Final Report of a Maintenance Audit Conducted in United States of America to Evaluate Meat Inspection Systems Governing the Production of Meat and Meat Products Intended for Export to Canada - August 1 to 10, 2023 and October 17 to 26, 2023

On this page

• Abbreviations and special terms used in the report
• 1. Executive summary
• 2. Introduction
  • 2.1. Audit objective, scope, and methodology
  • 2.2. Legal basis for the audit and audit standards
• 3. Competent authority and oversight
  • 3.1. Regulatory framework
  • 3.2. Oversight framework
  • 3.3. Training framework
  • 3.4. Export controls
  • 3.5. Import controls
  • 3.6. Enforcement framework
  • 3.7. Laboratory framework
• 4. Ante-mortem, humane handling and animal welfare controls
  • 4.1. Traceability and animal identification
  • 4.2. Ante-mortem inspection
  • 4.3. Humane handling and animal welfare
• 5. Slaughter and post-mortem
  • 5.1. Bovine (Beef)
  • 5.2. Swine
  • 5.3. Poultry
• 6. Processing controls
  • 6.1. Antimicrobial controls
  • 6.2. Chilling/Cooling and freezing controls
  • 6.3. Retained water control program
  • 6.4. Allergen control program
  • 6.5. Lethality controls
• 7. Preventive control plans
• 8. Microbiological controls
  • 8.1. FSIS sampling plans
  • 8.2. Operator sampling plans
• 9. Chemical residue controls
• 10. Closing meeting
• 11. Conclusions
• 12. Recommendations

Abbreviations and special terms used in the report

APHIS

Animal and Plant Health Inspection Service

CCA

Central Competent Authority

CFIA

Canadian Food Inspection Agency

CFR

Code of Federal Regulations

CSI

Consumer safety inspector

EV

Export verification

FCS

Food contact surface

FDA

Food and Drug Administration

FSA

Food safety assessment

FLS

Front Line Supervisor

FMIA

Federal Meat Inspection Act

FSIS

Food Safety Inspection Service

HIMP

HACCP Based Inspection Model Project

IIC

Inspector in charge

IPP

Inspection program personnel

IPPS

In-plant Performance System

LIMS

Laboratory Information Management System

MOI

Memorandum of interview

NR

Non-compliance record

NPIS

New Poultry inspection System

NSIS

New Swine Inspection System

OFO

Office of field operation

PPIA

Poultry Products Inspection Act

PHIS

Public Health Information System

RTE

Ready to eat

SRM

Specific risk material

SSOP

Sanitation standard operating procedures

USDA

United States Department of Agriculture

1. Executive summary

This report describes the outcome of an onsite audit of the meat inspection system governing the production of meat and meat products in the United States of America (hereafter referred to as the U.S.) intended for export to Canada. The Canadian Food Inspection Agency (CFIA) conducted the audit from August 1 to 10, 2023, and October 17 to 26, 2023. The opening and closing meetings were held virtually with the Central Competent Authorities (CCA) on July 27, 2023, and November 30, 2023, respectively.

The objective of the audit was to verify that the meat inspection system governing meat and meat products in the U.S. functions in a manner determined to be equivalent to those of Canada, for example, producing meat and meat products that are safe, wholesome, unadulterated, and properly labelled. The evaluation focussed on the verification of activities within the following subject areas:

• Competent authority and oversight
• Ante-mortem, humane handling and animal welfare controls
• Slaughter and post-mortem controls
• Processing controls
• Preventive control plans
• Microbiological controls
• Chemical residue controls

The audit results showed that the meat inspection system governing the production of meat and meat products in the U.S. is performing adequately, with overall controls that are equivalent to those in Canada. The audit report includes the key conclusions and provides recommendations to the U.S. based on observations made during the on-site audit.

2. Introduction

2.1 Audit objective, scope, and methodology

The purpose of this audit was to verify if the U.S. continues to implement a meat inspection system equivalent to that of Canada and if the system can produce safe, unadulterated, and properly labelled meat products for export to Canada. The last maintenance audit was conducted by CFIA in 2019. The final report of this audit is available on the CFIA website.

CFIA continues to work with FSIS to resolve the 2019 audit recommendations:

• Implement procedures to segregate Canada eligible and ineligible meat and meat products at establishments approved for export to Canada.
• Implement procedures to ensure that ante-mortem poultry inspection from each farm is completed not more than 24 hours before the slaughter.
• Ante-mortem and post-mortem inspection at bison slaughter establishment.

The U.S. is Canada's major trading partner. In 2022, the U.S. exported meat products valued at U.S.$ 3.24 billion.

The audit covered verification of activities within the following subject areas:

• Competent authority and oversight
• Ante-mortem, humane handling and animal welfare controls
• Slaughter and post-mortem controls
• Processing controls
• Preventive control plans
• Microbiological controls
• Chemical residue controls

Table 1: Summary of audit scope

Competent authority/establishment visits	Number of sites visited	Locations
Opening and closing meetings	N/A	Virtual
USDA FSIS District Office	2	Atlanta, Georgia Des Moines, Iowa
AMS EV program Close face sandwich establishment	1	Sioux falls, South Dakota
Bovine slaughter and cutting establishments	2	Plainwell, Michigan Greeley, Colorado
Swine slaughter and cutting establishments	2	Sioux Falls, South Dakota, Iowa
Poultry slaughter and cutting establishments	2	Marietta, Georgia Bethlehem, Georgia
Processing establishments RTE	2	Rockmart, Georgia Fort Madison, Iowa
Cold Storage V establishments	2	Livonia, Michigan Hamtramck, Michigan

The audit process included document review, onsite observations and interviews. The CFIA auditors reviewed the administrative functions of the Food Safety Inspection Service (FSIS). This evaluation encompassed several key areas, including the regulatory and oversight frameworks, enforcement procedures, training programs, import and export controls, and official chemical residue and microbiological sampling plans and results.

2.2 Legal basis for the audit and audit standards

The CFIA audited the U.S.'s meat inspection system under the specific provisions of the Canadian food safety and animal health laws and regulations, in particular:

• Safe Food for Canadians Act and Regulations
• Health of Animals Act and Regulations
• Food and Drug Act and Regulations

CFIA conducted the audit following standard program delivery audit practices. The aim was to evaluate if CCA's inspection activities are consistent with US and Canadian regulatory and procedural requirements and specifications.

3. Competent authority and oversight

3.1 Regulatory framework

In the US, the regulatory framework comprises laws, directives, notices, and standards governing meat inspection systems and animal welfare controls. Implementation of this framework for the meat inspection system and animal welfare programs is the responsibility of both central and regional food safety and animal health authorities.

The Primary statutes governing meat production in the U.S. are the Federal Meat Inspection Act (FMIA), the Agricultural Marketing Act (AMA), the Poultry Products Inspection Act (PPIA), the Animal Welfare Act, and the Humane Methods of Slaughter Act. In addition, the U.S. also implements Title 9 of the Code of Federal Register (CFR) Chapter III Parts 300 to 590, as well as the FSIS Directives. The Acts and FSIS Directives govern the meat inspection system, hygiene and official controls of food of animal origin, import and export controls, microbiological and chemical residue controls, animal welfare, labelling, recall, and enforcement.

CFIA observed that certain audited establishments have a well-established and systemic robust animal welfare plan. However, FSIS does not mandate a documented preventive control programs in livestock and poultry slaughter facilities. Such programs could address animal welfare risks during slaughter processes, encompassing performance criteria, monitoring, deviation, and verification procedures.

There are gaps in the regulatory provisions for enforcing humane treatment of poultry in slaughterhouses.

3.2 Oversight framework

The United States Department of Agriculture (USDA) comprises 29 agencies, including FSIS. The FSIS employs approximately 9,000 employees to conduct a broad range of inspection activities. The key animal health and food safety agencies are the Animal and Plant Health Inspection Service (APHIS), the USDA Agricultural Marketing Service (AMS), and FSIS. The APHIS is responsible for protecting animal health and administers the Animal Welfare Act, which establishes animal transportation requirements.

The FSIS under the USDA is the public health regulatory agency responsible for ensuring that domestic and imported red and poultry meat and processed egg products are safe, wholesome, labelled and appropriately packaged. The inspection activities performed in the U.S. establishments are identified with the respective letter prefixes as I (import under FMAI, PPIA and EPIA), M (meat under FMIA), P (poultry under PPIA) and V (Voluntary under AMA).

The Offices of Field Operations (OFO) of FSIS supervise, manage and coordinate the regulatory and supervisory oversight and inspection of establishments that slaughter, process, import, and export red and poultry meat. The OFO is organized into 10 District Offices nationwide, supervising the establishments and FSIS personnel are located in the states under their jurisdictions. The District Managers, the Deputy District Managers and the Front-Line Supervisors (FLS) supervise the inspection tasks by the Inspection Program Personnel (IPP) in the establishments. The communication mechanism between the various management levels is in place as audited. The officials communicate via on-site visits, e-mails, virtual and in-person meetings, and phone calls.

As audited, the District Managers perform quarterly verification of the FSIS internal quality control system (QMS) and verify the completion of assigned inspection tasks by establishment via the FSIS Public Health Information Systems (PHIS). The PHIS is the IT data analytic system FSIS personnel use to collect, compile and analyse the data from inspection tasks in the meat establishments.

The FSIS's QMS also includes employee performance verification. To do so, the In-plant Performance System (IPPS) is the tool that supervisors use to assess the performance of non-supervisory in-plant inspection program personnel. A minimum of 2 IPPS assessments are conducted for each employee per fiscal year as per the FSIS Directive 4430.3. The Supervisory Tool for Assessment Results (STAR) is a tool that supervisors use to assess the knowledge and proficiency of field-level supervisory personnel (SPHVs, SCSI, and IIC) and is completed as stipulated in the FSIS Directive 4430.5.

In the establishment, the Inspector in Charge (IIC), the Consumer Safety Inspector (CSI), and Public Health Veterinarians (PHV) conduct the inspection tasks at the slaughter establishment. The IIC and CSI inspect the processing and V establishments.

AMS reviews and approves establishments as eligible suppliers for meat and meat products under USDA Export Verification (EV) Programs. The FSIS export library entry for Canada outlines specific requirements for various EV programs, including the AMS RTE Canada EV Program. This encompasses products like Ready to Eat (RTE) Closed Faced Sandwiches, with additional provisions for microbiological testing of RTE products destined for Canada.

CFIA audited one AMS close-face sandwich establishment under the EV program. This facility produces closed-face sandwiches through the FSIS voluntary reimbursable inspection service, operating under conditions outlined in 9 CFR parts 430. As per the audit findings, FSIS personnel maintain control over daily inspection during AMS processing operations, as specified in FSIS Directive 5730.1 for establishments under dual jurisdiction between FSIS and the Food and Drug Administration (FDA).

In all audited establishments, the FSIS generates and records routine verification activities in the PHIS. The priority and frequency of these verification activities depend on the expected impact on public health and risk factors calculated by a mathematical algorithm. As audited, the delivery rate of the verification tasks varies from establishment to establishment. The FSIS doesn't perform all the inspection tasks as planned, e.g. water potability and SPS tasks at the audited V establishments.

In addition, the CFIA observed areas for improvement in one or more of the 7 broader categories within the scope of this audit at the audited establishments. This highlights the need for enhanced government oversight to ensure effective enforcement of regulatory requirements and to prevent occurrences of non-compliance.

In all establishments visited under voluntary inspection, there was no mechanism to document the presence of daily shift inspection if the inspector did not perform a task during a visit.

Auditors also observed that the PHV was not always present during the entire operation at the slaughter establishment. The PHV covers multiple establishments depending on the type of activities, volume of slaughter, and location of the establishments.

3.3 Training framework

As stipulated in the FSIS Directive 4338.1 and 9 CFR part 410, training of inspection staff is mandatory for employment. The newly hired FSIS inspection personnel responsible for conducting government verification activities at establishments must complete an initial training. This training depends on the actual position and future responsibilities of the employee. The online inspector working at the slaughterhouse receives initial training covering post-mortem inspection methods and food safety overview, followed by a job shadowing period.

The Inspection Methods course covers the essential FSIS inspection verification tasks for newly promoted or newly hired CSIs and PHVs. This course includes PHIS, sanitation, Hazards Analysis and Critical Control Point (HACCP) system verification, sampling, sanitary dressing procedures, humane handling, raw, ready-to-eat (RTE), shelf-stable product hazards and preventive measures, Listeria regulations, export certification and food defence.

Continuing education for hired inspectional personnel is completed by in-class training, meetings, and an online learning management system containing FSIS-specific courses called AG Learn. AG Learn is the learning management system comprising FSIS-specific courses. All employees have access to web-based training via AG Learn.  The CFIA reviewed the FSIS training plan and employees' training records at establishments and noted no issues.

3.4 Export controls

FSIS enforces the laws and regulations for all meat products produced under FSIS inspection. FSIS certifies all meat products eligible for export, meeting FSIS and importing country requirements per FSIS Directive 13,000.5 PHIS Export Certification for meat products. FSIS updates the establishment activities in the FSIS Meat, Poultry, and Egg Product Inspection Directory. The District Offices oversee the issuance of approval and maintenance of the meat establishments for the federal grant of inspection.

The FSIS export controls verify that every meat and poultry product leaving the U.S. These export controls meet certification standards, remains free from adulteration or misbranding, and complies with the importing country's specifications.

FSIS only certifies eligible products, which are listed in the FSIS export certificate. The certificate includes the appropriate statement outlined in the FSIS Library of Export Requirements for Canada. This also applies to meat products from the AMS EV programs. Products only from approved establishments recognized as eligible in the Food Export Library for Canada or the AMS website are eligible for export to Canada.

Since February 13, 2017, FSIS issued FSIS Notice 98-16 with instructions to IPP regarding verifying compliance with HACCP, Sanitation Standard Operating Procedures (SSOPs), and 9 CFR 430 regulations in establishments that produce closed-face sandwiches (including non-traditional closed-face sandwiches, breakfast sandwiches) for export to Canada. As audited in the EV RTE establishment, the CSI performs verification tasks when products are being produced for export to Canada.

On June 13, 2022, the FSIS onboarded Canada into the PHIS, where all certificates for meat and poultry products exported from the US to Canada will be digitally signed. All the export certificates for meat and poultry products (excluding casings and egg products) exported to Canada are generated in PHIS. As audited, the Export Certificate of Wholesomeness for Meat and Poultry (FSIS Form 9060-5, 5A, 5B) generated by the PHIS export component has replaced the Certificate for Export of Meat and Poultry Products to Canada (Form 9135-3).

As observed in the 2019 CFIA audit, there is no official procedure or accompanying documents to verify the eligibility for export of products to Canada when a meat product is exported from an establishment other than a slaughter/processing establishment. During the audit, CFIA noted that when a meat product is exported from an establishment that is not the slaughter/processing establishment, there is no document from the FSIS of the slaughter/processing establishment to attest that the product conforms to Canadian requirements.

PHIS export tasks are not performed at establishments eligible for the export of products to Canada if the product is not directly exported from this facility. Therefore, the export requirements for Canada are not verified annually in all eligible establishments.

As observed at the V establishments, the FSIS inspectorate does not verify the controls related to the application of the seal, even though this information is indicated on the OMIC and endorsed by an official veterinarian.

The FSIS Meat, Poultry, and Egg Product Inspection Directory did not always reflect the activities code performed at the establishments. For example, despite the presence of the Trichinella activity code, no on-site controls were implemented at the V-establishment. Similarly, the RTE facility had an M code, but it did not undertake any procedures associated with red meat processing.

3.5 Import controls

The applicable Acts require that imported meat and poultry products originate from eligible countries and from establishments certified to export to the U.S. (21 U.S.C. 466, 620, and 1046). A country becomes eligible following an equivalence determination process completed by the FSIS in coordination with the country's CCA. Foreign establishments become eligible when the FSIS determines that a country's food safety system achieves a level of sanitary protection equivalent to the level achieved by the FSIS, and the foreign country's CCA certifies the foreign establishment as meeting U.S. requirements. The requirements that a foreign inspection system must demonstrate are provided in 9 CFR 327.2 (meat) and 381.196 (poultry).

3.6 Enforcement framework

Enforcement actions at establishments may result from the daily activities of the inspection staff or findings of audits and supervision. As per 9 CFR 500.2, the FSIS takes regulatory control actions on the 3 levels of enforcement authorities as national, district and local in case of:

• unsanitary conditions or practices
• product adulteration or misbranding
• conditions that preclude the FSIS from determining that the product is not adulterated or misbranded
• inhumane handling or slaughtering of livestock

These FSIS measures at the establishment include, but are not limited to, retaining product or rejecting equipment; refusing to allow the marks of inspection to be applied to the product; and/or suspending or withdrawing inspection or export certification and grant of inspection.

The PHIS allows inspection staff to manage inspection activities and their history. The inspection tasks and their status, non-compliance record (NR), food safety assessment (FSA), memorandum of interviews (MOI), and appeals to NR are managed through PHIS. As per FSIS Directive 5010.1, the FSIS discusses topics pertinent to an establishment's food safety system that could affect public health in weekly meetings with the establishment management. As audited, the follow-up of NR and discussions on subject matters are recorded in the weekly MOI reports.

As audited in the OFO District Offices, the FSIS demonstrates the escalating process for the repetitive outstanding non-compliances not being resolved by the operators. The OFO District office supervisors oversee the onsite food safety assessment (FSA) verifications, investigations, and analysis activities at establishments within assigned district boundaries performed by the Enforcement, Investigation, and Analysis Officers (EIAO) and the District Case Specialists. The District Office can issue administrative enforcement letters as supportable recommendations for one of the following letters: No Further Action (NFA), a Letter of Concern, Warning Letter, or Notice of Intended Enforcement (NOIE) to notify the operator to initiate corrective actions and follow-up of FSA as described in the FSIS Directive 5100.1.

3.7 Laboratory framework

The FSIS Field Service Laboratories (FSLs) support the mission of the USDA and FSIS to protect public health by performing analyses of samples collected from meat and poultry. The FSIS Office of Public Health Science (OPHS) directly oversees all three FSLs, which coordinate and perform laboratory analytical services to support FSIS farm-to-table strategies. These services encompass the disciplines of chemistry, microbiology, and pathology, focusing on food safety in meat, poultry, and egg products. The FSIS Western Laboratory, FSIS Eastern Laboratory, and FSIS Midwestern Laboratory are certified under ISO 17025 standards and follow the Microbiology Laboratory Guidebook.

The FSL receives the meat samples sent by FSIS in the establishment and analyses the sample using the U.S. accepted analytical methods. The laboratory is responsible for analysing the results and determining their compliance. The FSL enters the results into the Laboratory Information Management System (LIMS). LIMS is a reporting interface that allows the management of samples and associated data. It offers information on the sampling status and analysis results for samples submitted to FSIS laboratories.

As audited, the FSIS IPP, the district office management, and specialists have access to the LIMS to verify the compliance of the meat sampling performed at the establishments.

4. Ante-mortem, humane handling and animal welfare controls

4.1 Traceability and animal identification

The U.S. employs multiple livestock identification methods, including metal ear tags, ear notches, brands, tattoos, and radio-frequency identification. Official identification devices provide permanent livestock identification and ensure the ability to find the source of animal disease outbreaks. Removal of these devices, including devices applied to imported animals in their countries of origin, is prohibited except at the time of slaughter, as stipulated in 9 CFR 71.22. The USDA has cooperative agreements with states on the implementation of traceability. As observed at the slaughter establishments visited, bovine identification was maintained using official USDA ear tags, non-official herd, feedlot, or other identification tags or devices. Operators tattoo pigs and identify them as a lot for a day.

In the poultry slaughter establishments, the FSIS doesn't review the flock information document.

4.2 Ante-mortem inspection

The FMIA and PPIA require that government inspection personnel conduct ante-mortem inspections at slaughter establishments. The FSIS records ante-mortem verification tasks in the humane handling activities tracking system described in the FSIS Directive 6900.2. At bovine and swine slaughter establishments, FSIS completed ante-mortem inspection as per the 9 CFR 309.

The FSIS did not complete and document ante-mortem inspection in the poultry slaughter establishments prior to the start of slaughter from each truck, resulting in the slaughtering of birds from some lots without ante-mortem inspection.

4.3 Humane handling and animal welfare

Both FMIA and the Humane Methods of Livestock Slaughter Act mandate that livestock be handled and slaughtered humanely. As stipulated in 9 CFR 381.65 (b), poultry must be slaughtered in accordance with good commercial practices that will result in thorough bleeding of the carcasses and ensure that breathing has stopped prior to scalding.

The stunning methods observed during the audit include the use of electrical (electric current), chemical (carbon dioxide), or mechanical (captive bolt and gunshot) methods that are rapid, humane and effective before shackling, hoisting, and cutting the animal. The FSIS official performs the verification activities of humane handling and stunning effectiveness daily and records under the humane handling inspection activities category VIII.

The operators have developed and implemented a written animal handling program at audited slaughter establishments. The program includes the four facets of the systemic approach, including the facility design, accepted best practices, training, and the monitoring of humane handling as outlines in the FSIS directive 6900.2. Operators allow the assisted moving of non-ambulatory hogs at swine slaughter establishments and implement effective measures to prevent undue harm and suffering at the audited establishments. In bovine slaughter establishments, the cattle were not individually restrained for the captive bolt stunning.

The U.S. regulations do not require operators to have an animal welfare written program in place as per Canadian requirements SFCR article 89.1 (d).

Poultry operators are encouraged to follow Good Commercial Practices for animal welfare. As observed in both poultry slaughter establishments, return to sensibility is only checked before the scalding tanks and not during the whole stunning continuum (pre-stun shocks, stun, stun to stick, bleed and bleed out). There are no precise requirements for shackle time in poultry slaughter.

As observed in the CFIA previous audits at the swine slaughter establishments, operators allowed the assisted moving of non-ambulatory hogs with sleds or bobcats at swine slaughter establishments before the stunning.

At one of the bovine slaughter facilities, the auditors noticed that the cattle were not individually restrained for the captive bolt stunning.

5. Slaughter and post-mortem

The 9 CFR 310 and 381.76 govern the post-mortem inspection of every livestock carcass, head, and viscera as well as poultry carcass and viscera by government inspectors during and after slaughter.

5.1 Bovine (Beef)

The 9 CFR 310 governs the post-mortem inspection of each carcass and its parts. The number of inspection stations and on-line inspectors depends upon slaughter line speed. As observed during the audit, the online inspector inspects the carcasses and parts at the head/viscera and carcasses inspection stations. For a suspect animal detected at ante-mortem or during the post-mortem inspection, the official identifies the carcass, segregates the corresponding viscera and head, and rails out the carcass at the designated station for final inspection and disposition. Each slaughter establishment audited had such a station.

The offline CSI performs the daily zero-tolerance verification tasks described in the FSIS directive 6420.2 before the final wash. All bovine slaughter establishments visited also have a critical control point (CCP) after the FSIS final station.

The FSIS Directive 6100.2 describes the post-mortem inspection methods for red meat species. The FSIS directive 6410.1 describes instructions for FSIS IPP on verifying sanitary dressing and process control procedures at bovine slaughter establishments.

The World Organisation for Animal Health (WOAH) list shows that the US has a negligible Bovine spongiform encephalopathy (BSE) risk status. The 9 CFR 310.22 states the requirements for identifying, segregating, removing and disposing specified risk materials (SRM). The SRM includes the skull, brain, trigeminal ganglia, eyes, vertebral column, spinal cord, and dorsal root ganglia of cattle 30 months and older. The distal ileum of the small intestine and tonsils from all cattle are SRMs.

As observed in one of the beef establishments, the operator SRM written programs did not reflect the on-site controls regarding the identification and the segregation of the SRM for bovine over 30 months.

5.2 Swine

The U.S. implements both the traditional and New Swine Slaughter Inspection System (NSIS) for swine. As observed in the establishment operating under traditional inspection, the online FSIS IPP conducts the post-mortem inspection of 100% of carcasses as described in the FSIS Directive 6100.2. The FSIS IPP checks each carcass, head, and viscera for food safety and non-food safety defects. In NSIS and traditional inspection systems, FSIS inspectors conduct 100% post-mortem inspections at the head, viscera and carcass inspection stations. All swine slaughter establishments visited also have a CCP after that FSIS final station.

5.3 Poultry

The 9 CFR 381.76 governs the post-mortem inspection of each carcass and its parts. Furthermore, it requires all poultry slaughter establishments (other than ratites) to develop, implement, and maintain written procedures to ensure that poultry carcasses contaminated with visible fecal material do not enter the chiller. These procedures prevent contamination with enteric pathogens and feces throughout the slaughter process. The FSIS official performed the post-mortem inspection at the audited poultry slaughter establishments as per regulation 9 CFR 381. However, at one of the poultry slaughter establishments that implements the New Poultry Inspection System (NPIS), the position of the FSIS inspector at the carcass station did not allow for a thorough inspection of the carcass cavity.

6. Processing controls

6.1 Antimicrobial controls

The FDA and USDA collaboratively govern antimicrobials' use and safety to reduce microbiological contamination on the surface of carcasses, half-carcasses or quarters in slaughterhouses. The FDA evaluates the safety of antimicrobials, while the FSIS reviews information concerning the antimicrobial and determines its suitability for usage on the applicable product under FSIS jurisdiction. The FSIS directive 7120 lists safe and suitable ingredients for producing meat, poultry, and egg products. The FSIS updates the list monthly on its website. FSIS also provides a link for the complete listing of OLR and OFLR Antimicrobial Intervention Systems (PDF), the complete list of safe and suitable ingredients, and the list in 9 CFR 424.21(c) of additional acceptable food ingredients. As audited, antimicrobials (paracetic acid, lactic acid) were used as per regulatory requirements in all the establishments.

6.2 Chilling/Cooling and freezing controls

The 9 CFR 381.66 defines the poultry chilling regulatory requirements and the establishment's hazard analysis to identify the potential hazards of improper carcass chilling. Slaughter operations can use the chilling recommendation as described in the "FSIS Compliance Guideline for Minimizing the Risk of Shiga Toxin-Producing Escherichia Coli (STEC) and Salmonella in Beef (including Veal) Slaughter Operations 2017" as the support for their carcass chilling. The audited slaughter establishments implemented the chilling performance standards and FSIS recommendations. The temperature of rooms where meat products were handled, processed, packaged or labelled was appropriate to ensure the preservation of a meat product's integrity.

The operator is responsible for ensuring that all heat-processed meat and poultry products are handled and chilled to maintain the product in a wholesome and unadulterated state. Operators develop, implement and monitor a cooling schedule for every type and each lot of heat processed products.

6.3 Retained water control program

Raw, single-ingredient meat and poultry products that retain water from post-evisceration processing in excess of naturally occurring moisture are subjected to the retained water regulations. Section 9 CFR 441.10 allows for retained water in raw livestock and poultry carcasses and parts only to the extent that it is an unavoidable consequence of a process used to meet applicable food safety requirements. The amount of water retained in the product in excess of naturally occurring moisture must be prominently declared on the label. As audited, all the establishments that use a post-evisceration process that results in water retention in a raw livestock or poultry carcass or part maintain a written data-collection protocol in accordance with 9 CFR 441.10 (c)(1).

In Canada, the operators are responsible for developing and implementing retained water control programs for carcasses, parts and offal as per the Canadian requirements as prescribed in the Canadian control programs: water retention in edible raw red meat products. However, the CFIA observed that the FSIS does not perform any PHIS task to verify the implementation of the operator water retention program in poultry slaughter establishments. Moreover, the operators implement and validate water retention controls only for carcasses and parts but not for offal in the red meat slaughter establishments. Furthermore, the USDA Export Library for Canada at the processing section for retained water refers to the wrong web link for the Canadian requirements regarding the Canadian Control Programs: water retention in edible raw red meat products.

6.4 Allergen control program

On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law, declaring sesame as the 9th major food allergen recognized by the U.S. Sesame is also a priority allergen in Canada.

As per FSIS Directive 7230.1, the U.S. priority food allergens include wheat, crustacean shellfish, eggs, fish, peanuts, milk, tree nuts, and soybeans. The ingredients of public health concern that may cause food intolerance include sulphites, lactose, tartrazine, gluten, and monosodium glutamate (MSG). FSIS may request a voluntary recall when "Big 8" food allergens or other ingredients of public health concern are incorrectly declared. Canada's priority food allergens, such as sesame and mustard, are not included in the US's Big 8. As per Canada's export library requirements, descriptive terms applied to meat and poultry products must be consistent with the Canadian Food and Drug Regulations and the Safe Food for Canadian Regulations.

As audited, the FSIS directive 7230.1 is not updated with the information declaring sesame as the 9th major food allergen included in the 2021 FASTER Act. The CFIA observed deficiencies in implementing the operator's allergen control programs in the processing establishments. For example,

• At one establishment, the operator's written allergen control program did not identify mustard as an allergen. Mustard is a Canadian priority food allergen.
• At one establishment, the operator program did not define tree nuts. Pine nuts are a Canadian priority food allergen.
• At one establishment, the operator did not visually segregate and adequately identify the ingredients containing allergens. The operator's written allergen control procedure did not reflect on-site controls.

6.5 Lethality controls

The FSIS establishes performance standards for the lethality controls in RTE products as described in Appendix A of FSIS Salmonella Compliance Guidelines for Small and Very Small Meat and Poultry Establishments that Produce RTE Products (PDF). Furthermore, establishments must ensure the products are safe for consumption (i.e. free of pathogens) to produce unadulterated products and meet HACCP requirements.

For cooked products, the FSIS recommends that establishments achieve a 6.5 log or 5 log reduction of Salmonella in their process. The FSIS implements Directive 98-16 to inspect closed-face sandwiches for export to Canada. This directive provides instructions to IPP regarding verifying compliance with HACCP, SSOPs, and 9 CFR 430 regulations in establishments that produce closed-face sandwiches (including non-traditional closed-face sandwiches, e.g. breakfast sandwiches) for export to Canada.

Lethality controls were implemented per the regulatory requirements at all audited processing establishments. In the canning establishment producing shelf-stable canned meat products, the validated heat sterilisation process includes the meat products filled in sealed containers and exposed to temperatures over near of 250°F in continuous pressure cookers. As audited, an F value over 4.5 was achieved for the commercial sterility in time required to kill a known population of microorganisms in a given food under specified conditions as Clostridium botulinum—the automatic vacuum and dud detector were in place to verify the container's integrity. The audited establishment used alternative documented procedures to ensure that only safe and stable products were produced following the 9 CFR 431.10 for thermally processed and commercially sterile products. The establishment followed a validated incubation procedure when a new meat product, a new process, or corrective action to non-compliance was implemented.

7. Preventive control plans

According to part 417 of 9 CFR, every official establishment shall conduct a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures an establishment can apply to control those hazards. Part 416 of the 9 CFR states that each official establishment shall develop, implement, and maintain written SSOP's. The establishments must have self-control programs for HACCP plans and pre-requisite programs. Self-control programs must cover animal welfare, when applicable, good manufacturing practices (GMPs), SOPs and HACCP, and must be recognized by FSIS. These programs and procedures are mandatory for all animal slaughtering and processing and/or processing establishments for food of animal origin whose products are destined for export. As audited, the FSIS verifies the adequacy and effectiveness of the SSOPs and HACCP plan in the M, P and AMS V establishments described in the FSIS directive 5000.1.

The IPPs are not required to perform SSOP or HACCP verification activities listed in the Voluntary inspected establishment. As audited, establishments operating under Voluntary inspection services (except closed-faced sandwich establishments under the AMS EV RTE Program) are not required to develop and implement HACCP. The Safe Food for Canadians Regulation (SFCR) part 4 requires operators with a licence to manufacture, process, treat, preserve, grade, package, or label food must develop and implement the preventive control plans outlined in SFCR Sections 47 and 48.

The operators must maintain written sanitation SOPs for daily sanitary activities and sanitation records to be performed before and during production. The CFIA auditors conducted a pre-operational sanitation review at two audited establishments. The CFIA auditors noted that the FSIS verified the sanitation of establishments once operators or third party completed their pre-operational sanitation procedures and determined if the establishments met the sanitation standards to start operations. The FSIS verified establishments' pre-operational sanitation procedures daily as per FSIS-established procedures.

The CFIA auditors observed areas for improvement related to elements of HACCP and prerequisite programs across all audited establishments. For example, the CFIA found deficiencies in building and equipment maintenance, GMP, allergens programs and pre-op and operational sanitation programs. Two out of 3 processing establishments audited were not implementing proper labelling, storage and segregation of restricted ingredients, such as nitrates, nitrates to prevent restricted ingredients from being added to products in excess of allowable limits.

8. Microbiological controls

The Pathogen Reduction and HACCP regulations allow the bovine and swine slaughter establishments to test carcasses for generic E. coli and Salmonella as stipulated in 9 CFR 310.25. In addition, the FSIS Guideline: FSIS-GD-2019-0005, called Modernization of Swine Slaughter Inspection-Developing Microbiological Sampling Programs in Swine Slaughter Establishments, allowed very low volume establishment (<20 000 swine/year) using Traditional inspection to keep generic E. coli as indicator microorganism.

In 2019, FSIS published the final rule titled "Modernization of Swine Slaughter Inspection" 84 FR 52300, which made several changes to the regulations affect all establishments slaughtering swine, regardless of the inspection system under which they operate or the age, size, or class of swine. The final rule removed the requirement that swine slaughter establishments sample and test carcasses for generic E. coli Biotype I monitor process control. It removed the codified Salmonella pathogen reduction performance standards for hogs and replaced them with the new sampling and testing requirements. The FSIS Directive 10,250.1 allows FSIS IPP to verify the establishment of Salmonella and Campylobacter control programs for raw meat and poultry products.

The FSIS regulations approve the microbiological control program in establishments producing edible products and by-products of animal origin. FSIS develops and implements the microbiological control plan and verifies through its officials if establishments comply with the microbiological criteria and food safety levels defined in the regulations. The program is risk-based and considers data from previous years' controls. U.S.'s national microbiological control plan identifies the prevalence of pathogens relevant to public health in animal products in FSIS-inspected establishments. The plan also assesses the process controls implemented by the establishments and manages risk to preserve food safety.

The operators shall ensure that meat and poultry products produced in their establishment comply with the regulations' relevant microbiological criteria, develop risk-based sampling plans, and establish appropriate sampling frequencies. The sampling frequencies shall be comparable to those provided in the regulations. The operators establish their procedures' microbiological criteria for products and environment based on HACCP principles and good hygiene practices. The FSIS inspection staff shall verify operators' compliance with the applicable rules and criteria prescribed in regulations. In addition to verification, the FSIS also plans and conducts official microbiological sampling and testing of products and the environment.

8.1 FSIS sampling plans

The FSIS ensures that every establishment producing domestic commerce or export products is included in official government microbiological sampling and testing programs for meat and poultry. The number of samples per establishment is statistically based on the risk and production volume. The sampling activities are generated via the PHIS and performed as described in the FSIS directives. The official FSIS microbiological program currently includes the testing of:

• Salmonella and Campylobacter sampling in poultry carcasses, parts, and comminuted products.
• Zero tolerance testing program:
  • Listeria monocytogenes (Lm) in RTE meat products (RTEPROD and RTERISK)
  • E. coli O157:H7, non-O157 STECs, and Salmonella in non-intact beef (beef trimmings-bench trims-ground beef components, and raw ground beef products)
• AMS EV program for closed-faced sandwiches, including the product and environmental microbiological testing of Listeria monocytogenes and Salmonella of RTE products destined for Canada

The AMS EV program microbiological testing for closed-face sandwiches for export to Canada includes routine and intensified testing. The in-plant CSI performs routine product testing of 6 product samples per year per establishment. As audited, the intensified AMS testing is performed by the AMS QAD (Quality Assessment Division) inspector consisting of 10 food contact surfaces (FCS), 5 environmental samples, and 5 product samples once per year. The FSIS IPP reviews establishment testing data and results at least once per production week for trend analysis.

At the establishments of audited slaughter, processing, and AMS EV programs, the official inspection staff performs and records the official sampling programs and verification tasks in PHIS at the frequency as required by the AMS EV program, the FSIS programs, and Directives. The CFIA observed that the official product testing (RTEPROD RAND and RTEPROD RISK) for RTE post-lethality exposed products was completed as per the FSIS requirements. However, these 2 programs did not include routine environmental FCS testing as described in the Canadian Operational guideline: Food sample collection. In the U.S., the FCS and non-FCS testing are triggered in response to positive official verification or establishment of positive L. monocytogenes results and performed during the Intensified Verification Testing (IVT) program or a routine Food Safety Assessment (FSA) by the EIAO.

8.2 Operator sampling plans

The Pathogen Reduction/HACCP regulation allows bovine and swine slaughter establishments to test carcasses at pre-evisceration and post-chilling for generic E. coli and Salmonella as stipulated in the 9 CFR 310.25. At the time of the audit, all the slaughter establishments adequately developed and implemented the sampling frequency and pathogen reduction performance standards using the log reduction and results for generic E.coli and Salmonella and other indicatorsas APC or total count plate. Furthermore, audited beef slaughter establishments producing trimming and ground beef identified and tested the meat products for Shiga toxin-producing E. coli STEC and non-O157 STEC serogroups using the cloth sampling technique.

Under the Pathogen Reduction/HACCP Final Rule, for all poultry slaughter establishments (except for establishments that slaughter ratites), it is mandatory to develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens and fecal material throughout the entire slaughter and dressing operation. At a minimum, these procedures must include sampling and analysis for microbial organisms at the pre and post-chill points in the process to monitor process control for enteric pathogens, with some exceptions for very small and very low-volume establishments.

As described in the 9 CFR 381.65, procedures included in the HACCP plan or SSOP must collect and analyze samples for microbial organisms at the pre-chill and post-chill points in the process. As audited, microbiological testing at poultry slaughter establishments was completed per the regulatory requirements. However, FSIS did not complete the sampling for Salmonella at the pre-chilled point for poultry.

Listeria monocytogenes is a hazard that an establishment producing post-lethality exposed RTE products must control through its HACCP plan or prevent in the processing environment through an SSOP or other prerequisite program. If a product or FCS tests positive for L. monocytogenes, the product will be considered adulterated and must be reworked or destroyed. To maintain the sanitary conditions necessary to meet this requirement, establishments comply with the requirements of one of 3 Listeria alternatives listed in 9 CFR 430.4, called the "Listeria Rule." The operator's sampling program demonstrated repeated positive Listeria spp. at one audited establishment in the environment near an RTE production line. Coincidentally, the same establishment rerouted employee and visitor traffic from a raw area to the RTE area near the Listeria spp. positive sites. FSIS allowed the establishment to continue to operate without investigation.

• At one audited Ready-to-Eat (RTE) processing facility, the operator's written documentation failed to sufficiently outline the sanitation procedures for the FCS site after a sampling event.
• At one poultry slaughter establishment, the auditors observed that FSIS was not evaluating Campylobacter performance standards in raw poultry product standards.

9. Chemical residue controls

Under FMIA, PPIA, and EPIA, the FSIS is responsible for administering the National Residue Program (NRP) in meat, poultry and egg products.  As detailed in the FSIS directive 10800.4, the Office of Public Health Science (OPHS) receives, evaluates, and provides residue-related information and scientific support to the Office of Field Operations (OFO) such as Districts Offices and the Office of Policy and Program Development (OPPD) and other programs regarding chemical residue control activities. The FSIS and OPHS publish the FSIS Sampling Program and chemical residues each year to provide information on sampling of meat, poultry, and egg products for chemical contaminants of public health concern.

FSIS considers meat, poultry, and egg products to be adulterated under the authority of FMIA, PPIA and EPIA if the product contains a chemical compound that exceeds an established tolerance or action level or if the residue detected has no approved tolerance. The FDA, FSIS and the Environmental Protection Agency (EPA) developed the U.S. National Residue Program (NRP) for Meat, Poultry, and Egg Products. The FSIS administers the NRP, an inter-agency program designed to identify, rank, and analyze veterinary drugs and chemical contaminants in meat, poultry, and egg products in the 3 FSIS reference laboratories. The FDA sets tolerances for veterinary drugs, while EPA determines the limits for pesticides as included in the Title 40 of CFR.

The NRP consists of 3 separate but interrelated surveillance chemical residue testing programs: scheduled sampling (Tier 1), targeted sampling at the production or compound class level (Tier 2), and targeted sampling at the herd/flock or compound class level (Tier 2). The surveillance sampling is the scheduled sampling at the time of slaughter triggered via the notification by the PHIS system and the PHIS tasks calendar. The FSIS conducts inspector-generated sampling when they suspect that animals may have violative levels of chemical residues. The PHV performs in-plant KIS test, and samples other tissues such as kidney, liver and muscle to send for laboratory confirmatory testing should the KIS test turn positive.

As audited, the FSIS implemented NRP at all slaughter establishments. The establishment holds or controls livestock carcasses selected for testing pending the test results. For poultry carcasses, FSIS recommends that the establishment holds the specific poultry carcasses selected for residue testing pending the test results. The lot linked to the sampled carcass and parts is not held until the results are received.

When a sample result exceeds the maximum residue limit (MRL), the laboratory sends the result through the LIMS system to the establishment for the FSIS IPP and the district office follow-up. The FDA is responsible and follows up on non-compliant results at the farm to determine the root cause. The FSIS provides quarterly and annual sampling summary reports on the FSIS website. However, the FSIS NRP does not monitor the chemical residue controls for minor species such as cervidea, bison, quail, and ducks.

Imported meat products from the U.S. are subjected to routine monitoring for chemical residues in Canada. The assessed results must comply with Canadian maximum residue limits for veterinary drug residues established by Health Canada.

10. Closing meeting

The closing meeting was held virtually with representatives from the FSIS and USDA on November 30, 2023. At the meeting, the CFIA presented a summary of the preliminary findings from the audit.

11. Conclusions

Overall, the audit showed that the food safety system in the U.S. is performing as intended and demonstrates an acceptable implementation of bovine, swine, and poultry meat inspection systems in a manner equivalent to those of Canada. The audit report includes the key conclusions and provides recommendations to the U.S. based on observations made during the on-site audit.

12. Recommendations

The recommendations are linked to the specific conclusions made during this report.

CFIA recommendation 1

The CFIA requests FSIS to demonstrate a regulatory framework for animal transport and animal welfare, especially for poultry, including animal welfare preventive control plan.

FSIS action plans/comment 1

FSIS uses Directive 6900.2 Revision 3 for Humane Handling, Antemortem Inspection, and GCPs. That is our regulatory framework which outlines how the Agency will verify animal welfare in poultry. Transport is an APHIS authority.

CFIA recommendation 2

The CFIA requests that FSIS implement all the establishment's specific findings to be corrected by the operators and verified by FSIS in a timely fashion.

FSIS action plans/comment 2

FSIS provided an updated document with operator's corrective actions.

FSIS recommendation 3

The CFIA requests FSIS to

• Implement a mechanism to document daily shift inspection presence when an inspector is not scheduled to perform a task during a processing establishment visit.
• As observed during the CFIA audit in the US in 2019, the ante-mortem and post-mortem inspection at slaughter establishments is to be completed under an official.

FSIS action plans/comment 3

FSIS inspectors are instructed in FSIS Directive 5000.1 (page 26 of revision 7) to perform one Operational Sanitation Standard Operation Procedure (Sanitation SOP) verification task at each establishment in an assignment during each shift.

CFIA recommendation 4

The CFIA requests FSIS to

• Implement an official mechanism to maintain product traceability and eligibility between eligible establishments.
• Verify that PHIS export tasks are to be performed at the establishment eligible for import to Canada when the product is not directly exported from this facility.
• Implement a mechanism to update the FSIS Meat, Poultry, and Egg Product Inspection Directory to reflect the current activities performed in the establishments exporting to Canada.

FSIS action plans/comment 4

• There are some product traceability requirements in place including ground beef grinding records, shipping and receiving records and coding of thermally processed products, but there are no complete product traceability requirements for the entire gamut of FSIS inspected products.  Having said that, many establishments maintain extensive records that help them with traceability of products moving into commerce as well as components used in product formulations.
• Export certification occurs at the establishment that is exporting the product.
• FSIS updated the MPI directory earlier this year along with the establishment demographic data file.  For the directory, FSIS added some demographic variables including lot/long data and for the demographic data file, we expanded species, classes and product information. These updates were made earlier this year and a Constituent Update went out regarding the updates.

CFIA recommendation 5

The CFIA requested that FSIS implement procedures to ensure that ante-mortem poultry inspection from each lot is completed within 24 hours before the slaughter.

FSIS action plans/comment 5

9 CFR 381.70(a) (PDF) requires antemortem to be made on the day of slaughter in any official establishment. Instructions to FSIS personnel in FSIS Directive 6100.3.

CFIA recommendation 6

The CFIA request that FSIS:

• All slaughter establishments exporting to Canada are directed to include in their Preventive Control Plan (PCP) the written animal welfare program and the description and monitoring of controls to prevent animal suffering as per the Canadian requirements stipulated in the Canadian SFCR 89.1 (d).
• the competent authority should establish specific shackle time in poultry slaughter.

FSIS action plans/comment 6

• Based on FSIS regulation, the establishment is not required to have a written plan. The systematic approach is a written plan that would typically include these items. The systematic plan becomes "robust" when the establishment voluntarily submits it to FSIS for review and designation as a robust systematic approach (RSA).  FSIS will work with CFIA to address PCP in the export library.
• FSIS does not set specific shackle times for poultry. If shackle time is a part of the systematic approach in the establishment's written plan, then FSIS as an agency would verify what is in their plan. FSIS does look at the ante-mortem processing of birds. This would include humane handling of the birds, GCPs. We are looking at what is happening along the continuum of the process from unloading to scalding.

CFIA recommendation 7

The CFIA requests

• that the red meat establishments implement water retention controls for the offal as specified in the Canadian Control Programs: water retention in edible raw red meat products.
• that FSIS to update the USDA Export library for Canada at the processing section for retained water to include the right web link for the Canadian requirements at Canadian Control Programs: water retention in edible raw red meat products.

FSIS action plans/comment 7

• 9 CFR 441.10 addresses water retention in carcasses and parts and includes offal. Excepts below should help clarify requirements when processing results in water retention.
  1. Raw livestock, poultry, and fish carcasses and parts will not be permitted to retain water resulting from post-evisceration processing unless the establishment preparing those carcasses and parts demonstrates to FSIS, with data collected in accordance with a written protocol, that any water retained in the carcasses or parts is an unavoidable consequence of the process used to meet applicable food safety requirements.
  2. Raw livestock, poultry, and fish carcasses and parts that retain water from post-evisceration processing and that are sold, transported, offered for sale or transportation, or received for transportation, in commerce, must bear a statement on the label in prominent letters and contiguous to the product name or elsewhere on the principal display panel of the label stating the maximum percentage of water that may be retained (e.g., "up to X% retained water," "less than X% retained water," "up to X% water added from processing"). The percent water statement need not accompany the product name on other parts of the label. Raw livestock and poultry carcasses and parts that retain no water may bear a statement that no water is retained.
• FSIS will update the correct link in the export library through collaboration with CFIA

CFIA recommendation 8

The CFIA requests that FSIS update the FSIS Directive 7230.1 to include sesame as a food allergen.

The CFIA requests operators to implement and regularly update the list of allergens and restricted ingredients and verified by FSIS.

FSIS action plans/comment 8

The FSIS Directive 7230.1, Ongoing Verification of Product Formulation and Labeling targeting the None Most Common ("Big 9") Food Allergens, was revised and issued on January 16, 2024.

CFIA recommendation 9

The CFIA requests FSIS that the establishments implement preventive control plans at all establishments under Voluntary inspection involved in manufacturing, processing, treating, preserving, grading, packaging or labelling food.

FSIS action plans/comment 9

As per directive FSIS Directive 12600.1:

The FSIS requires all facilities where it provides voluntary or other reimbursable services to:

1. Maintain sanitary conditions (e.g., 9 CFR 416.1-416.5)
2. Meet any other regulatory requirements applicable to the products involved (e.g., temperature requirements for rabbits) or services requested
3. Apply the Federal mark of inspection to products only when voluntary or other reimbursable inspection services are provided; and
4. Remain current on payments to FSIS.

CFIA recommendation 10

The CFIA requests FSIS to provide information regarding the responsibilities, the monitoring and the sampling results of the chemical residues for minor species such as duck, quail, cervids and bison.

FSIS action plans/comment 10

According to the Poultry Products Inspection Act (PPIA), domestically raised chickens, turkeys, ducks, geese, guineas, ratites, and squabs are amenable to the PPIA and are therefore subject to mandatory inspection. FSIS provides voluntary inspection of any migratory waterfowl or game bird (including quail) (FSIS Directive 12600.1). Other "exotic species" including reindeer, elk, deer (any farm-raised species of the family Cervidae), antelope, water buffalo, bison, buffalo, or yak are eligible for voluntary inspection under 9 CFR part 352 (PDF). The National Residue Program does not normally monitor or test these minor species, but inspectors can conduct Kidney Inhibition Swab (KISTM) tests on carcasses that they suspect may contain violative levels of one or more chemical residues (FSIS Directive 10800.1 (PDF)). In the past 5 fiscal years, we have had no positive results in any of the minor species listed above (8 bison, 1 yak, 1 deer/reindeer – all negative in-plant KISTM results).