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Canada's proposed National Framework for African Swine Fever Compartments

This page is part of the consultation on Canada's national standards and framework for African swine fever (ASF) compartments. The consultation will be open from March 18, 2022 to June 16, 2022. Input gathered through this consultation will help shape Canada's national standards and framework for ASF compartments.

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Introduction

The national requirements that set the foundations for Canada's National Compartmentalization Program (NCP) for African swine fever (ASF) are detailed across 2 documents:

  1. The national standards
    Details requirements that the farm-level ASF compartment program must meet. The Canadian Food Inspection Agency (CFIA) will assess all submitted farm-level / establishment ASF compartment programs against these requirements.
  2. The framework
    The framework document details all of the requirements for the administration and implementation of an ASF compartment program. Examples of requirements found in the framework document include (but are not limited to):
    • roles and responsibilities of the various parties involved in an ASF compartment program
    • procedural administrative requirements related to appeal, suspension, revocation
    • compliance verification requirements such as credentials of third parties involved in the program, frequencies and nature of audits as well as required documentation
    • procedural steps and timelines for applications

The requirements outlined in both the national standards and framework must be met by all associated parties in order for CFIA to recognize and endorse an ASF compartment program.

The national standards and framework requirements will be reviewed at a minimum annually, or sooner as required based on new scientific information, international guidelines, or by the consensus of a review panel.

A third component, the Compartment Operators Program (COP) completes the suite of requirements necessary for the NCP. This component will be mentioned but as it is not one of the foundational elements, it will not be discussed in this consultation. Participation in NCP however, once compartment operators are enrolled in the NCP, their compliance with the national standards, the framework and the COP is mandatory.

1. Roles and responsibilities

1.1 Competent veterinary authority

This role and the associated responsibilities will be assumed by the CFIA in all situations. The competent veterinary authority is ultimately responsible for establishing and overseeing the integrity of the Canadian ASF Compartment Program. The CFIA accomplishes this through performing the following roles:

1.2 Administrator

This role and the associated responsibilities are assumed by the Canadian Pork Council (CPC). The administrator is responsible for overseeing the implementation of and participation in the NCP, including the following:

1.3 Compartment auditor

This role and the associated responsibilities is assumed by auditors who have been trained and hired by the administrator, and certified by the CFIA. COP audits must be completed with a minimum of 2 auditors per compartment. A COP auditor is responsible for verifying an operator's compliance with the COP, including the following:

1.4 Network laboratories

Laboratories must be approved and recognized by the CFIA as part of the Canadian Animal Health Surveillance Network (CAHSN) and approved to perform ASF testing for surveillance purposes. Approved network laboratories providing diagnostic testing services for the NCP are responsible for the following:

1.5 Compartment operator

In the NCP, a compartment owner is an individual, partnership, company, corporation or other legal entity that has legal or rightful title to a swine production business enrolled as an ASF compartment, regardless of any lien(s) held on the business. A compartment operator is a designated individual, partnership, company, corporation or other entity responsible for the management and operation of a compartment; the compartment operator may or may not be the compartment owner. Compartment operators are responsible for:

1.6 Compartment associated facilities operator

In the NCP, the owner of a facility associated with a compartment is an individual, partnership, company, corporation or other legal entity that has legal or rightful title to a business that is required by a compartment owner / operator in order to carry out all of the necessary management and biosecurity functions associated with being an ASF compartment. An operator of such a compartment associated facility is a designated individual, partnership, company, corporation or other entity responsible for the operation of a facility required by a compartment such as a feed mill, a truck wash facility, an AI centre, an abattoir or a processing plant; the operator of the compartment associated facilities may or may not be the owner of the compartment associated facilities. A compartment associated facility may be associated with one or more compartments owned and operated by different individuals or companies. Compartment associated facilities not owned by the compartment will require their own separate approval status based on the documents they submit during the application process and the outcome of the audits (document and on-site) performed by the compartment administrator and the certified auditors for the compartment. Operators of a compartment associated facilities are responsible for:

2. Administration

2.1 Compartment enrollment process

2.1.1 Application

The individual, partnership, company, corporation or other entity wishing to become a compartment must contact the administrator and request an application package.

An application package is completed and submitted back to the administrator. The application must be accompanied by:

The administrator performs an initial application review to confirm that all necessary documentation has been submitted by the applicant. If the initial application review is found sufficient by the administrator, a documentation review is undertaken. During this review, all of the applicant's documentation is assessed to verify that it is compliant with the national standards and the COP requirements as follows:

2.1.2 Qualification period

A qualification period must be observed by the compartment applicant prior to starting the COP initial audit. The requirements of this qualification period differ based on the ASF status of the zone in which the compartment applicant`s premises reside.

2.1.2.1 Qualification period for compartment applicants in an ASF-free zone

Prior to the initial on-site audit, all components of the applying compartment and associated facilities' management and system operating manuals must be implemented and documented. At least 3 months of records demonstrating adherence to the compartment and associated facilities' management and system operating manual are required. The only exception is records pertaining to surveillance, for which the accumulation of sufficient data to demonstrate ASF freedom, as per the applicant's surveillance plan component, is adequate. Qualification period records can be accumulated prior to application submission and up to the start of the COP initial audit.

2.1.2.2 Qualification period for compartment applicants in a non ASF-free zone

During the qualification period, all components of the applying compartment and associated facilities' management and system operating manuals must be implemented and documented. At least 3 months of records demonstrating adherence to the compartment and associated facilities' management and system operating manuals are required. The only exception is records pertaining to surveillance, for which the accumulation of sufficient data to demonstrate ASF freedom, as per the applicant's surveillance plan component, is adequate. Qualification period records cannot be accumulated prior to application submission, and must only begin once the application has been found acceptable. Qualification period records must be complete prior to the start of the Compartment Operator Program initial on-site audit.

2.1.3 Compartment Operator Program initial on-site audits

An initial on-site audit of the compartment applicant premises must occur to verify that the COP requirements have been implemented adequately by the compartment applicant according to their approved compartment management and system operating manual. If the compartment applicant is using an associated facility owned by the compartment then the audit of the associated facility can occur in conjunction with the compartment applicant premises and facilities audit. This audit takes place after a compartment`s initial application and documentation review have been deemed satisfactory and all qualification period requirements have been met. COP initial on-site audits are carried out by auditors who have been approved by the administrator and certified by the CFIA to conduct COP audits for the NCP.

An on-site audit of all external compartment associated facilities must occur to verify that the COP requirements have been implemented adequately by any facility under agreement with the compartment operator.

Deviations from the applicant's compartment operating manual will result in the issuance of a corrective action request (CAR). CARs will be issued and handled by the attending auditor team, with or without the involvement of the administrator depending on the severity of the deviation. The compartment operator or compartment associated facility operator is responsible for implementing measures to resolve any CARs within the timeframe prescribed by the auditor team or administrator. All CARs must be closed on all premises / facilities prior to the administrator recommending to the CFIA to approve the applicant's enrollment to the compartment.

2.1.4 Compartment Operator Program audit reports review

The report generated by the auditor attending the initial on-site audits of the compartment and associated facilities are reviewed by the administrator. If a compartment associated facility which has already been approved by the administrator and is in good standing is identified by the compartment applicant, there is no need for an additional facility audit and report review. If the findings of the audits are found to be satisfactory by the administrator, and there are no outstanding CARs, the administrator makes a recommendation to the CFIA for approval of the compartment.

2.1.5 Compartment approval

Administrator recommendations for compartment enrollment are reviewed by the CFIA. The CFIA makes the final decision to approve or reject enrollment of a compartment. A list of all approved and enrolled compartments will be made publicly available on the CFIA's website.

2.2 Ongoing assessment of an approved compartment

2.2.1 Annual compartment summary report

An operator of an enrolled compartment must submit an annual compartment summary report to the administrator. The report must provide information on the compartment's surveillance activities, live animal or germplasm movements into the compartment, modifications to biosecurity procedures in the compartment operating manual or any of the associated facilities operating manuals, and any other information as outlined in the Compartment Operator Program.

2.2.2. Annual compartment audit

A full audit of all approved compartment premises and all compartment associated facilities is required annually. A full audit includes both a documentation audit and an on-site audit. Significant deviations from the approved compartment operating manual or the compartment associated facility operating manual, which documents compliance with the COP, will result in the issuance of a CAR. CARs issued as part of an annual compartment audit are handled by the attending auditor, with or without involvement of the administrator depending on the severity of the deviation. The operators of the compartment and the compartment associated facilities are responsible for implementing measures to resolve any CARs within the timeframe prescribed by the auditor team or administrator. All CARs must be closed for consideration of ongoing approval of the enrolled compartment and / or compartment associated facilities.

2.2.3 Approval

The administrator reviews the annual compartment summary report, the annual compartment audit report, and the annual compartment associated facility audit report. If the administrator is satisfied with the review, and all CARs have been closed within the prescribed timeline, the compartment's approved status in the NCP is maintained.

2.3 Suspension/revocation/withdrawal

2.3.1 Suspension

Suspension means the temporary removal of an approved compartment from the NCP. A compartment is suspended from the NCP when:

The administrator is responsible for suspending a compartment found to meet the above conditions. However, the CFIA can also notify the administrator should the CFIA become aware of a compartment premises or a compartment associated facility suspected or confirmed to meet the above criteria. The administrator must investigate and respond to all notifications issued by the CFIA.

When an enrolled compartment is suspended by the administrator, the compartment is no longer considered part of the NCP until such a time the suspension is lifted. The administrator informs the CFIA when a compartment has been suspended, and the CFIA takes the necessary actions in accordance with bilateral trade agreements with international trading partners, and updates the publicly available list of enrolled compartments accordingly.

If compartment associated facilities are to be associated with more than one compartment, they must have their own approval status. If the suspension of the compartment includes non compliant measures at a compartment associated facility then the compartment associated facility will have its approval suspended as well. This suspension will have ramifications for any other compartment using that associated facility. If the suspension of the compartment does NOT include any non compliances at a compartment associated facility then the associated facilities will maintain their approved status. This allows them to continue to operate as part of another compartment with which they have an established agreement.

2.3.2 Reinstatement of a suspended compartment

The administrator is responsible for handling all compartment and compartment associated facility suspensions and outlining the procedures for reinstatement of a suspended compartment. The suspended compartment premises and all compartment associated facilities must continue to observe all requirements of the COP during the suspension period to be eligible for reinstatement. When the administrator reinstates a suspended compartment or compartment associated facility to the NCP, the administrator must notify the CFIA. The CFIA will reinstate certification of the compartment and/or the compartment associated facility, notify trading partners of the compartment's reinstatement if the CFIA notified the country of the suspension in accordance with bilateral trade agreements, and update the publicly available list of enrolled compartments accordingly.

If the suspended compartment or compartment associated facility is unable to comply with the administrator's requirements for reinstatement after reasonable process, the administrator will revoke the compartment's enrollment.

2.3.3 Revocation

Revocation means the removal of a previously approved compartment from the NCP. A compartment will be revoked from the NCP when:

The administrator is responsible for revoking a compartment's enrollment when the compartment is found to meet the above conditions. However, the CFIA can also notify the administrator should the CFIA become aware of a compartment suspected or confirmed to meet the above criteria. The administrator must investigate and respond to all notifications issued by the CFIA.

When a compartment's enrollment is revoked by the administrator, the compartment is no longer a part of the NCP. The administrator informs the CFIA when a compartment's enrollment has been revoked, and the CFIA ceases certification of the compartment, notifies trading partners, and updates the publicly available list of enrolled compartments accordingly.

If compartment associated facilities are associated with more than one compartment, they must have their own approval status. If a compartment associated facility has their compartment status revoked, this will have ramifications for any other compartment using that associated facility. If the revocation of the compartment does include any non compliant actions by the compartment associated facility then the associated facilities will maintain their approved status. This allows them to continue to operate as part of another compartment with which they have an established agreement.

2.3.4 Re-enrollment following revocation

Re-enrollment following the revocation of a compartment or compartment associated facility from the NCP may be considered at the discretion of the administrator. A compartment or compartment associated facility whose enrollment has been revoked must re-apply to become part of the NCP, and meet all requirements as outlined in the compartment enrollment process.

2.3.5 Voluntary withdrawal

An operator of a compartment or a compartment associated facility who wants to voluntarily withdraw from the NCP must notify the administrator of the withdrawal. The administrator must subsequently notify the CFIA of the voluntary withdrawal of any approved compartment or compartment associated facility.

2.4 Appeals

2.4.1 Eligibility for appeal

A compartment operator may appeal the administrator's decision to suspend or revoke enrollment of a compartment or a compartment associated facility, but not both suspension and revocation. An operator of a compartment or compartment associated facility may also appeal a decision made by the administrator regarding conditions imposed before the compartment or compartment associated facility is permitted to be reinstated or to re-apply to the NCP after a suspension or revocation. An appeal of the administrator's decision is not available if the revocation of the compartment or compartment associated facility status is due to confirmation by the CFIA of the presence of the ASF virus.

2.4.2 Appeal process

The administrator must design an appeal process. At the request of the operator of a compartment or compartment associated facility, the administrator will implement the appeal process to consider any submitted appeals. The appeal committee will provide the CFIA with a recommendation as to whether the appeal should be accepted. The CFIA will make the final decision as to whether the appeal will be accepted.

2.4.3 Appeal committee composition

The administrator will manage and appoint members to the appeals committee. The appeals committee membership will achieve adequate representation, and will include:

2.5 Reporting

Information sharing requires that all compartment information relevant to ASF or the animal population of the compartment be available to the compartment operator, the administrator, and the CFIA. The CFIA will maintain a publicly available list of all approved compartments and compartment associated facilities on the CFIA's website. The compartment operator and compartment associated facility operators must agree to allow publication of current information pertaining to their compartment, as per the administrator's procedures, under the NCP at all times.

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