Final report of an audit conducted in the United States of America to evaluate meat inspection systems governing the production of meat and meat products intended for export to Canada – September 9 to 27, 2019

On this page

• Abbreviations and special terms used in the report
• Executive summary
• 1. Introduction
  • 1.1 Audit objective, scope, and methodology
  • 1.2 Legal basis for the audit and audit standards
• 2. Competent authority and oversight
  • 2.1 Regulatory framework
  • 2.2 Oversight framework
  • 2.3 Training framework
  • 2.4 Export controls
  • 2.5 Import controls
  • 2.6 Enforcement framework
  • 2.7 Laboratory framework
• 3. Ante-mortem, humane handling and animal welfare controls
  • 3.1 Animal identification
  • 3.2 Ante-mortem inspection and Humane handling controls
  • 3.3 Humane handling and animal welfare
• 4. Slaughter and post-mortem
  • 4.1 Bovine (beef and bison)
  • 4.2 Swine
  • 4.3 Poultry
  • 4.4 Ovine
• 5. Processing controls
  • 5.1 Antimicrobial controls
  • 5.2 Chilling/Cooling and freezing controls
  • 5.3 Retained water control program
  • 5.4 Allergens control program
  • 5.5 Lethality treatment
• 6. Preventive control plans
• 7. Microbiological controls
  • 7.1 FSIS sampling plans
  • 7.2 Operator sampling plans
• 8. Chemical residue controls
• 9. Closing meeting
• 10. Conclusions
• 11. Recommendations

Abbreviations and special terms used in the report

AALA

American association for laboratory accreditation

AMS

Agricultural Marketing Service

APHIS

Animal and Plant Health Inspection Service

CBP

Customs and Border Protection

CCA

Central Competent Authority

CFIA

Canadian Food Inspection Agency

CFR

Code of Federal Regulations

CCP

Critical control point

CSI

Consumer safety inspector

EIAO

Enforcement investigations and analysis officer

EPA

Environmental Protection Agency

EV

Export verification

FCS

Food contact surface

FDA

Food and Drug Administration

FLS

Front line supervisor

FMIA

Federal Meat Inspection Act

FSA

Food safety assessment

FSIS

Food Safety Inspection Service

HACCP

Hazard Analysis and Critical Control Points

HATS

Humane handling activities tracking system

HIMP

HACCP Based Inspection Model Project

IIC

Inspector in charge

IPP

Inspection program personnel

IPPS

In-plant Performance System

IVT

Intensified verification testing

Lm

Listeria monocytogenes

MOI

Memorandum of interview

MRLs

Maximum residues limits

NR

Non-compliance record

NRP

National Residue Program

NSIS

New Swine Inspection System

NSL

National science laboratories

WOAH

World Organization for Animal Health

OFO

Office of field operation

PHV

Public health veterinarian

PPIA

Poultry Products Inspection Act

PHIS

Public Health Information System

POE

Port of entry

QAD

Quality Assessment Division

QSA

Quality System Assessment Program

RFI

Radio frequency identification

RTE

Ready to eat

SAT

Surveillance advisory team

SCSI

Supervisory consumer safety inspectors

SRM

Specific risk material

SOP

Standard operating procedures

SPHV

Supervisory Public Health Veterinarians

SSOP

Sanitation standard operating procedures

STAR

Supervisory tool for assessment results

U.S.

United States

USDA

United States Department of Agriculture

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 (USA, hereafter referred to as U.S.) intended for export to Canada. The Canadian Food Inspection Agency (CFIA) conducted the audit during the period of September 9 to September 27, 2019. The main objective of the audit was to verify if the U.S. is implementing a meat inspection system equivalent to that of Canada, and if that system is capable of producing safe, unadulterated, and properly labelled meat products for export to Canada. The audit focussed on 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

Overall, the audit showed that meat inspection system governing the production of meat and meat products in the U.S. is performing as intended in an adequate manner and generally demonstrate an acceptable implementation in a manner to be equivalent to that of Canada. The audit report includes the conclusions and recommendations for the U.S. to address the deficiencies identified during the audit.

1. Introduction

1.1 Audit objective, scope, and methodology

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 residues controls

The CFIA auditors reviewed administrative functions at the Central Competent Authority (CCA) headquarters and district offices. The auditors evaluated:

• regulatory framework
• oversight framework
• enforcement framework
• training framework
• export and import framework

The representatives from the CCA accompanied the auditors throughout the audit. The audit process included document review, onsite observation and interviews.

1.2 Legal basis for the audit and audit standards

The CFIA conducted the audit under specific provisions of the Canadian laws and regulations, in particular:

• Safe Food for Canadians Act and regulations
• Health of Animals Act and regulations

Table 1: Summary of audit scope

Competent authority/establishment visits	Number of sites visited	Location
Opening and closing meetings	N/A	Washington, DC
United States Department of Agriculture (USDA) Agricultural Marketing services (AMS) Office and laboratory	1	Gastonia, NC
USDA Food Safety Inspection Service (FSIS) District Office	1	Raleigh, NC
Slaughter AMS Export verification (EV) program establishments Bison and Ovine	2	Cannon Falls, MN Dixon, CA
Processing establishments including AMS EV program	5	Sheboygan Falls, WI Mc Cook, IL GrovePort, OH Claremont, NC
Bovine slaughter establishments	2	Green Bay, WI Fresno, CA
Swine slaughter establishments	2	Austin, MN Tar Heel, NC
Poultry slaughter establishments	2	Summit, MS Lewiston Woodville, NC
Storage establishment	1	Underwood, IA

The audit was conducted in a manner consistent with conventional program delivery audit standards, and was intended to assess the degree to which inspection activities performed by the CCA were consistent with the regulatory and procedural requirements and specifications.

2. Competent authority and oversight

2.1 Regulatory framework

The primary statutes governing the meat production in the U.S. are the Federal Meat Inspection Act (FMIA), Agricultural Marketing Act (AMA), Poultry Products Inspection Act (PPIA), the Animal Welfare Act, 9 Code of Federal Regulations (CFR) chapters 300 to 590, and FSIS directives. The acts and FSIS directives govern:

• meat inspection system
• hygiene and official controls of food of animal origin
• import and export controls
• microbiological and chemical residues controls
• animal transportation and welfare
• labelling
• recall
• animal identification and traceability
• sanctions

2.2 Oversight framework

The United States Department of Agriculture (USDA) consists of 29 agencies and offices with nearly 100,000 employees. The key agencies related to animal health and food safety are Animal and the Plant Health Inspection Service (APHIS), USDA Agricultural Marketing Service (AMS) and FSIS. The APHIS is responsible for protecting animal health, animal welfare, and plant health.

The FSIS is the public health regulatory agency responsible for ensuring that domestic and imported meat, poultry, and processed egg products are safe, wholesome, and correctly labelled and packaged. The inspection activities performed in the U.S. establishments are identified with the respective letter prefixes as

• I (import under FMIA, PPIA and EPIA)
• M (meat under FMIA)
• P (poultry under PPIA)
• V (Voluntary under AMA)

The U.S. is divided into 10 FSIS district areas with a variable number of states to supervise. The 10 FSIS district offices (Office of Field Operations - OFO) manage regulatory oversight and inspection of establishments that slaughter, process, import and export meat, poultry and egg products and manage the supervisory oversight of inspection staff. The district managers supervise the front-fine supervisors (FLS). The FLS supervise the supervisory public health veterinarians (SPHV) and the supervisory consumer safety inspectors (SCSI) that overview the work of the inspection personnel in the establishments. As audited, the communication between the various management levels is completed via on-site visits, internet and phone calls.

The inspection personnel such as inspection program personnel (IPP), consumer safety inspector (CSI) and public health veterinarians (PHV) conduct the inspection tasks at the slaughter establishment. The Inspector in charge (IIC) performs inspection at the processing and V establishments. The regulation 9 CFR article 307.4 requires inspection to be conducted under the supervision of a FSIS employee, therefore a government inspector conducts verification activities at least once per shift, during meat and poultry processing operations. FSIS identifies a "shift" as 8 consecutive hours. In all processing establishments visited, there was no mechanism to document daily shift inspection presence if the inspector does not perform a task during a visit at the establishment.

The AMS reviews and approves establishments as eligible suppliers of meat and meat products under the USDA Export Verification (EV) Programs. The FSIS export library entry for Canada currently identifies the following EV programs for products exported to Canada with specific requirements:

• meat and meat products derived from bison or buffalo
• meat, meat products, and natural casings derived from ovine and caprine animals slaughtered in the U.S. that are less than 12 months of age
• ready to eat (RTE) closed faced sandwiches produced under the AMS RTE Canada EV program including microbiological testing of RTE products destined for Canada

The AMS EV program approval and eligibility is maintained through a bi-annual audit performed by the AMS auditors who verify the implementation of the approved USDA Quality System Assessment (QSA) Program.

The bison and ovine/caprine are slaughtered under the EV programs that outline the specified product requirements for Canada. The voluntary establishments operating under the AMS RTE closed-face sandwich EV program are operating under 9 CFR part 430 for the control of Listeria monocytogenes in post-lethality exposed RTE products. The daily inspection at the EV program slaughterhouses and the processing operations for RTE remain under the responsibility of the FSIS personnel as stipulated in the FSIS directive 5730.1 for establishment under dual jurisdiction between FSIS and Food and Drug Administration (FDA).

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 and SCSI) and is completed as stipulated in the FSIS directive 4430.5.

The CFIA audited 1 bison and 1 ovine AMS EV program establishments. At the ovine slaughter establishment, there is a continuous presence of the PHV and IPP as ovine is an amenable species.

At the bison slaughter establishment, ante-mortem and post-mortem inspection is completed by the FSIS IPP without the continuous physical presence of the PHV. The PHV is only present when a veterinary post-mortem judgment is necessary on a segregated suspect carcass. AMS auditor visits twice per year to verify the implementation of the EV program in the slaughter establishments as stipulated in the Quality Assessment Division (QAD) 1031 procedure EV program for ovine and caprine and the QAD 1030C EV program for bison (buffalo)-Canada and the EU.

As audited, the FSIS routine verification activities at all establishments are generated and recorded in the web-based Public Health Information System (PHIS). The priority and frequency for these verification activities is based 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. At 13 of the 14 establishments visited, the CFIA noted deficiencies related to 1 or more of the 7 broader areas within the scope of this audit, thereby reflecting that government oversight was not fully adequate to enforce the regulatory requirements and prevent the occurrence of non-compliance.

2.3 Training framework

As stipulated in the FSIS directive 4338.1 and 5 CFR part 410, training is a condition of employment. The newly hired FSIS inspection personnel responsible to conduct government verification activities at establishments attend an initial training. This training depends on the actual position and future responsibilities of the employee. The online inspector working at the slaughterhouse receives an initial training covering post-mortem inspection methods and food safety overview followed by in-plant 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 the training:

• PHIS
• sanitation
• Hazard Analysis Critical Control Point (HACCP)
• verification
• sampling
• sanitary dressing procedures
• humane handling
• dangers and preventives controls related to raw meat
• RTE shelf stable product hazards and preventive measures
• the Listeria regulations
• export certification
• food defense

Continuing education for hired inspectional personnel is completed by in-class training, meetings and through an online learning management system containing FSIS specific courses called AgLearn. AgLearn is the learning management system containing FSIS specific courses and all employees have access to web-based training via AgLearn.

AMS auditors also receive a primary livestock on-farm auditing course related to antibiotics, growth promotion administration, feeding regime, source/age verification, sustainability, and animal welfare. AMS auditors are trained to conduct audits at farms and processing establishments operating under an approved AMS EV programs. The CFIA reviewed the FSIS and AMS personnel training records at establishments and no issue was noted.

2.4 Export controls

FSIS ensures that all meat and poultry products exported from the U.S. are certified, and not adulterated or misbranded. To do so, the FSIS enforces the same laws and regulations for all products produced under FSIS inspection, and certifies all products eligible for export as meeting both FSIS and importing country requirements as per FSIS Directive 9000.1 Rev. 2, Export Certification.

Only eligible products are issued a FSIS export certificate which includes the applicable statement as available in the FSIS library of Export Requirements for Canada including the meat products from the AMS EV programs. Only products from establishments listed as eligible on the AMS website may be exported. AMS requires that the establishments have approved products lists (for each country) in order for FSIS to approve and sign the export certificate. Since February 13, 2017, FSIS released 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, such as breakfast sandwiches) for export to Canada. In these EV RTE establishments, the in-plant inspection personnel perform verification when products are being produced for export to Canada.

The CFIA noticed that there is no official procedure or accompanying document to verify the eligibility for export to Canada when a meat product is exported from an establishment other than slaughter/processing establishment. During the audit CFIA noted that when a meat product is to be exported from an establishment that is not the slaughter/processing establishment, there is no document from the operator or FSIS of the slaughter/processing establishment to attest that the product conforms to the Canadian requirements. One establishment visited was associated with a port of entry (POE) violation and their products were transferred to a storage establishment. At the storage establishment, there was no document from the establishment of origin or FSIS attesting that the poultry meat product was meeting the Canadian requirements.

During the audit at the AMS EV program establishment handling eligible and ineligible meat products, the operator had not developed or implemented a written segregation program. Furthermore, the inspector in charge (IIC) didn't perform any task to verify the segregation of eligible and ineligible products.

2.5 Import controls

The applicable acts require that imported meat and poultry products originate from eligible countries and from establishments that are 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 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), 381.196 (poultry).

Prior to being presented to the FSIS for re-inspection, importers into the U.S. must file a customs entry form with the appropriate U.S. Customs and Border Protection (CBP) port director and are subject to inspection at the POE by CBP officer. The CBP officer verifies that the imported products are permitted entry into the U.S., are represented by the proper paperwork, and comply with USDA Animal and Plant Health Inspection Service (APHIS) regulations. No official import establishment where FSIS perform import inspection under FMIA and PPIA was visited during this audit.

2.6 Enforcement framework

As stipulated in the 9 CFR 500.2, the FSIS may take regulatory control action in case of:

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

These 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. The PHIS is the tool that allows inspection staff to manage inspection activities and their history. The inspection tasks and their status, non-compliance record (NR), food safety assessment, memorandum of interviews (MOI), appeals to NR, are managed through PHIS. As described in the FSIS directive 5010.1, the IPP discuss topics that are pertinent to an establishment's food safety system and that could affect public health in weekly meeting with the establishment management.

As audited, port of entry (POE) violation follow-up procedures were not followed as per FSIS directive 9040.5. For example no MOI was completed by the IIC to verify if the proposed corrective actions were adequate. Weekly meetings were not always performed and documented in a MOI at 4 audited establishments. 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 the IPP documents non-compliance, the establishment must comply with regulatory requirements by correcting the noncompliance. In order to close a NR, the inspector must verify onsite if the non-compliance is addressed in a satisfactory manner. At all audited establishments, the NRs were closed without written documentation to demonstrate that FSIS conducted inspection activities to verify that the establishment had met the requirements of 9 CFR 416.15 and 417.3.

2.7 Laboratory framework

FSIS have 3 field services laboratories that coordinate and conduct laboratory analytical services in support of the FSIS' farm-to-table strategies in the disciplines of chemistry, microbiology, and pathology for food safety in meat, poultry, and egg products.

The USDA AMS has a National Science Laboratories (NSL) located in Gastonia, NC, and Blakely, GA. Those laboratories offers a wide range of analytical testing services on a fee-for-service basis. The NSL is accredited by the American Association for Laboratory Accreditation (AALA). Accreditation is valid for 2 years. In addition to the annual AALA audit, AMS auditors also conduct internal audits. In the laboratory visited during this audit, management and technical requirements were assessed. Management requirements included organization, quality management, document controls, control of non-conforming testing, and internal audit. Technical requirements included:

• personnel
• accommodation and environmental conditions
• test methods and methods validation
• equipment
• material used in testing
• handling of test items
• quality of test methods
• reporting of results

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

3.1 Traceability and animal identification

Multiple methods of animal identification of livestock are employed in the U.S. including metal ear tags, ear notches, brands, tattoos and radio-frequency identification (RFI). Official identification devices are intended to provide permanent identification of livestock and to 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 the 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 or feedlot or other identification tags or devices. Tattoos were used for identifying pigs. Birds were identified using the flock information document.

3.2 Ante-mortem inspection

The FMIA and PPIA require that government inspection personnel conduct ante-mortem inspection at slaughter establishments. The ante-mortem and humane handling FSIS verification tasks are recorded in the humane handling activities tracking system (HATS) as described in the FSIS directive 6900.2. At bovine, swine, ovine and bison establishments, ante-mortem inspection was completed as per the 9 CFR 309. At poultry slaughter establishments, ante-mortem inspection was not completed and documented prior to the start of slaughter from each farm, thereby resulting in slaughtering of birds from some farms without ante-mortem inspection.

3.3 Humane handling and animal welfare

According to FSIS Directive 6900.2, if livestock arriving on a transport vehicle appear exhausted or dehydrated, IPP are to ask establishment management whether the truck driver stopped within the preceding 28 hours (28-hours law) to provide the animals rest, food, and water. If the truck driver or establishment is unwilling to provide the information, or if IPP believe the condition of the animals could be the result of being deprived of rest, food, and water for over 28 hours, IPP are to contact APHIS, area veterinarian-in-charge, via their FSIS chain of command, so that APHIS can conduct an investigation.

The FMIA and the Humane Methods of Livestock Slaughter Act both mandate that the handling and slaughter of livestock be carried out by humane methods. As stipulated in the 9 CFR article 381.65 (b), poultry be slaughtered in accordance with good commercial practices in a manner that will result in thorough bleeding of the carcasses and ensure that breathing has stopped prior to scalding. Audited slaughter establishments developed and implemented a written animal handling program. The program includes the 4 aspects of the systemic approach including the design of the facilities, accepted best practices, training and the monitoring of humane handling as described in the FSIS directive 6900.2. At audited ovine slaughter establishment, a protruding metal rail was observed at the live receiving area with a potential to injure animals. Assisted moving of non-ambulatory hogs was allowed at swine slaughter establishment, however effective measures were taken to prevent undue harm and suffering at the audited establishments.

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 and effective, prior to shackling, hoisting, and cutting the animal. The official humane handling verification activities of the stunning effectiveness is performed daily by FSIS personnel and recorded under the HATS category VIII.

4. Slaughter and post-mortem controls

4.1 Bovine (beef and bison)

Post-mortem inspection of each and every livestock carcass, head, and viscera and poultry carcass and viscera by government inspectors during and after slaughter is required as per 9 CFR 310 and 381.76.

9 CFR article 310 requires that post-mortem inspection be conducted on each carcass and its parts. The number of inspection stations and on-line inspectors depend upon slaughter line speed. As observed during the audit, the carcasses and parts are inspected first by the online IPP at the head/viscera and carcasses inspection stations. All U.S. retained suspect carcasses and parts segregated at the ante-mortem and/or post-mortem inspection stations are adequately identified and railed out for the complete post-mortem examination and disposition. The zero tolerance verification tasks for the contamination is performed daily by the off line CSI as described in the FSIS directive 6420.2 before the final wash. All bovine and bison slaughter establishment visited also has a critical control point (CCP) at that station.

The post-mortem inspection methods for red meat species for livestock are described in FSIS Directive 6100.2. Instructions to FSIS IPP on how to verify sanitary dressing and process control procedures at bovine slaughter establishments are included in FSIS directive 6410.1. The FSIS IPP conducts post-mortem inspection of exotic animals (bison or buffalo) as per 9 CFR Part 310 and 352. Post-mortem inspection is conducted according to FSIS Directive 6100.2.

As per the World Organisation for Animal Health (WOAH; founded as Office International des Épizooties (OIE)) list, U.S. have a negligible bovine spongiform encephalopathy (BSE) risk status. The 9 CFR 310.22 state the requirements for the identification, segregation, removal and disposition of specified risk materials (SRM). The SRM include:

• skull
• brain
• trigeminal ganglia
• eyes
• vertebral column
• spinal cord
• dorsal root ganglia of cattle 30 months of age and older

The distal ileum of the small intestine and tonsils from all cattle are SRMs. At bison slaughter establishment visited, FSIS is not required to perform the daily SRM tasks. However, the FSIS veterinarian was conducting the task but not recording it. The SRM controls were verified only by the AMS auditor during the biannual audit and not by the FSIS during the daily bison slaughter operation by FSIS. The CFIA observed a non-dedicated SRM tool being used during the removal of the spinal cord during the evisceration process at this establishment.

At one of the beef slaughter establishments audited, the auditors noted the presence of more than 2 cm aorta on harvested hearts.

4.2 Swine

Swine post-mortem inspection includes traditional, HACCP based Inspection Model Project (HIMP) and New Swine Slaughter Inspection System (NSIS). As observed in the establishment operating under traditional inspection, the online FSIS IPP conducts 100% of the post-mortem inspection activities 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 HIMP and NSIS inspection system, sorting activities shifted from FSIS inspectors to establishment personnel and FSIS inspectors still conduct 100% post-mortem inspection at the head, viscera and carcass inspection station.

4.3 Poultry

The 9 CFR 381.76 regulations require that post-mortem inspection be conducted on each carcass and its parts. Furthermore, it requires that all establishments that slaughter poultry (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 and to prevent contamination with enteric pathogens and feces throughout the slaughter process. The post mortem is performed as required by regulation 9 CFR 381 at the audited poultry slaughter establishments.

4.4 Ovine

9 CFR 310 requires that post-mortem inspection be conducted on each carcass and its parts. The number of inspection stations and on-line inspectors depend upon slaughter line speed. As observed during the audit, the carcasses and parts are inspected by the online IPP at the head/viscera and carcasses inspection stations. Furthermore, ovine meat exported to Canada must meet EV Program requirements.The AMS EV program verifies that suppliers meet the specified product requirements for Canada under the EV program through an approved USDA QSA Program. They also verify that ovine and ovine products meet the following requirements:

• animals are traceable to live production records which indicate they are less than 12 months of age at the time of harvest or
• carcasses do not exhibit the dental characteristics of the eruption of a permanent incisor through the gum, as determined during the harvest process

At audited ovine slaughter establishment, the EV program requirements were verified only by the AMS auditor during the biannual audit and not by FSIS during the daily ovine slaughter operation.

5. Processing controls

5.1 Antimicrobial controls

The use and safety of new and current antimicrobials are jointly reviewed and determined by the FDA and USDA. The FDA determines whether the antimicrobial is safe. Once the FDA makes that determination, FSIS reviews information concerning the antimicrobial and determines its suitability for usage on the applicable product under FSIS jurisdiction. The list of safe and suitable ingredients used in the production of meat, poultry and egg products are available in the FSIS directive 7120.1, which is updated monthly and available on the FSIS website. As audited, antimicrobials were used as per regulatory requirements in all the establishments.

5.2 Chilling/cooling and freezing controls

The poultry chilling regulatory requirements are stipulated in the 9 CFR 381.66. Furthermore, establishment's hazard analysis is required to identify the potential hazards associated with improper carcass chilling. Slaughter operations can use the chilling recommendation 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 chilling performance standards and FSIS recommendations were being met at the audited slaughter establishments. The temperature in the rooms where meat products were processed, packaged, labelled or handled were appropriate to ensure the preservation of a meat product.

The operator is responsible for ensuring that all heat processed meat and poultry products are handled and chilled so that the product is maintained in a wholesome and unadulterated state. A cooling schedule must be developed and filed for every type of heat processed product. The chilling process must be monitored to demonstrate that each lot complies with the validated established cooling schedules. At the audited processing establishments, the CFIA noticed some deficiencies related to preventive control measures of cooling cooked product. For example, in 1 establishment the chilling and freezer CCP did not include the time component for meat product to attain 40°F as required by "Appendix B Compliance Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization)".

5.3 Retained water control program

Raw, single-ingredient meat and poultry products that retain water as the result of post-evisceration processing in excess of naturally occurring moisture, are subject 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 which 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) except the bison slaughter establishment which did not implement a written retained water control program.

5.4 Allergen control program

As described in the FSIS directive 7230.1, the U.S. priority food allergens include:

• wheat
• crustacean shellfish
• eggs
• fish
• peanuts
• milk
• tree nuts
• soybeans

The ingredients of public health concern that may cause food intolerance include sulfites, 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 not properly declared. Canada's priority food allergens such as sesame and mustard are not included in U.S. 's Big 8. As per the export library requirements for Canada, descriptive terms applied to meat and poultry product must be consistent with the Canadian Food and Drug Regulations and the Safe Food for Canadian Regulations.

The CFIA observed deficiencies related to the implementation of allergen control program. At one audited establishment, operator's written allergen control program didn't identify all Canadian priority food allergens. Furthermore, allergens were not properly labelled to identify each specific allergen present in the ingredients.

5.5 Lethality controls

The FSIS has established 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". Furthermore, establishments must ensure the products are safe for consumption (in other words, are free of pathogens) to produce unadulterated product and meet HACCP requirements. For cooked products, FSIS recommends that establishments achieve a 6.5 log or 5 log reductions of Salmonella in their process. The FSIS implemented the directive 98-16 for the inspection of closed face sandwiches for export to Canada. This notice 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, such as, breakfast sandwiches) for export to Canada. Lethality controls were implemented as per the regulatory requirements at all audited processing establishments.

6. Preventive control plans

According to 9 CFR, article 417, 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. In part 416, the 9 CFR states that each official establishment shall develop, implement, and maintain written SSOP's. As audited, the FSIS verify the adequacy and effectiveness of the SSOPs and HACCP plan as described in the FSIS directive 5000.1.

As stated in 9 CFR Part 352, the inspection of exotic animal products (such as bison) is conducted under the applicable provisions of the Agricultural Marketing Act (AMA) of 1946, as amended. The regulation 9 CFR Part 352 does not reference 9 CFR Part 417, which sets out the requirement for HACCP plans. However, it requires that official bison establishments comply with the provisions of sanitation as per 9 CFR 416.1-416.6. The IPP are not required to perform SSOP or HACCP verification activities listed in Directive 5000.1 in these establishments. As audited, bison slaughter and establishments operating under voluntary inspection services (except closed faced sandwiches establishments under AMS EV RTE Program) are not required to develop and implement HACCP. The Safe Food for Canadians Regulation (SFCR) part 4 requires that operators who hold a licence to manufacture, process, treat, preserve, grade, package or label food must develop and implement the preventive control plans as outlined in the CFIA Regulatory requirements: Preventive controls.

The CFIA auditors noted various deficiencies related to elements of HACCP and prerequisite programs (SPS and SSOPs) at 13 out of 14 audited establishments.

7. Microbiological controls

7.1 FSIS sampling plans

The FSIS ensures that every establishment producing products for domestic commerce or for export 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, part 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 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 routine product testing is performed by the in-plant CSI consisting of 6 product samples per year per establishment. The intensified AMS testing is performed by the AMS QAD inspector consisting of 10 food contact surface (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 bovine and ovine slaughter establishments, FSIS records did not demonstrate that the inspector verified the effectiveness of the operator's corrective actions in response to the positive E. coli O157:H7 and generic E. coli samples, respectively.

At the audited slaughter, processing and AMS EV program establishments, the official sampling programs and verification tasks are generally performed and recorded 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 for RTE^Footnote 1 post-lethality exposed product was completed as per the FSIS requirements. However, these 2 programs didn't include routine environmental FCS testing as described in the Canadian National Microbiological Monitoring Program Sampling Guidelines & Assessment Criteria for Red Meat and Poultry. In the U.S., the FCS and non-FCS testing are triggered in response to positive official verification or establishment positive Lm results and performed during the Intensified Verification Testing (IVT) program or during a routine Food Safety Assessment (FSA) by the enforcement investigations and analysis officer (EIAO).

7.2 Operator sampling plans

Under the Pathogen Reduction/HACCP regulation, bovine and swine slaughter establishments are required to test carcasses for generic E. coli and Salmonella as stipulated in the 9 CFR 310.25. At the time of the audit, all the slaughter establishments were adequately applying the sampling frequency and pathogen reduction performance standards for generic E.coli and Salmonella. Furthermore, audited beef slaughter establishments producing trimming and ground beef, identify and test the meat products for Shiga toxin-producing Escherichia coli (STEC) E. coli O157H7 and non- E. coli O157H7 STEC.

All poultry slaughter establishments, except for establishments that slaughter ratites, are required 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. 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. Microbiological testing at poultry slaughter establishments was completed as per the regulatory requirements.

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 a SSOP or other prerequisite program. If a product or FCS tests positive for Lm, the product will be considered adulterated and must be reworked or destroyed. In order to maintain the sanitary conditions necessary to meet this requirement, establishments comply with the requirements of 1 of the 3 Listeria alternatives listed in 9 CFR 430.4, called the "Listeria Rule". At one audited establishment, the operators sampling program demonstrated repeated positive Listeria spp. results in the environment near a RTE production line. Coincidentally, the same establishment had rerouted employee and visitor traffic from a raw area to the RTE area, near the Listeria spp positive sites. The establishment had been allowed to continue to operate without FSIS investigation.

8. Chemical residue controls

FSIS considers meat, poultry, and egg products to be adulterated under the FMIA, PPIA and EPIA if the product contains a chemical compound at a level in excess of an established tolerance or action level, or if the residue detected has no approved tolerance. Under the authority of the FMIA, PPIA, and EPIA, FSIS administers the U.S. National Residue Program (NRP) for Meat, Poultry, and Egg Products which is an interagency program designed to identify, rank, and analyze for chemical contaminants in meat, poultry, and egg products.

The NRP is developed in consultation with the Surveillance Advisory Team (SAT) which is comprised of technical experts from the following three principal U.S. government agencies: FSIS, FDA, and the Environmental Protection Agency (EPA). The SAT meets annually to decide which compounds represent a public health concern and warrant inclusion in the NRP scheduled sampling plans. These agencies work together to create the annual sampling plan, based on the following:

• prior NRP findings of chemical residues in meat, poultry, and egg products
• FDA veterinary drug inventories completed during on-farm visits
• investigation information and pesticides and environmental contaminants of current importance to EPA

The NRP consists of 3 separate, but interrelated, chemical residue testing programs:

• scheduled sampling (Tier 1)
• targeted sampling at the production or compound class level (Tier 2)
• targeted sampling at the herd/flock or compound class level (Tier 2)

As audited, NRP was implemented at all establishments and non-compliant results were adequately followed by the FSIS and FDA to determine the root cause.

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

9. Closing meeting

The closing meeting was held in Washington, DC with representatives from the FSIS and USDA on September 27th, 2019. At the meeting, a summary of the preliminary findings from the audit were presented by the CFIA lead auditor.

10. Conclusions

Overall, the audit showed that food safety system in the U.S. is performing as intended in an adequate manner and generally demonstrate an acceptable implementation in bovine, swine and poultry meat inspection systems in a manner to be equivalent to that of Canada. The audit report includes the conclusions and recommendations for U.S. to address the deficiencies identified during the audit.

11. Recommendations

CFIA recommendations	FSIS actions plans and comments
All establishment specific findings be corrected and verified in a timely fashion.	August 5, 2020 The FSIS has verified that the establishments have taken appropriate corrective actions, as necessary, to address the establishment-specific findings and these corrective actions comply with FSIS regulations. In reference to Canada's finding that "the allergen program does not include the priority allergen in Canada," FSIS incorporated a hyperlink to Canada's list of allergens when updating the FSIS export library page on March 27, 2020, to ensure compliance with Canadian import requirements. In the FSIS Export Library, FSIS added text with the hyperlink under Labelling Requirements, Paragraph A. General Labelling Requirements, Number 1. Canadian mandatory label requirements, Letter e., "Allergens in the Ingredient List. A list of ingredients considered to be allergens by Canada can be found on the CFIA webpage under the document list of ingredients and allergens on food labels. In response to the presence of more than 2 cm aortas on harvested hearts in multiple establishments, FSIS performed a comprehensive update of the FSIS export library page on March 27, 2020, in coordination with CFIA to ensure compliance with Canadian import requirements. In the FSIS Export Library, under Animal Production and Slaughter Requirements, Letter B., FSIS added, "A heart (other than the heart of a domesticated rabbit or of a bird that is not an ostrich, rhea or emu) must be opened or inverted and have all blood clots and attached blood vessels removed". FSIS also included a direct hyperlink to the relevant Canadian regulations. In reference to the cleaning of trailers after transporting chickens, FSIS does not specifically require establishments to clean trailers or cages after they are emptied of chickens. The cleanliness of trailers and cages is usually addressed through the HACCP system at the live bird receiving step in the hazard analysis. Cleaning of cages and trailers is considered a best practice that establishments can use to reduce the pathogen levels that are introduced at this step. The establishment is required to support its hazard analysis decisions and overall HACCP system. If they can demonstrate that pathogens are adequately controlled through other measures, cage cleaning may not be necessary.
Implement a mechanism for signing official to verify the product traceability and eligibility to export to Canada when a meat product is exported from an establishment other than slaughter/processing establishment. Implement procedures to segregate Canada eligible and ineligible meat and meat products at establishments approved for export to Canada.	August 5, 2020 Subsequent to the Canadian audit of the U.S. food safety system, a comprehensive update of the FSIS Export Library page was initiated on March 27, 2020, in collaboration with CFIA. In accordance with the updated Safe Food for Canadians Regulations, FSIS has implemented a mechanism to identify the slaughter/processing establishments in the "Remarks" section of FSIS Form 9135-3 to verify product traceability and eligibility of the source materials for the export of meat products to Canada when exported from an establishment other than the slaughter/processing establishment. The FSIS Export Library page was updated on March 27, 2020, in accordance with the Safe Food for Canadians Regulations, to identify Canada-eligible products from ineligible products. Exporters are required to maintain traceability of their products by including the slaughter/processing establishments in the "Remarks" section of FSIS Form 9135-3. This provides additional verification of all eligible establishments that have been involved in the production of the final product.
The NR follow-up, including onsite verification activities completed by FSIS to verify an operator's corrective actions are documented. The weekly meeting and the MOI are completed and documented in establishments as required by the FSIS directive 5010.1.	August 5, 2020 In reference to Canada's finding that "the CA is not required to document follow up to close NRs," FSIS assures Canada that this statement is not accurate. FSIS verifies that the establishment has taken all necessary actions to return to compliance with the applicable regulation(s) found to be noncompliant. When the regulations require specific corrective actions, the IPP verify that the establishment meets those regulatory requirements (see 9 CFR 417.3, 416.15). When the establishment has returned to compliance with all regulations found noncompliant in the NR, IPP mark the NR and the associated inspection task as "completed." This documentation record indicates in PHIS the establishment's return to compliance. PHIS will not consider the inspection task complete until the inspector documents that the establishment returns to compliance. The verification may be documented in the establishment weekly meeting in accordance with FSIS Directives 5010.1 Rev. 2- PDF (64.5 kb) and 5000.1 Rev 5 - PDF (456 kb). Assigned FSIS inspectors at the individual establishments were instructed to meet with plant management at least weekly, discussing the events of that week and to document their observations in accordance with FSIS Directives 5010.1 Rev. 2.
Implement procedures to ensure that ante-mortem inspection of poultry from each farm is completed within 24 hours before the slaughter.	August 5, 2020 FSIS regulations for poultry slaughter do not mandate specific frequencies for conducting ante-mortem inspection. 9 CFR 381.70 states that "an ante mortem inspection of poultry shall, where and to the extent considered necessary by the Administrator and under such instructions as he may issue from time to time, be made of poultry on the day of slaughter in an official establishment." While every bird is not required to receive ante-mortem inspection, FSIS public health veterinarians and inspection personnel are present throughout the entire slaughter process and use their professional judgment and knowledge to determine the desired frequency of ante-mortem inspection according to post-mortem dispositions, flock conditions, weather concerns, etc. While FSIS may perform ante-mortem inspection of each poultry lot, this is not a prescriptive FSIS requirement. FSIS Directive 6100.3 describes the FSIS ante-mortem inspection procedures.
Implement retained water control program at the bison slaughter establishments as per the Canadian requirements as stipulate in the Canadian Control Programs: water retention in edible raw red meat products.	August 5, 2020 On March 27, 2020, the FSIS Export Library for Canada was updated to include the following statement: "Retained Water: Industry should be aware that Canada has the following restrictions on retained water to inform industry that they must implement a retained water program to ensure exported product meets Canadian import requirements.
Implement preventive control plans at all establishments involved in manufacturing, processing, treating, preserving, grading, packaging or labelling food as per the Canadian requirements.	August 5, 2020 On March 27, 2020, the FSIS Export Library page for Canada was updated to include the following statement under the section entitled, Eligible FSIS Non amenable (Voluntary) Product: "All Non amenable (Voluntary) Products must be produced under a HACCP plan or FSMA-compliant preventive controls" to inform industry of this requirement and ensure that exported product meets Canadian import requirements.
NRP review: control procedures to demonstrate compliance for chemicals with Canadian MRL's but not in scope of the NRP. The list of chemicals includes: altrenogest, amoxicillin, amprolium, apramycin, avilamycin, bacitracin, buquinolate, ceftiofur, cepharin, clopidol, closantel, decoquinate, derquantel-dichlorvos, diclazuril, dinitolmide, halofuginone, lasalocid, maduramicin, monensin, narasin, nicarbazin, novobiocin, ormetoprim, robenidine, salinomycin, semduramicin, sulfabenzamide, sulfacetamide, sulfaethoxypyradizine, sulfaguanadine, sulfanilamide, tiamulin, toltrazuril, tricaine, tylvalosin, trenbolone, megestrol, melengestrol, hexestrol and zeranol. Separate sampling numbers for tier 1 and tier 2 NRP sampling.	August 5, 2020: Since the 2019 audit, FSIS has advanced NRP testing by employing a next generation multi-residue screening method (CLG-MRM3) to strengthen its ability to detect animal drug residues. The CLG-MRM3 is an improvement over the previous multi-residue screening (CLG-MRM1) method due to the use of more sensitive instrumentation. Additionally, the number of animal drug residues analyzed in a sample has increased from 92 to 107 compounds. The following drug residues are included in the NRP: Amoxicillin, apramycin, ceftiofur, cepharin, derquantel-dichlorvos, hexestrol, lasalocid, megestrol, melengestrol, monensin, narasin, salinomycin, sulfaethoxypyradizine, sulfanilamide, tylvalosin, and zeranol. Through consultation and collaboration with our federal partners, the residues listed below fall in the following categories; FDA has not approved the use/application of the following drugs in any food-producing animals; therefore, they cannot be used on label in food-producing animals in the United States: Buquinolate, closantel, dinitolmide, sulfabenzamide, sulfacetamide, toltrazuril, tricaine. FDA has indicated that no withdrawal period is necessary for residues of the following drugs to deplete to or below the concentrations considered to be safe ("tolerance not required"); therefore, residue testing is not necessary: Avilamycin, trenbolone Due to veterinary drug inventories obtained during on-farm visits and investigations, FDA does not believe that residue testing of the following drugs is of priority for inclusion in the NRP because these drugs are not commonly used in food-producing animals: Altrenogest, amprolium, bacitracin, clopidol, decoquinate, diclazuril, halofuginone, maduramicin, nicarbazin, novobiocin, ormetoprim, robenidine, semduramicin, sulfaguanadine, tiamulin As analytical techniques and methodologies advance, FSIS will work closely with the FDA to prioritize veterinary drug residues that have Canadian MRLs and are not in scope of the NRP, with the goal to incorporate high priority residues into future iterations of the multi-residue drug method as appropriate. For separate sampling numbers for tier 1 and tier 2 NRP sampling, the Surveillance Sampling (formerly known as Tier 1) is the sampling of specified slaughter subclasses for chemical residues at the time of slaughter, after a carcass has passed ante-mortem. inspection. In fiscal year (FY) 2019, 8,225 samples were planned (FY 2019 Residue Sampling Plans) under the scheduled sampling plan. In FY 2019, 7,767 samples were collected and analyzed using ten analytical methods to detect approximately 250 different veterinary drugs, pesticides and environmental contaminants (FY 2019 Residue Sample Results). Under the Inspector-Generated Sampling (formally known as Tier 2), FSIS inspectors conduct Kidney Inhibition Swab (KIS™) tests on animals suspected to have violative levels of chemical residues. FSIS inspectors use professional judgment to determine which samples to collect for analysis. Inspectors perform a KIS™ test on any carcass suspected of containing violative levels of chemical residues and on any carcass exhibiting signs of systemic conditions (e.g., septicemia, peritonitis, pyemia). In FY 2019, FSIS inspectors performed 174,308 Kidney Inhibition Swab (KIS™) tests on animals suspected of containing a violative residue. Of those 174,308 samples, 3,569 KIS™ positive samples were submitted to field service laboratories for further analysis.