines and regulatory directives.

Compliance is assessed through regular inspections conducted by designated CFIA staff. This includes activities such as: audits, verifications, monitoring, documentation review, sampling, complaint follow-up, analyses, grading and surveys, among other measures. An inspection determines whether there is compliance or non-compliance with the appropriate legislation. This finding is recorded, communicated to the regulated party and becomes part of the regulated party's compliance history.

Compliance with the Agency's legislation is mandatory. Once non-compliance is identified, the most appropriate compliance management measure to obtain compliance must be determined. In selecting the appropriate action, the following factors should be considered:

Harm
This takes into consideration the seriousness of harm or potential harm of the non-compliance; such as the potential impact on human health, as well as the potential for economic harm, or marketplace deception.

History
The compliance history of the regulated party will be considered with respect to the existence of previous instances and the seriousness of non-compliance.

Intent
The CFIA will consider the intent of the regulated party to commit an offence, such as evidence that the regulated party knowingly contravened the legislative requirements.

Where appropriate, the initial response to non-compliance may be corrective and remedial in nature, usually through corrective actions taken by the regulated party. When the regulated party is unwilling or incapable of correcting the non-compliance, CFIA has the necessary powers and authorities to address the non-compliance. Finally, remedial actions taken by the regulated party do not limit an inspector's ability to take stronger compliance management actions where the circumstances warrant this type of action.

The Fish Program Compliance Management Process document sets out the range of options available to enforce the legislative requirements applicable to the Fish Inspection Program. All regulated parties are required to comply with the FIA and its associated Regulations. This document provides a framework that promotes a fair, graduated and consistent approach when dealing with non-compliance.

4.2 Clear and Enforceable

The CFIA strives to ensure regulatory initiatives are both clear and enforceable. Clearly worded regulatory instruments promote compliance by making it easier for regulated parties to understand the requirements. Enforceable requirements likewise encourage compliance through the deterrent effect of possible compliance management action.

4.3 Information Letter

In order to provide regulatory guidance and clarification on new or existing initiatives, regulations, policy or legislation, regulated parties are provided with an information letter before they come into force.

These information letters can be distributed as part of the overall communications package and help ensure that the regulated parties receive and understand the necessary information regarding regulatory requirements. It should be noted that these information letters are in no way to be considered a formal enforcement action.

Note: While this action is called an "Information Letter" it is used in reference to any form of industry communication, including, but not limited to: letters, pamphlets, brochures, industry notices, guidelines, presentations and Listserv.

4.4 Inspection Reports

The intent of these reports is to officially inform the regulated party regarding their state of compliance as well as educate them to ensure they are aware of the potential compliance management activities for issues of non-compliance.

When an inspection report is completed and where corrective action is required, regulated parties are provided with reports that describe the issue of non-compliance, the compliance status of any inspected products and the potential for further enforcement activities should the non-compliance persist.

5. Compliance Management Actions

There are a broad range of compliance management activities available to the CFIA. In a consistent, graduated approach, one or more of the actions outlined in this section may be taken in response to non-compliance. The following section provides a detailed description of each compliance management activity available and the nature of each compliance management activity. This section also identifies situations where its use is generally appropriate.

On a day-to-day basis, inspectors designated to administer and enforce this legislation routinely take certain measures when responding to instances of non-compliance. As the severity of the non-compliance increases, further compliance management activities may be considered. In these instances, the inspector reports the non-compliance to his/her supervisor, where CFIA "decision makers" (including: Inspection Supervisors and Managers) consult on a case-by-case basis to determine the most appropriate response.

5.1 Letter of Non-compliance

A Letter of Non-compliance is a procedural administrative action that can be sent to a regulated party when non-compliance is detected for the first or second time. It may be appropriate in situations where:

  • the non-compliance has not resulted, or is not likely to result, in serious or very serious harm (such as health or safety risks, or marketplace deception);
  • the non-compliance is unintentional and easily corrected and the regulated party has demonstrated due diligence;
  • the regulated party has made reasonable efforts to remedy or mitigate the consequence of the non-compliance and compliance has been achieved; and
  • the inspector believes that a Letter of Non-Compliance will have the appropriate deterrent effect.

A Letter of Non-compliance should include the following information:

  • the date and location of the non-compliance;
  • the section(s) of the Act or Regulations that pertain to the non-compliance;
  • a summary of the facts and a short description of the non-compliance;
  • the time frame within which the regulated party is requested to respond to the letter of non-compliance, where applicable;
  • a statement that, if the non-compliance continues or there are repeat instances of non-compliance, enforcement action may be taken; and
  • the name and telephone number of the contact person to discuss the issue in greater detail.

The Letter of Non-compliance should be followed with an inspection after the date allowed for the regulated party to come into compliance, as specified in the Letter of Non-compliance.

5.2 Seizure and Detention

5.2.1 Detention for Identity Purposes

As set out in section 8 of the FIR, product detention for identity purposes is a procedural administrative action used as part of routine inspection activities to maintain the identity of, and control over, the product until it has been determined that the product meets legislative requirements. In the case of non-compliant product, product detention for identity purposes may be maintained until the product has been properly disposed, re-exported or otherwise brought into compliance.

5.2.2 Detention of Seized Product

Section 7 of the FIA permits seizure as a legal administrative action to gain or maintain control of a non-compliant product or thing. This action is generally appropriate where there are reasonable grounds to believe:

  • the non-compliance is likely to pose a risk to human health and safety; or
  • the non-compliance is likely to have an adverse impact on consumer protection; or
  • the person cannot or will not maintain the identity of the product; or
  • the person demonstrates an unwillingness to comply by failing to remove the product from the marketplace or by failing to take corrective action to bring the product into compliance.

Seized product, can be detained for:

  • up to 180 days; or
  • until the non-compliant product is brought into compliance; or
  • until proceedings have been finalized (if they have been initiated); or
  • until disposition is otherwise determined.

Seizure may be taken on its own or in conjunction with other compliance management activities.

5.3 Refusal of Entry of Product into Canada

Where a product that does not meet legislative requirements is detected at a point of entry, an inspector may inform the person in possession of the product that importation of the product contravenes the relevant Act or Regulations.

Refusal of entry of a product into Canada may be appropriate when:

  • the importer does not hold a valid import licence;
  • prior to importation, the product is known to pose a health and safety risk to humans; or
  • the product fails to meet the requirements set out in the FIA and/or FIR, or other applicable legislation.

5.4 Corrective Action for Non-compliant Imported Product

An inspector will require that an importer take corrective action to deal with a non-compliant product. The options available include destruction, re-exportation or, if possible, culling, re-working or re-conditioning.

This action may be appropriate when:

  • a person imports or attempts to import a product that fails to meet the requirements of the FIA and/or FIR.; or
  • the importer fails to submit notification of the imported shipment to an inspector within 48 hours of importation; or
  • in the case of high-risk products, the importer fails to provide a list indicating the establishment and the number of containers for each production code; or
  • in the case of canned or ready-to-eat fish, the importer fails to obtain and maintain process control documentation; or
  • at the time of importation the shipping cartons fail to accurately identify the foreign establishment where the fish was produced and the day month and year of processing.

The appropriate action will be determined based on the nature of the non-compliance.

5.5 Corrective Action for Non-compliant Product Processed in Canada

An inspector will require that a processor take corrective action to deal with a product that does not meet Canadian requirements. The options available include destruction or, if possible, culling, re-working or re-conditioning the regulated product. This action may be appropriate when a person exports or processes for export or attempts to export or process for export, a product that fails to meet the requirement of the FIA and/or FIR.

In some circumstances, exportation to a country where the product meets the foreign country requirements may be permitted in compliance with section 18 of the FIR and the fish permit policy.

The appropriate action will be determined based on the nature of the non-compliance.

5.6 Corrective Action for Product Imported without a Licence or Processed for Export in a Non-federally Registered Establishment

Product imported by a person who is not the holder of a fish import licence is considered to be a contravention of section 6.(2)(d) of the FIR and an inspector will require that the product be re-exported or destroyed.

Product processed for export in an establishment that is not registered with CFIA for processing fish constitutes a contravention of section 14(1) of the FIR and an inspector will require that the product be destroyed or otherwise disposed of within the province if permitted by provincial authorities. Some exceptions exist and processors are encouraged to verify their obligations prior to production.

5.7 Product Recall / Issuance of Recall Order

Recalling a product is appropriate when there are reasonable grounds to believe a regulated product poses a risk to public health and safety. In these cases the Minister may use a notice to the person selling, marketing or distributing the product notifying them that the product has been recalled and/or must be sent to a place designated by the Minister.

5.8 Refusal to Issue an Inspection Certificate

As set out in section 9 of the FIR, refusal to certify a product is appropriate when:

  • the product fails to meet legislative and/or regulatory requirements of the FIR; or
  • the product was not available for inspection.

5.9 Refusal to Issue a Foreign Country Export Certificate

Refusal to issue a foreign country export certificate is appropriate when:

  • the establishment did not comply with the FIR;
  • the product or establishment fails to meet any attestation included on the foreign country certificate;
  • the establishment is not eligible for export to the country; or
  • the product was not available for inspection.

5.10 Actions on Registrations and Licences

5.10.1 Refusal to Issue or Renew a Certificate of Registration, Fish Export Licence or Fish Import Licence

Pursuant to the Fish Inspection Regulations, the President of the CFIA may refuse to issue or renew a Certificate of Registration, Fish Export Licence or Fish Import Licence. This action is appropriate when there are reasonable grounds to believe that the applicant:

  • has provided false information for the purpose of obtaining a certificate of registration, export licence or import licence;
  • is unwilling or unable to comply with the Fish Inspection Regulations; or
  • has not paid any of the fees set out in the Canadian Food Inspection Agency Fees Notice that are payable under the Fish Inspection Regulations.

5.10.2 Suspension of a Certificate of Registration, Fish Export Licence or Fish Import Licence

Provisions in the FIR permit the President of the CFIA to suspend a Certificate of Registration, Fish Export Licence or Fish Import Licence. This action may be appropriate when:

  • the holder of the licence or the certificate of registration does not comply with the provisions of the Fish Inspection Act or Regulations;
  • in the case of a registered establishment, the establishment does not comply with the provisions of the Fish Inspection Act or Regulations;
  • it is reasonable to believe that public health will be endangered if the holder of the licence or certificate of registration is allowed to continue to operate;
  • the holder of a certificate of registration or the holder of the licence has not paid any of the fees set out in the Canadian Food Inspection Agency Fees Notice that are payable under the Fish Inspection Regulations; or
  • the holder of a licence or the certificate of registration has failed or is unable to take corrective measures within the required timeframe when non-compliance has been identified.

5.10.3 Reinstatement of a Suspended Certificate of Registration, Fish Export Licence or Fish Import Licence

A certificate of registration or licence that has been suspended may be re-instated if the holder of the certificate of registration or licence implements the required corrective actions within 60 days following the day on which the licence or certificate of registration was suspended. If it is not possible for the holder to implement the required corrective actions within 60 days, the CFIA may allow a longer period at the request of the holder of the licence or certificate of registration. The holder of the licence or certificate of registration must request in writing to the Regional Director that the licence be re-instated on the grounds that acceptable corrective actions have been implemented or by appealing the original decision to suspend the licence or registration (see section 6.2 for Appeal).

Where an inspection is required to verify that corrective measures were appropriate to comply with the Fish Inspection Regulations prior to re-instatement of a suspended licence or certificate of registration, the holder of the licence or certificate of registration must pay the appropriate fee set out in the Canadian Food Inspection Agency Fees Notice.

5.10.4 Revocation of a Certificate of Registration, Fish Export Licence or Fish Import Licence

Provisions in the FIR allow the President of the CFIA to revoke a Certificate of Registration, Fish Export Licence or Fish Import Licence. This action may be appropriate when:

  • the certificate of registration, fish export licence or fish import licence has been suspended and the holder of the certificate of registration or licence is unable or unwilling to implement the required corrective actions and bring themselves into compliance within 60 days following the suspension or within a longer period as agreed to by CFIA;
  • an inspector is unsuccessful in attempts to contact the holder of a export licence or certificate of registration, using all reasonable means, within a period of 90 days; or
  • there are reasonable grounds to believe that the application for the licence or a certificate or registration contains false or misleading information.

5.10.5 Reinstatement of a Revoked Certificate of Registration, Fish Export Licence or Fish Import Licence

A certificate of registration or licence that has been revoked may be re-instated if the holder of the certificate of registration or licence implements the required corrective actions within 60 days following the day on which the licence or certificate of registration was revoked.

The holder of the licence or certificate of registration must request in writing to the Regional Director that the licence or certificate of registration be re-instated on the grounds that acceptable corrective actions have been implemented or by appealing the original decision to revoke the licence or registration (see section 6.2 for Appeal).

Where an inspection is required to verify that corrective measures were appropriate to comply with the Fish Inspection Regulations prior to re-instatement of a revoked licence or certificate of registration, the holder of the licence or certificate of registration must pay the appropriate fee set out in the Canadian Food Inspection Agency Fees Notice.

The decision rendered by the Regional Director is final and no further appeal is permitted. The person may apply for a new licence or certificate of registration at a later date.

5.11 Prosecution

The Public Prosecution Service of Canada (PPSC) has the responsibility for all prosecutions relating to the Acts administered by the CFIA. Where prosecution is deemed appropriate by the CFIA, enforcement officials will forward briefs of evidence to the appropriate office of the PPSC with the recommendation that charges be laid. It is clearly recognized by this strategy that the discretion to initiate a prosecution rests with the PPSC.

The CFIA recommends prosecution to PPSC where non-compliance with the FIA or FIR results in or involves:

  • death of, or injury to, a person and the evidence indicates that the death or injury was directly attributed to failure to comply with the above mentioned legislation;
  • the wilful, reckless, or negligent actions of the regulated party that pose a health and safety risk to humans or misleads the consumer, misrepresents the product or constitute marketplace deception;
  • the prohibited sale of a product;
  • the forging of, altering or tampering with an inspection certificate, permits, report of analysis or other official CFIA document;
  • the obstruction of interference with an inspector acting in the execution of the above mentioned Act and Regulations;
  • the movement or interference with any thing seized and detained without having received prior permission from an inspector;
  • refusal to comply with a recall order;
  • a conviction for a previous similar offence; or
  • based on past history of non-compliance, other enforcement actions that have not had, and are not likely to have, the appropriate deterrent effect and more severe action is warranted.

6. Other Actions

6.1 Meeting with Regulated Party

A Meeting with a Regulated Party is a procedural administrative compliance management activity that provides the regulated party with an opportunity to meet face-to-face with the CFIA to discuss issues of non-compliance.

A Meeting with a Regulated Party may be appropriate when a regulated party has resisted taking voluntary corrective actions with respect to non-compliance or if previous compliance measures have not been effective. This meeting should occur prior to initiating more serious action (e.g., licence/registration suspension, revocation, or prosecution). A meeting may also be appropriate before lost privileges (such as suspended/revoked registration or licence) are reinstated.

This measure is purely administrative and the CFIA has no legislative or regulatory authority to impose such a meeting on the regulated party; however, it does provide the regulated party with an opportunity to come into compliance.

6.2 Regulated Party's Right to Appeal an Inspection Decision and Re-inspection

In accordance with section 10(1) of the FIR, any person may appeal an inspector's decision relating to an inspection, systems verification, compliance verification, grading or marking. An appeal must be made in writing to the President of the CFIA, stating the reason(s) why a decision should be given further consideration. The appeal must be received within 30 days of receiving the inspector's initial decision. Pending the outcome of an appeal or a reinspection, the original decision will remain valid.

Where a reinspection is ordered by the Regional Director, the results of the reinspection will be final.

Appendix A: Summary of Compliance Management Activitites for the Fish and Seafood Program

Compliance Management Actions: FIA/FIR Section Act/Reg
Information Letter Procedural Administrative Action --
Letter of Non-Compliance Procedural Administrative Action --
Detention for Identity Purposes 8 FIR
Detention of Seized Product 7(1),(2) FIA
Refusal of Entry of Product into Canada 6(1), 6(2) FIR
Corrective Action for Non-compliant Imported Product 6(1), 6(2), 6.1(3)(c)(d) FIR
Corrective Action for Non-compliant Product Processed in Canada 6(1) FIR
Corrective Action for Product Imported without a Licence 6.(2)(d) FIR
Corrective Action for Product Processed for Export in a Non-federally Registered Establishment 14(1) FIR
Product Recall/ Issuance of Recall Order 19(1) CFIA
Refusal to Certify Product 9(1), 9(2) FIR
Suspension or Revocation of a Certificate of Registration or Fish Export Licence 17(1) FIR
Refusal to Issue or Renew a Certificate of Registration or Fish Export Licence 17(1) FIR
Suspension or Revocation of a Fish Import Licence 6.2(1) FIR
Refusal to Issue a Fish Import Licence 6.2(1) FIR
Request for Reinstatement of a Certificate of Registration or Licence 6.2(2), 17(2) FIR
Meeting with Regulated Party Procedural Administrative Action --
Right to Appeal an Inspection Decision and Re-inspection 10(1) FIR
Prosecution 17.1 FIA

Appendix B: List Of Acronyms

CFIA: Canadian Food Inspection Agency
CPLA: Consumer Packaging and Labelling Act
FDA: Food and Drugs Act
FIA: Fish Inspection Act
FIR: Fish Inspection Regulations
PPSC: Public Prosecution Service of Canada

Appendix C: List of Definitions

Compliance:
The state of conformity of regulated parties with the law.

Compliance Management:
Managing compliance using the wide range of tools available to the CFIA across the enforcement continuum. This includes promoting compliance and assessing and responding to non-compliance as it relates to CFIA's activities.

Decision Makers:
For the purpose of this strategy, this includes CFIA Inspection Supervisors, Inspection Managers, Regional Directors, Executive Directors and Program Specialists.

Detention for Identification:
An action used as part of routine inspection activities to maintain the identity of, and control over, a product until a decision is rendered on its state of compliance and disposition is determined.

Seizure of Product:
An action to gain/maintain control of a product or thing.

Enforcement:
The use of administrative tools as well as inspection powers granted under legislation to determine and compel compliance with the applicable laws.

Inspection:
Activities including: audits, verifications, monitoring, analyses, grading and surveys; undertaken by inspectors to verify compliance with the CFIA's legislation.

Investigation:
An investigation involves the gathering of evidence and information, from a variety of sources, relevant to a suspected offence.

Legal Administrative Action:
An administrative action found in the Act and Regulations (e.g., suspension of an operator's licence).

Letter of Non-Compliance:
A procedural administrative action that may be used to promote voluntary corrective action and may be sent to a regulated party when an offence is detected for the first or second time, depending on the gravity of the non-compliance of the regulated party.

Meeting with Regulated Party:
A procedural administrative action that provides the regulated party with an opportunity to meet face-to-face with the CFIA to discuss issues of non-compliance.

Offence:
A violation of the law.

Procedural Administrative Action:
An administrative action that is procedural in nature and created by CFIA policies (i.e., letter of non-compliance).

Regulated Party:
An individual or business entity undertaking activities that are regulated by CFIA legislation, or activities that fall under the purview of the CFIA.

Document Type: Regulatory Process / Status: Version 1
Date: April 15, 2011 / Review Date: April, 2012

Date Modified: 2011-04-21

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