Final Report Of An Audit Conducted In The United States February 5th, through February 22nd, 2013 Evaluating The Food Safety Systems Governing The Production Of Meat And Poultry Products Intended For Export To Canada
5. Government Oversight

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Canadian import eligibility requirements dictate that the foreign inspection system be organized and administered by the Federal government of the foreign country and that this system provides standards equivalent to those of the Federal meat and poultry inspection system in Canada. For the United States, the authority to enforce USDA inspection laws is granted in the Federal Meat Inspection Act and Regulations, and the Poultry Products Inspection Act and Regulations, and is exercised through USDA-FSIS Directives and Notices.

During the audit, there were no systemic findings related to organizational structure and inspection staffing, supervision, assignment of competent qualified inspectors, authority and responsibility to enforce the laws, and administrative-technical support including laboratory oversight.

It was observed in two (2) establishments that the legal authority and the responsibility to enforce all applicable laws and regulations governing American and third-country requirements were not consistently applied by the CCA throughout the system:

  • In both of these establishments, pre-operational and operational sanitation (SSOPs) deficiencies were observed throughout the facilities (on the slaughter and processing sides).
  • In one of the 2 establishments, animal welfare issues were observed which are not equivalent to Canadian standards.

During the audit visit to these two (2) specific establishments, USDA-FSIS auditors and local inspection staff reacted appropriately to the non-compliant situations. Auditors and inspectors worked cohesively to ensure that identified issues were handled promptly and effectively at these establishments. Establishments developed and implemented corrective actions and preventive measures addressing the concerns identified during the audit. Following USDA-FSIS and CFIA's review of the action plans the two (2) establishments remained eligible to export to Canada.

While CFIA expects these actions to occur in relation to the CCA's ongoing responsibilities for inspection and for oversight of its inspection personnel, these events carry a different significance when they occur within the context of a CFIA audit, as it calls into question why the conditions within a particular establishment have gone unchecked and escalated to the level where an enforcement action is necessary.

An important subcomponent of this equivalence verification audit was to ensure the assignment of competent, qualified and trained inspectors. The USDA-FSIS is responsible for the hiring, training, assigning, and overseeing inspection personnel.

The USDA-FSIS Public Health Information System (PHIS) is a web-based inspection tool allowing inspection staff to manage each inspection activity and history, including: inspection tasks and their status; NRs; FSAs; MOIs; appeals to NRs; and the USDA-FSIS sampling history for assigned establishments, including direct links to NRs, FSAs and MOIs. The CFIA auditors determined through interviews with USDA-FSIS inspection staff that the staffs were able to adequately explain and demonstrate the PHIS to the auditors. However, when the CFIA auditors examined the inspection tasks within the PHIS, they learned that the tasks did not include any instructions to the inspection staff on how to assess compliance to the regulations, but instead only included a title and reference to legislations. This situation creates the potential for inconsistent application of the same task between different inspectors, as the application of the task relies on how the individual inspector decides to execute the task. In addition, the PHIS did not provide explicit instructions to inspectors on how to document details of an establishment operator's corrective action plans following the issuance of a NR or following a POE violation; nor how to specifically do the follow-up required after an NR is issued. This situation meant that USDA-FSIS inspectors were not able to explain and demonstrate that they were applying PHIS in a uniform and consistent manner to CFIA auditors. The CFIA auditors note that the PHIS is a new system that needs further refinement to ensure that all tasks activities are conducted as intended and at required frequencies.

FSIS Response:

The intent of PHIS is not to provide instructions on how to assess compliance to the regulations. Rather, FSIS uses various policy issuances such as FSIS Directives, Notices, and answers provided via AskFSIS to assist Inspection program personnel (IPP) on how to verify regulatory compliance. FSIS provides documents that provide the "instructions" on how to verify regulatory compliance when performing specific tasks. The documents provide instructions for HACCP, SSOP, SPS and OCP verification tasks (e.g. net weights, Finished Product Standards verification, etc.), including "documentation" instructions that include references to the following issuances or resources:

  1. FSIS Directive 5000.1 PDF (424 kb)
    FSIS Directive 7000.1 PDF (199 kb)
    13,000 Series: Public Health Information System (PHS) PDF (424 kb)
  2. FSIS Notices,
  3. askFSIS Q&As,
  4. and FSIS regulations.

FSIS evaluates performance of individual IPP annually. Employee performance is documented using IPPS (In-Plant Performance System) Reviews. Supervisory personnel evaluate IPP knowledge and application of FSIS policies, requirements, procedures to achieve FSIS strategic goals at each assignment on an annual basis. FSIS ensures IPP are familiar with the regulations they verify and know how to perform their tasks per instructions in the applicable directive or notice. In addition to assessing IPP performance, FSIS also assesses the effectiveness of our instructions to the field and updates them as necessary based on that analysis. If they have questions, they can contact their supervisor, review Questions and Answers (Q&As) posted in askFSIS, submit a question to FSIS Office of Policy and Program Development (OPPD) through askFSIS or call the FSIS Policy Development Staff (PDS) at 1-800-233-3935.

FSIS IPP does not typically document establishment corrective actions. Rather, IPP verify the establishment has documented daily records that establish the establishment's implementation and monitoring and any corrective actions. IPP perform verification tasks to determine whether establishments meet HACCP and SSOPs requirements via direct observations and recordkeeping. In PHIS, NRs cannot be closed until the establishment has re-established regulatory compliance. See PHIS Methodology in FSISDIR 13,000.1I PDF (212 kb). IPP know details of corrective actions are documented in HACCP and SSOP records. IPP have opportunities to discuss noncompliance as well as corrective actions performed in weekly meetings with establishment management. Such discussions are documented in Memoranda of Interview (MOIs). Ref. FSIS DIR 5000.1. Establishments have the option to provide a response via PHIS.

Non-Compliance Status:
Status in PHIS Definition
Non-Compliance (NC) Open
  • A non-compliance has been documented on and NR
Finalized
  • The non-compliance is ready to deliver to establishment management
Non-Compliance Record (NCR) Open
  • An NR has been created in PHIS
Completed
  • All of the mandatory regulations have been verified;
  • The establishment has brought itself into compliance with the regulations for each non-compliance in the NR.

The PHIS schedules follow-up tasks after noncompliance, particularly in the case of HACCP and SSOP noncompliances or positive FSIS test results for adulterants.

Overall, during inspection staff interviews, USDA-FSIS inspectors were able to convey their knowledge and understanding of the expected roles and responsibilities of their position. The competence demonstrated by inspection staff indicated that the USDA-FSIS system for inspector training and periodic reviews is sound and effective.

The auditors noted a number of similar minor shortcomings in many of the facilities visited as part of the on-site phase of the audit. Refer to sections 6, 7, and 8 for specific information. The shortcomings were addressed appropriately at the time of the visit, but suggest that certain inspection or oversight tasks may not be entirely effective at achieving the degree of prevention expected from the establishment operator under HACCP.

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