Final report of an audit conducted in the United States of America to evaluate the food safety systems governing the production of meat and poultry products intended for export to Canada – January 23^rd to February 10^th, 2017
2 Competent authority and oversight

2.1 Training

IPP is the largest category of employees in the FSIS; with over 7,500 nationwide. All new inspectors receive an orientation training covering administrative tasks, code of conduct and professionalism. IPP is responsible for the on-line inspection in the slaughterhouse and basic training includes in-class and on-site training, shadowing and mentoring which lasts for 12-18 months. The offline consumer safety inspector (CSI) ensures that the plant is operating within its written plans for HACCP, sanitation, and processing. The CSI receives additional training in class and on-site about HACCP, sanitation standard operating procedures (SSOP), Information technology (IT), humane handling, ready to eat (RTE), RTE processed product, raw and heat treated products, export, and sampling. Furthermore, CSI training includes shadowing and mentoring with colleagues and supervisors.

The training of a new veterinarian employee includes orientation, inspection techniques, pathology, dispositions, supervisory training and enforcement, humane handling of animals, sampling and residue. The training is complete upon approval by a mentor.

AG learn is the learning management system containing FSIS specific courses for inspection program personnel, and used to maintain training records of FSIS employees. All employees have access to web-based training via AG Learn.

2.2 Supervisory oversight

The U.S. states are divided into 10 district areas with a variable number of states to supervise. The district offices (office of field operation) are responsible for the supervisory oversight of inspection staff. The front line supervisor (FLS) is under the supervision of the deputy district managers (DDM) who report to the district manager (DM) at the district office (D.O.). FLS has work unit meetings and monthly conference calls with the district office. The communication between the various management levels is completed via on-site visits, internet and phone calls. The DDM supervises and correlate the work of their FLS twice a year.

The IPPS (in-plant performance system) is the mandatory and statutory tool that supervisors use to assess the performance of non-supervisory in-plant inspection program personnel such as on-line IPP, CSI and public health veterinarians. An IPPS review can be conducted by the office of field operations supervisors including FLS, multi-IPPS supervisors, supervisory public health veterinarians and supervisory consumer safety officers.

A minimum of 2 IPPS assessments should be conducted for each employee per fiscal year. 3 methods are used to assess the performance of the inspection program personnel: observation, records review, and discussion. These are documented in the IPPS assessment sheet.

The supervisory tool for assessment results (STAR) is a tool that supervisors use to assess the knowledge and proficiency of field level supervisory personnel. The STAR allows determining whether in-plant, subordinate supervisors carry out both program activities and supervisory responsibilities. The STAR is used for supervisory public health veterinarians (SPHVs), supervisory consumer safety inspectors (SCSI), and supervisory personnel stationed at HACCP- based inspection models project (HIMP) establishments. At least one, in-person assessment must be conducted and documented for each covered employee during the rating cycle.

2.3 Regulatory enforcement

The USDA-FSIS PHIS is a web-based inspection tool allowing inspection staff to manage inspection activities and their history, such as inspection tasks and their status; NR; FSAs; MOIs; appeals to NR; direct links to NR, food safety assessment (FSA) and memorandum of interview (MOI). The regulatory enforcement is done on-site by the IIC (inspector in charge) and CSI in the establishments M and P and by the CSI in the V and I establishments.

In a situation of non-compliance, the FSIS has regulatory authority to retain/reject product, stop a line and refuse to allow the processing of specifically identified products. As per 9 CFR 500.2, the reasons for which the FSIS may decide to take a regulatory control action includes: unsanitary conditions or practices, product adulteration or misbranding, conditions that preclude FSIS from determining that product is not adulterated, misbranded or inhumanely handled or during slaughter. 3 types of enforcement actions defined in the 9 CFR 500.1 is:

• regulatory control action: the retention of product, rejection of equipment or facilities, slowing or stopping of lines, or refusal to allow the processing of specifically identified product
• withholding action: the refusal to allow the application of marks to be applied to products. A withholding action may affect all product in the establishment or product produced by a particular process; and
• suspension: an interruption in the assignment of program employees to all or part of an establishment

In a situation of non-compliance observed at official establishments, FSIS inspectors follow pre-determined steps to escalate the issue(s)

• MOI: If the non-compliance poses no food safety issue, then it is recorded and followed-up through a MOI.
• NR: If the non-compliance poses a food safety risk, or when non-compliance is not addressed by the operator through the MOI, then it is documented and followed-up through a NR. Each month the Office of Data Integration and Food Protection (ODIFP) uses the results of inspection tasks to calculate Public Health Risk (PHR) non-compliance rate for each official meat and poultry establishments. IPP then compares the establishment's NR rate to 2 set cut points (for early warning and for PHRE/FSA scheduling). A PHR alert will be issued to CSI and IIC when an establishment has a non-compliance rate that is elevated and is at or exceed the Noncompliance Cut Point for Early Warning. If this rate reaches a rate that is higher than the cut point for PHRE/FSA scheduling, a PHRE is to be scheduled. The PHR alert is discussed with the FLS.
• D.O.: If the non-compliance is not appropriately addressed by the operator through a NR, the issue can be escalated to the D.O. establishments with a PHR NR rate that exceeds the noncompliance cut point for public health risk evaluation (PHRE)/food safety assessment (FSA) scheduling will be listed in the PHRE/FSA monthly schedule. The non-compliance is then assessed through a risk prioritization tool (PHRE) which will determine if a FSA or notice of intended enforcement (NOIE) will be performed. The D.O. can decide to pursue immediately an enforcement action under 9 CFR 500.3 and issues a notice of suspension (NOS) letter. When the D.O. decides to immediately pursue an enforcement action under 9 CFR 500.4, such as withholding action or suspension with prior notification, it issues a NOIE letter. In connection with these enforcement actions, the D.O. prepares an administrative enforcement report (AER) case file to include all applicable information related to an establishment.

At the time of the audit, it was explained to the auditors that an establishment is not required to respond in writing to a NR. When IPP document noncompliance, the establishment must comply with regulatory requirements by correcting the noncompliance. In some situations, the establishment response will include documenting the corrective actions in the establishment SSOP or HACCP records. Providing FSIS a written/documented response to the NR is voluntary on part of the establishment. However, the establishment is responsible for bringing itself back into compliance. There is no specified timeframe in the regulations for establishment to correct a noncompliance described in an NR. However, the establishment should immediately addresses issues related to product adulteration or the creation of unsanitary conditions. In order to close a NR, the inspector must verify onsite if the non-compliance is addressed in a satisfactory manner. The NR can only be closed after inspection program personnel have verified that the establishment has met the requirements of 9 CFR 416.15 and 417.3. PHIS do not allow the inspection task to be designated as "completed" until IPP have verified and documented that the establishment has brought itself into a state of compliance.

High numbers of open and closed NR were observed in various establishments audited, many of which were related to the same causeCFIA auditors were informed during an interview that a NR can be linked with other similar repetitive NR for the first 90 days of a NR being issued; thereafter it is not possible to link the NR. As described in FSIS Notice 13-16, the links between NR serve as a marker to the PHIS system and identify a loss of control of the process.

If the non-compliance is related to egregious inhumane handling, the NR can be escalated to the D.O. level where the case analysis (documentation and on-site evaluation) is conducted by district veterinary medical specialist (DVMS). An egregious situation is any act or condition that results in severe harm to animals as defined in the FSIS directive 6900.2. The analysis may results to a letter of concern (LOC), a letter of warning (LOW) or finally Letter of suspension (LOS) issued by the D.O. to the operator with in specified time to make the necessary corrective actions.

2.4 Export controls

The FSIS CSI and/or IIC ensure exported US meat and poultry products have passed the inspection by FSIS and comply with any additional requirements of the importing country. The operator completes signs and dates FSIS Form 9060-6 "application for export certificate". Upon receiving an application for export, the CSI reviews the application to verify that it is complete and also that the requirements of the receiving country have been met. The establishment's CSI verifies establishment and product eligibility in the export library published on the USDA's website before assigning an export certificate number to the lot. At the opening meeting, auditors were informed that the export library is an FSIS listing of export requirements that had been agreed between CFIA and FSIS.

The Meat, Poultry and Egg Product Inspection Directory is a listing of all US establishments that produce meat, poultry, and/or egg products regulated by USDA's FSIS for the domestic market and/or for exportation. This directory of establishments is updated monthly.

As part of the export verification task, the inspector conducts an on-site inspection of the product to be exported, verifies the presence and apposition of the official mark of inspection, the integrity of the packaging material, and signs and dates the application before providing the applicant with an unsigned export certificate to complete. Sometimes, the I-establishments are located at the same location as V establishments used to export products. In these situations, activities of verification of importation (I) and activities of verification under the grant of V establishments such as exportation, re-packaging, relabelling can be performed in the same building. However, separate inspectors, separate tasks and separate offices are assigned to the establishment type I and V.

It was confirmed during the audit that the U.S. export certificate contains only the information of the last exporting and/or processing establishment. No information is available on the slaughter house and the chain of processing establishments where the meat and meat products were produced. This fact leads to a lack of information regarding the source of the meat (slaughterhouse, country of origin). It can cause difficulty to verify information about animal health status and food safety status of the products. These facts are essential to verify the export eligibility of the products and when situation of recalls and investigation is triggered in case of fraud are present. As described in the MOP chapter 11.2.5.1, the name, address and registration number of the slaughter, processing establishment and the consignee are described in the Canadian export certificate.

After the verification of the application and the product, the unsigned certificates are provided to the operator one at a time and kept under locked with records at the FSIS office. The FSIS inspector keeps control of the official stamp or can give a pre-stamp authorization to the operator when a printer is used to produce larger number of stickers with the official inspection mark. In case of non-compliance situation, the operator may lose the pre-stamp authorization provided by the FSIS. Unused stickers are destroyed by the inspector.

Effective February 1, 2017, Canada no longer requires a veterinarian to sign FSIS forms 9135-3 and 9135-3A, but veterinarian signature is required for all letterhead certificates accompanying the products and when the animal health attestations are added to the "remarks" section of FSIS forms 9135-3 and/or 9135-3A.

When export certification services are performed in an official establishment (M and P establishments), the issuance of export certificates required by 9 CFR part 322 and 381.104 through 381.111 are not reimbursable services. In the V establishments, any certification and signature of certificates that is in addition to the FSIS regulatory requirements as described in 9 CFR 322.3 are considered reimbursable services. Per example, additional certification required by the importing country and the transferring of products for export is considered as reimbursable services.

Establishments eligible to export product to Canada are required to stun poultry prior to slaughter as per Canada's country requirements found in the export library. As indicated in FSIS Directive 9000.1, inspection personnel must verify country requirements as posted in the FSIS export library prior to certifying products on the export certificates (FSIS form 9135-3 for Canada). As per the export library, FSIS is required to certify that birds were subjected to humane slaughter and were effectively stunned before slaughter. During the audit of a poultry slaughter establishment, it was explained that monitoring of appropriate poultry stunning was performed by the operator via their good commercial practices (GCP). It was understood via interview that FSIS verifies the operators' monitoring of this Canadian import requirement through their regular poultry GCP verification task. As described in FSIS directive 6100.3, FSIS verifies stunning procedures during the GCP task and findings are documented in the PHIS.

The letter of attestation regarding the monitoring of the effectiveness of the poultry stunning is issued annually by the slaughterhouse operator. The attestation is provided to the U.S. establishment responsible for the export of the poultry meat when it is not the producing establishment. Prior to signing the export certificate, FSIS inspectors rely on the letter of attestation for stunning shared between the operators to ensure that Canadian import requirements are met. The letter of attestation was not corroborated by the FSIS inspection personnel in contrast to the Canadian export verification procedure explained in the Canadian meat hygiene manual of procedures (11.2.4.2).

No clear definition of "processing" is available in the 9 CFR 301.2 only the term prepared as defined as slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed. As specified in 9 CFR 327.18 all products, after entry into the United States, shall be deemed and treated as domestic products.

2.5 Grant of inspection

An applicant can request a grant of inspection by sending an application to the D.O. Different application forms are completed for official M, P and I establishments and voluntary inspection facility establishments (V). The D.O. processes the application and the district managers (DM) decide that inspection service should be provided to the establishment.

16 different categories of V establishments are identified in 9 CFR 362.2. To register as a V-establishment, the operator must first apply to FSIS for voluntary reimbursable inspection services. The applicant must meet the general requirements of the regulatory requirements under the Federal Meat Inspection Act and Poultry Products Inspection Act 9 CFR, Chapter III, 416.1 to 416.6. The DM instructs a designee to visit the facility to determine whether it meets the general requirements for the service requested.

Only certification, identification and food inspection services at V establishments were observed during the audit. The V establishments perform voluntary inspection services for the certification of export. Furthermore, the V establishments with identification service (meat and poultry) perform activities of division of the meat and poultry product into smaller portions, its combination into larger units, or its repackaging and relabelling. In these Identification establishments, the regulations do not permit any product reconditioning, "ice glazing," or other types of further processing operations, such as cutting, boning, or trimming, which must take place at official establishments (M or P). Processing of certain food articles not covered by the FMIA or PPIA is permitted in establishments under USDA inspection as a reimbursable service (V establishments).

USDA has set a rule that any food product containing the following is not subject to the FMIA or PPIA and to FSIS inspection: (1) 3 % or less raw meat or less than 2 % cooked meat, or (2) less than 2 % cooked poultry meat, less than 10 % of cooked poultry skins, giblets, or fat, separately, and less than 10 % of cooked poultry skins, giblets, fat, and meat in combination, or specific condition provided the poultry ingredients were prepared under domestic or foreign inspection and the product is not represented as a poultry product.