Integrated Agency Inspection Model – Consultation Draft (December 4, 2013)
8.0 Regulatory Response
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The CFIA has a mandate to respond to events that are initiated by lack of compliance on the part of regulated parties and by events that are the responsibility of the Agency to control, such as pest and disease incursions and contaminant events.
The CFIA responds to lack of compliance by regulated parties and is responsible for controlling pest, disease incursions and contaminant events.
This response includes various activities as described in the CFIA's Compliance and Enforcement Policy. The model proposes to apply a single, consistent policy across all commodities that are transparent and appropriate.
For more information, see the Compliance and Enforcement Operational Policy on the CFIA's website.
As the regulatory frameworks are modernized, this policy will be reviewed and updated as required.
The processes that lead to inspection decisions—or compliance and enforcement actions—must be objective, impartial and equitable. They must be in keeping with the CFIA's values and ethics and respect the regulated party's rights.
The appropriate level, type and extent of response will depend on a range of factors, including
- the potential for harm, such as
- the degree to which non-compliance has impacted or has the potential to impact human, animal or plant health, or the environment
- the magnitude of the non-compliance (critical, serious, technical)
- whether the commodity is within the regulated party's control
- the intent of the regulated party, including
- whether non-compliance was intentional, accidental or negligent
- the extent to which the regulated party had exercised due diligence
- the regulated party's demonstrated performance, including
- its compliance history
- the history of complaints
- the level of commitment by management
Specific responses could be directed at the commodity (e.g. quarantine or detention) and/or the regulated party (e.g. issuance of a corrective action request). The inspector has the flexibility to select the appropriate response based on the situation. The range of CFIA regulatory actions can be found in the tools listed in Annex D. Figure 4 - Regulatory Response, illustrates the two streams of the CFIA's regulatory response and how they have the potential to interact with each other. Further detail on the activities within each stream is provided below.
8.1 CFIA response to non-compliance on the part of the regulated party (Figure 4 - Yellow stream)
The compliance and enforcement strategy is based on the principle that the regulated party is responsible for producing safe food, and healthy animals and plants that comply with regulatory requirements. CFIA's response is directed at the regulated party, including those who hold permissions and do not comply with regulatory requirements. The corrective measure must be carried out by the regulated party. The response to non-compliance follows:
Trigger: The CFIA becomes aware of, or conducts an inspection that, establishes non-compliance.
A formal request is issued to the regulated party to comply. This could take the form of a corrective action request or inspection report of technical violation.
If there is critical or serious non-compliance, any affected commodity is controlled and the non-compliance is addressed to prevent recurrence.
For example, an importer who has a history of importing non-compliant commodities may be required to submit evidence of compliance before the CFIA would give permission to import. The importer could be required to provide the CFIA with documentation from an accredited laboratory or other documented evidence of analytical results demonstrating compliance for five consecutive shipments following the finding of a non-compliant importation.
The CFIA conducts a follow-up inspection to confirm that effective corrective actions have been implemented and that any changes to a preventive control plan has been documented.
Failure to satisfactorily resolve the non-compliance results in enforcement actions by the CFIA.
8.2 CFIA response to a reportable pest, disease or contaminant event where the CFIA imposes control measures (Figure 4 - Grey stream)
In the case of a regulated animal disease, plant pest incursion or contaminant event in Canada, premises with or without licences may be subject to regulatory control actions to limit the spread as follows:
Trigger: When the CFIA becomes aware of the potential presence of a pest, disease or contaminant, an inspection to confirm its presence is performed. Regulatory control actions may be applied at this stage depending on the level of risk. Confirmatory testing will be performed according to established procedures.
If at any point it is discovered that the producer is in violation of legislation of their own volition, the CFIA will respond with appropriate compliance and enforcement actions. This response is described in 8.1 – CFIA response to non-compliance on the part of the regulated party.
CFIA Response Phase 1: Initial Management
The CFIA determines the scope of regulatory control actions and appropriate response required to contain or remove the contaminant, pest or disease. Control actions may include quarantine, seizure and detention, recall, disposal, etc.
These regulatory response activities continue until:
- the threat is removed from the premises; or,
- a policy decision is taken that it is more appropriate to de-regulate the contaminant, pest or disease rather than continue to attempt control or eradication; or,
- a long-term management option is chosen.
CFIA Response Phase 2: Long-Term Management
When eradication is not possible or takes several years, the CFIA may order control actions that may include the establishment of regulated areas and movement and production controls. Licences with preventive control plans are required, for example, to demonstrate that the movement of commodities or regulated things will not result in the spread of the disease or pest.
A licence of this type may also be used for international trade out of compartments or recognized special status premises.
The CFIA recognizes that, for many regulated parties, the transition to this integrated inspection model would require time to:
- develop and document a preventive control plan (if required),
- make changes to their practices,
- adapt to the risk-based approach described in the model, and
- apply for a licence.
The CFIA understands that many regulated parties' business models would need to evolve. As part of its compliance promotion strategy, the CFIA intends to provide technical and educational outreach in a variety of formats. This would help facilitate transition as regulated parties gather information and interact with the CFIA online and in person (e.g. an online labelling tool, generic model systems). Compliance promotion complements rather than diminishes the CFIA's ability to take enforcement action.
Transitional enforcement guidelines would also be used in the initial stages of implementing the model.
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