Food > Fish and Seafood > Product Inspection > Facilities Inspection Manual CHAPTER 7 To download in Adobe PDF 1. SCOPE The Compliance and Enforcement Strategy provides a framework that outlines the principles and actions that will be followed by the Canadian Food Inspection Agency (CFIA) with the goal that regulated parties operate in full compliance with the Fish Inspection Act (FIA), Fish Inspection Regulations (FIR) and other applicable legislation. This program specific strategy is consistent with CFIA's Enforcement and Compliance Policy (Revised September 1999) developed and maintained by the Enforcement and Investigation Services (EIS) Division. The CFIA Enforcement and Compliance Policy provides the overarching policy for enforcement and compliance activities across all commodity programs. In addition to the Compliance and Enforcement Strategy being contained within both the Fish Products Inspection Manual and the Facilities Inspection Manual, it will also be issued as an appendix to the CFIA Enforcement and Compliance Policy. Compliance is normally achieved through a co-operative approach between the regulated party and CFIA in correcting non-conformities through the development of appropriate Corrective Action Plans or other methods. However, when this co-operative approach has ceased, or when the regulated party is incapable of correcting non-conformities, the Compliance and Enforcement Strategy provides CFIA staff with enforcement options that are to be used in responding to infractions of the FIA, FIR and other applicable legislation. This document also defines discretionary parameters for inspectors and establishes principles for fair and consistent enforcement. 2. AUTHORITIES Fish Inspection Act (FIA), R.S., c. F-12 Food and Drugs Act, R.S., c. F-27 Consumer Packaging and Labelling Act, R.S., c. 38 3. POLICY 3.1 Responsibility for Enforcement Actions Area Executive Directors are accountable for compliance and enforcement actions undertaken within their respective areas. Regional Directors are responsible for the approval of compliance and enforcement actions including refusal, suspension and revocation of certificates of registration, licenses and permits. They are also responsible for the approval of all recommendations to prosecute. The Regional Director must be consulted and informed when significant enforcement actions are being considered. 3.2 General Enforcement and Compliance Principles In applying the Fish Inspection Program, the CFIA will promote compliance with the FIA, FIR and other legislation through consultation, education and enforcement. These activities are based on the following guiding principles:
3.3 Measures to Promote and Monitor Compliance 3.3.1 Consultation and Education As consultation and education initiatives promote understanding of legislative and regulatory requirements and thereby generally facilitate compliance, CFIA will strive to:
3.3.2 CFIA Regulatory Verifications Inspectors will conduct regulatory verification activities to assess industry's compliance with the FIA, FIR and other applicable legislation, in accordance with established policies and procedures. These activities include:
3.4 Responses to Violations and Non-compliance When CFIA inspectors have reasonable grounds to believe that an infraction has been committed under the FIA, FIR, or other applicable legislation, they will conduct investigations to determine the facts of the alleged infraction(s) and to gather and preserve evidence. Once it has been determined that an offence has occurred, the inspector may seek advice, guidance and assistance from the Enforcement and Investigation Services (EIS) Division as necessary. The assistance of an investigation specialist should be used particularly in instances involving circumstances of a complex nature that require specialised investigational expertise. For further information, refer to Part 7.0 of the CFIA Enforcement and Compliance Policy developed by the EIS Division. Instances of non-compliance will be evaluated and the most appropriate action to achieve compliance will be determined. The following factors, along with other applicable information, will be considered:
3.5 Enforcement Actions One or more of the enforcement actions outlined in this section will be taken to achieve compliance for violations of the FIA, FIR or other applicable legislation. 1. Actions with respect to individuals and companies:
2. Actions with respect to products, equipment or other things:
3. Other Actions:
3.5.1 Warning A written warning is appropriate when the non-compliance has not resulted, or is not likely to result, in significant or serious harm and the inspector believes that the letter will have the appropriate deterrent effect. Significant or serious harm would include health or safety risks, or fraud. A written warning must contain the following information:
A warning letter is not required in the case of QMP or QMPi compliance verifications that have shown non-conformities provided that the regulated party has been given a Non-Conformity Report during the exit meeting (refer to Chapter 3, Subject 3 of the Facilities Manual for QMP; Chapter 3, Subject 4 of the Inspection Manual for QMPi). However, a written warning should still be considered if the regulated party fails to develop an acceptable Corrective Action Plan or fails to meet the terms of a Corrective Action Plan. 3.5.2 Prosecution For violations of the FIA, FIR or other applicable legislation, a prosecution is appropriate when the offence involves:
3.5.3 Product Detention Detention of a product is appropriate when the identity of the product must be maintained until analysis is complete, until non-complying product is brought into compliance, or until disposition is otherwise determined. Product detention is not necessarily an enforcement action. Detentions can be part of routine inspection activities such as for maintaining the identity of the product pending the results of laboratory analysis. Further information on product detention may be found in the Inspection Manual, Chapter 2, Subject 3. NOTE: Where non-compliant product is identified during a compliance verification and the registered establishment or QMPi licence holder can demonstrate, to the satisfaction of the inspector, that the problem with the product will be resolved as part of a Corrective Action Plan, product detention is not necessary. 3.5.4 Product Seizure Seizure of product is generally appropriate when:
Further information on product seizure may be found in the Inspection Manual, Chapter 2, Subject 4. NOTE: Where non-compliant product is identified during a compliance verification and the registered establishment or QMPi licence holder can demonstrate, to the satisfaction of the inspector, that the problem with the product will be resolved as part of a Corrective Action Plan, product seizure is not necessary. 3.5.5 Refusal of Entry of Product into Canada Refusal of product entry into Canada may be appropriate when the product is identified prior to importation to pose a health or safety risk to humans or otherwise fails to meet the requirements of the FIA, FIR or other applicable legislation. 3.5.6 Removal of Imported Product Fish products that do not comply with the FIA, FIR or other applicable legislation must be re-exported back to the country of origin or disposed of. This applies only to product which the regulated party cannot or will not bring into compliance. Further information on removal of imported product may be found in the Inspection Manual. 3.5.7 Issuance of Recall Orders A recall by any regulated party selling, marketing or distributing a product is appropriate when that product poses a risk to public health and safety. The CFIA will work with regulated parties to ensure that an effective recall takes place. In the event that an individual or company refuses to voluntarily recall a product, a recall may be ordered pursuant to section 19 of the CFIA Act. Please refer to the CFIA's recall policy and procedures, maintained by the Office of Food Safety and Recall, for further information. 3.5.8 Refusal to Certify Product Refusal to certify a product is appropriate when the product fails to meet all pertinent legislative and regulatory requirements, or additional requirements specified by the importing country. 3.5.9 Suspension or Revocation of an Establishment's Certificate of Registration Suspension or revocation of an establishment's certificate of registration, pursuant to subsection 17(1) of the FIR, is appropriate when:
Other reasons for suspending or revoking a certificate of registration are outlined in subsection 17(1) of the FIR including when false information is provided by the establishment in order to obtain a certificate of registration. A certificate of registration which has been suspended or revoked will not be reinstated until all deficiencies that resulted in the suspension or revocation have been corrected. To reinstate a certificate of registration which has been suspended or revoked, see the policies and procedures in Chapter 2 of the Facilities Manual. 3.5.10 Suspension or Revocation of a Fish Import or QMPi Licence Suspension or revocation of an import licence pursuant to subsection 6.2(1) of the FIR is appropriate when:
Other reasons for suspending or revoking an import licence are outlined in subsection 6.2(1) of the FIR including where the importer fails to adequately maintain records in accordance with the FIR and where the importer has provided false information in order to obtain a licence. Where QMPi privileges have been suspended or revoked, they will not be reinstated until all deficiencies have been corrected including any necessary amendments to the importer's record keeping, documentation, or operational procedures. The importer has the option to apply for a fish import licence if they no longer wish to operate under the provisions of the QMPi licence. Further information on applying for a fish import licence may be found in the Inspection Manual, Chapter 3, Subject 1. 3.6 Formal Hearing A Formal Hearing involves meeting with the regulated party to discuss issues of non-compliance, and may result in the development of a Corrective Action Plan by the regulated party, if there has been no Corrective Action Plan previously. Such a hearing may be appropriate when previous enforcement options (e.g., Warning letter) have not been effective, but prior to initiating more serious enforcement options (e.g., Licence revocation, prosecution). A hearing may also be appropriate before lost privileges are reinstated. If a formal hearing will be held, the Regional Director (or delegate) will initiate and convene such hearings. 3.7 Removal from Public Lists The CFIA may remove the name of any regulated party, whose certificate of registration or import licence has been suspended or revoked, from any public list of registered establishments or import licence holders. 3.8 Appeals and Reinspections In accordance with section 10 of the FIR, any person may appeal an inspector's decision relating to an inspection, systems verification or compliance verification, grading or marking. An appeal must be made in writing to the Regional Director, stating the reason(s) why a decision should be given further consideration. The appeal must be received within 30 days of the decision that is being appealed. 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 decision of the reinspection will be final. Chapter 2, Subject 2 of the Inspection Manual outlines the policy and procedures governing the reinspection of fish and fish products pursuant to section 10 of the FIR. Chapter 3, Subject 3 of the Facilities Manual outlines the appeal process for compliance verification decisions. 4. COMPLIANCE AND ENFORCEMENT PROCEDURES - QMP 4.1 Assessing a QMP as Unacceptable A registered establishment's Quality Management Program will be assessed as unacceptable when a compliance verification has identified non-conformities and:
NOTE: When a critical non-conformity is identified, the registered establishment must be required to immediately develop a Corrective Action Plan and implement corrective actions to bring the system back under control. A thorough investigation across the entire QMP plan may be conducted. Detention and seizure actions must be considered. It may be necessary to suspend and re-schedule the compliance verification if the critical non-conformity is not satisfactorily addressed. When product with a potential consumer health and safety risk has entered commercial channels, the appropriate area/regional recall coordinator must be consulted regarding possible recall action for the implicated product. Further information on the identification of critical non-conformities may be obtained in Chapter 3, Subject 3 of the Facilities Manual. 4.2 Measures to be Taken for an Unacceptable QMP 4.2.1 The registered establishment has failed to develop an acceptable Corrective Action Plan Where the establishment is unwilling or unable to develop an acceptable Corrective Action Plan, the following measures will be taken:
4.2.2 The registered establishment has failed to meet the terms of a Corrective Action Plan and reach closure of the compliance verification Where the establishment has failed to meet the terms of a Corrective Action Plan, the following measures will be taken: a) when the establishment can demonstrate that actions have been taken and the terms of the Corrective Action Plan have not been reached through circumstances beyond the establishment's control or time deadlines that have not proven realistic, then the establishment may continue operating with new time frames for completion of the Corrective Action Plan, if the non-conformities are not likely to result in product which fails to meet all requirements of the FIR and other applicable legislation. A warning letter may accompany this option stating that failure to meet new time deadlines will result in a recommendation that the establishment's certificate of registration be suspended. b) when the terms of the Corrective Action Plan have not been reached through negligence, deliberate inaction by the establishment or inability of the establishment, the same steps will be taken to suspend the certificate of registration as outlined in section 4.2.1. 4.2.3 The registered establishment has a history of operating without proper controls and is unlikely to initiate an effective Corrective Action Plan Where the establishment has a history of non-compliance and operating without the proper controls, the same steps will be taken to suspend the certificate of registration as outlined in section 4.2.1. 4.3 Request for Reinstatement of a Certificate of Registration Subsection 17(2) of the FIR sets out regulatory provisions for an establishment, whose certificate of registration has been suspended or revoked, to request in writing a review within 30 days after the suspension or revocation to determine whether the certificate should be reinstated. Any inspection conducted in the course of the determination will be cost recovered in accordance with subsection 17(3) of the FIR. In order to have the certificate of registration reinstated, the establishment must submit a written Corrective Action Plan. The Corrective Action Plan should describe how they will achieve compliance. The certificate of registration may be reinstated when the Corrective Action Plan is reviewed and verified by an inspector as meeting the QMP requirements. Where a request has been made by an establishment to reinstate a suspended certificate of registration, the Agency will not initiate cancellation procedures until a determination referred to in subsection 17(2) of the FIR is made. 4.4 Product Action by CFIA Where the acceptability of product is brought into question through the identification of a deficiency or non-conformity during a compliance verification, and the establishment cannot resolve the problem as part of a Corrective Action Plan, inspectors are to take appropriate product action. Detention or seizure may be necessary to control fish products that are tainted, decomposed, unwholesome, fraudulently presented or otherwise fail to meet the requirements of the FIA, FIR or other applicable legislation. 5. COMPLIANCE AND ENFORCEMENT PROCEDURES - QMPi 5.1 Assessing a QMPi as Unacceptable A licence holder's QMPi will be assessed as unacceptable when a compliance verification has identified non-conformities and:
NOTE: When a critical non-conformity is identified during a compliance verification, the importer must be required to immediately develop a Corrective Action Plan and implement corrective actions to bring the system back under control. A thorough investigation across the entire QMPi plan must be conducted. Detention and seizure actions must be considered. It may be necessary to suspend and reschedule the compliance verification if the critical non-conformity is not satisfactorily addressed. When product with a potential consumer health and safety risk has entered commercial channels, the appropriate area/regional recall coordinator must be consulted regarding possible recall action for the implicated product. 5.2 Measures to be Taken for an Unacceptable QMPi 5.2.1 The importer has failed to develop an acceptable Corrective Action Plan Where the importer is unwilling or unable to develop an acceptable Corrective Action Plan, the following measures will be taken:
5.2.2 The importer has failed to meet the terms of a Corrective Action Plan and reach closure of the compliance verification Where the importer has failed to meet the terms of a Corrective Action Plan, the following measures will be taken: a) when the importer can demonstrate that actions have been taken and the terms of the Corrective Action Plan have not been reached through circumstances beyond the importer's control or time deadlines that have not proven realistic, then the importer may continue operating with new time frames for completion of the Corrective Action Plan, if the non-conformities are not likely to result in product which fails to meet all requirements of the FIR and other applicable legislation. A warning letter may accompany this option stating that failure to meet new time deadlines will result in a recommendation that the importer's licence be suspended. b) when the terms of the Corrective Action Plan have not been reached through negligence, deliberate inaction by the importer or inability of the importer, the same steps will be taken to suspend the licence as outlined in section 5.2.1. 5.2.3 The importer has a history of operating without proper controls and is unlikely to initiate an effective Corrective Action Plan Where the importer has a history of non-compliance and operating without the proper controls, the same steps will be taken to suspend the licence as outlined in section 5.2.1. 5.3 Request for Reinstatement of Import Licence Privileges Subsection 6.2(2) of the FIR sets out regulatory provisions for an importer, whose licence has been suspended or revoked, to request in writing a review within 60 days after the suspension or revocation to determine whether the licence should be reinstated. Any inspection conducted in the course of the determination will be cost recovered in accordance with subsection 6.2(3) of the FIR. In order to have QMPi privileges reinstated, the importer must submit a written Corrective Action Plan. The Corrective Action Plan should describe how they will achieve compliance. QMPi privileges may be reinstated when the Corrective Action Plan is reviewed and verified by an inspector as meeting the QMPi requirements. Where a request has been made by a person to reinstate a suspended licence, the Agency will not initiate cancellation procedures until a determination referred to in subsection 6.2(2) of the FIR is made. 5.4 Product Action by CFIA Where the acceptability of product is brought into question through the identification of a deficiency or non-conformity during a compliance verification of the QMPi, and the importer cannot resolve the problem as part of a Corrective Action Plan, inspectors are to take appropriate product action. Detention or seizure may be necessary to control fish products that are tainted, decomposed, unwholesome, fraudulently presented or otherwise fail to meet the requirements of the FIA, FIR or other applicable legislation. 6. COMPLIANCE AND ENFORCEMENT PROCEDURES - FISH IMPORT LICENCE 6.1 Non-notification of Imports Where an importer does not provide the Agency with an import notification in accordance with section 6 of the FIR, the first offence will normally result in a written warning being issued. If the product is available to the inspector, it will be detained until proper notification is received and inspection requirements determined. Subsequent offences will require an investigation for the purpose of determining whether prosecution action should be taken against the importer. In such instances, inspectors may seek advice, guidance and assistance from an investigation specialist within the EIS Division. 6.2 Moving Product Without Permission Where a fish import licence holder provides import notification but moves the product without permission, the inspector will detain the product to control its distribution. Detention will be maintained until the inspection requirements are determined. Where there is a question that detention is not adequate to ensure control of the product, the product will be seized according to the policies and procedures outlined in the Inspection Manual, Chapter 2, Subject 4. When product with a potential consumer health and safety risk has entered commercial channels, the appropriate area/regional recall coordinator must be consulted regarding possible recall action for the implicated product. In addition to the appropriate product action, a warning will be issued for the first offense. Subsequent offences will require an investigation for the purpose of determining whether prosecution action should be taken against the importer. In such instances, inspectors may seek advice, guidance and assistance from an investigation specialist within the EIS Division. 6.3 Unacceptable Record Keeping Where the importer is unwilling or unable to maintain records in accordance with subsection 6.1(3) of the FIR and the deterrence of other enforcement options have proven ineffective, the following measures will be taken:
6.4 Request for Reinstatement of Import Licence Privileges Subsection 6.2(2) of the FIR sets out regulatory provisions for an importer, whose licence has been suspended or revoked, to request in writing a review within 60 days after the suspension or revocation to determine whether the licence should be reinstated. Any inspection conducted in the course of the determination will be cost recovered in accordance with subsection 6.2(3) of the FIR. Where a request has been made by a person to reinstate a suspended licence, the Agency will not initiate cancellation procedures until a determination referred to in subsection 6.2(2) of the FIR is made. 6.5 Product Action by CFIA Where the acceptability of product is brought into question through the identification of a deficiency or non-conformity during an assessment of the importer's records or by other means, inspectors are to take appropriate product action. Detention or seizure may be necessary to control fish products that are tainted, decomposed, unwholesome, fraudulently presented or otherwise fail to meet the requirements of the FIA, FIR or other applicable legislation. 7. COMPLIANCE AND ENFORCEMENT PROCEDURES - IMPORTING WITHOUT A LICENCE Where fish is imported without a valid licence, the fish will be detained and the importer advised that an import licence is required or the fish must be removed from Canada. The importer should also be provided with an application for a licence to import fish. When the completed application and import notification are received, the process can begin to determine whether an inspection is required. If an application is not received after 30 days, the importer should be issued a written warning stating that unless the fish is removed from Canada or an application for an import licence is received within the specified time period, appropriate enforcement action including prosecution will be considered. If there is any attempt to move the fish without permission or if an application is still not received within 30 days of the warning, the fish should be seized (refer to Chapter 2, Subject 4 of the Inspection Manual) and consultation initiated with the EIS Division, if not previously done. NOTE: Future versions of this chapter may include compliance and enforcement procedures for suspension and revocation of permits and export licenses as well as refusal to issue licenses (import and export), certificates of registration and permits. Until such time, these actions will be taken as deemed appropriate by the Regional Director. |
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