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

1. Introduction

The Canadian Food Inspection Agency (CFIA) conducted an audit of the United States' meat and poultry food safety inspection system from February 5th, through 22nd, 2013.

The audit began with an opening meeting held in Washington DC, with the participation of representatives from the Central Competent Authority (CCA), the United States Department of Agriculture - Food Safety and Inspection Service (USDA-FSIS) - and the auditors from the CFIA. The meeting was attended by additional CFIA personnel via teleconference.

2. Audit Objective, Scope, and Methodology

This was an ongoing equivalence verification audit with special emphasis on:

1. Inspection and certification of meat and meat products for export to Canada.
2. Inspection controls in processing and slaughter establishments, including the following specific elements, in United States facilities eligible to manufacture product for export to Canada:
   • E. coli O157:H7 testing and control measures in raw beef manufacturing facilities;
   • Listeria testing and control measures in Ready to Eat (RTE) meat producing facilities;
   • Abattoir programs related to the suitability of animals presented for slaughter (residue and disease status), humane handling, and the control of evisceration and dressing processes in traditional and HACCP based inspection model plants (HIMP);
   • Codex Alimentarius Principles of HACCP implementation;
3. Government oversight and support activities (e.g. laboratory).

In pursuit of this objective, the CFIA used a risk-based procedure to determine the audit scope, which included an analysis of country performance, production types and volumes, and port-of-entry (POE) testing results.

The CFIA auditors were accompanied throughout the entire audit by representatives from the CCA and representatives from Headquarters and District Offices. Program effectiveness determinations focused on government controls and oversight within five areas of risk: (1) sanitation controls, including the implementation and operation of Sanitation Standard Operating Procedures (SSOP), (2) animal disease controls, (3) slaughter and processing controls, including the implementation and operation of Hazard Analysis/Critical Control Point (HACCP) programs and a testing program for generic E. coli, (4) laboratory (residue) controls, and (5) enforcement controls, including a government verification testing program for Salmonella spp, Escherichia coli 0157:H7, Listeria monocytogenes and species verification.

Administrative functions were reviewed at CCA headquarters, one district office, and twelve (12) local inspection offices at USDA registered establishments, during which the auditors evaluated the implementation of management control systems which ensure inspection, verification, and enforcement were being implemented as intended.

As discussed above, twelve (12) establishments were selected from the list of USDA establishments that are currently exporting meat and poultry products to Canada. During the establishment visits, particular attention was paid to the way government and establishments interact to control hazards and prevent non-compliances that threaten food safety.

Additionally, one microbiology laboratory was audited to verify its ability to provide adequate technical support to the inspection system.

3. Legal Basis for the Audit and Audit Standards

The audit was undertaken under the specific provisions of Canadian laws and regulations, in particular:

• The Meat Inspection Act
• The Meat Inspection Regulation 1990

4. Background

The United States is eligible to export raw and processed red meat products, raw and processed poultry products to Canada. Between January and December 31, 2012, the United States exported 713 073 375 kilograms of raw and processed meat and poultry products to Canada.

The USDA-FSIS inspection system was last audited by the CFIA in an audit that was delivered in two (2) phases. The first phase took place from December 1 to 11, 2009 where twelve (12) Ready to Eat (RTE) meat establishments were audited. The second phase took place from February 24 to March 11, 2010, where twenty-seven (27) slaughter and processing establishments were audited.

During the scope of this two-phase audit in 2009-2010:

• Four (4) establishments were temporarily removed from the USDA-FSIS list of establishments that are eligible for export to Canada;
• One (1) establishment was found to have conditions that were not immediately rectifiable, that did not pose an imminent threat to public health but would warrant decertification if not corrected within thirty days from the time of issuance; and
• Three (3) establishments were found to have conditions that would normally have warranted delistment but were not delisted as adequate corrective measures were taken and/or acceptable action plans were presented at the time of the audit.

Acceptable action plans were presented by USDA-FSIS for all of the above establishments of concern and all have retained or regained the eligibility to export to Canada.

5. Government Oversight

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

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

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

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

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

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

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

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

FSIS Response:

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

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

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

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

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

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

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

6. Sanitation Controls

The inspection system must contain requirements for sanitation, for sanitary handling of products, and for the development and implementation of sanitation standard operating procedures (SSOP). The pre-operational and operational sanitation standard operating procedures should minimize direct and indirect contamination of meat products to the greatest extent possible. A properly implemented sanitation program shall ensure that establishment, facilities, and equipment are clean and sanitized prior to the start of operations, and includes the operational sanitation procedures, which will ensure that the appropriate hygiene is maintained during operations.

During the on-site portion of the audits, several observations were noted related to the verification by the USDA inspection staff of effective implementation of sanitation procedures. Observations related to pre-operational and operational sanitation procedures in addition to sanitary design of equipment were observed in several food processing areas. Some of them were more serious in nature as product being produced was directly affected.

In those situations, both USDA-FSIS auditors and local inspection staff reacted appropriately to the non-compliance. Establishments developed and implemented corrective actions and preventive measures addressing the concerns identified during the audit.

In one establishment producing RTE meat products, it was learned by the CFIA auditors that the room where exposed RTE hot dogs are packaged was allowed to operate for periods of up to four (4) days without a full dismantling, cleaning, and sanitization of the room and equipment.

FSIS Response:

IPP are to verify that establishments that choose to use a Less Than Daily (LTD) sanitation frequency are satisfying all of the regulatory requirements regarding sanitation. IPP are to verify that the establishment maintains compliance with 9 CFR 416.1 through 416.5 for sanitation performance standards (SPS) and is meeting the regulatory requirements set out in 9 CFR 416.11 through 416.16 for Sanitation SOPs. IPP are also to verify that establishments have included their LTD sanitation procedure for processing operations in their food safety system (e.g., a prerequisite program, Sanitation SOP, or HACCP). Equipment such as continuous ovens may not require daily sanitation. If the establishment can justify LTD cleaning procedures, they must be able to support their decisions as part of the requirements to maintain their food safety system.

FSIS evaluates performance of individual IPP annually. Employee performance is documented using IPPS (In-Plant Performance System) Reviews. Supervisory personnel evaluate IPP knowledge and application of FSIS policies, requirements, procedures to achieve FSIS strategic goals at each assignment on an annual basis.

Additional information regarding Less than Daily (LTD) sanitation is outlined in:

1. FSIS Directive 5000.1 PDF (285 kb)
2. Public AskFSIS Q&As on LTD sanitation
3. AskFSIS Q&As clarify LTD procedures are not acceptable in slaughter areas.

In addition to sanitation requirements in 9 CFR 416, RTE products are subject to additional specific sanitary requirements under 9 CFR 430 rule that require validation or testing to measure effectiveness of sanitation. Control of Lm procedures may be documented in HACCP, SSOP, or PR programs. Requirements vary according to which ALTERNATIVE the establishment produces a particular product. Requirements for each ALTERNATIVE are weighted per RISK of the particular product category. Deli hot dogs under ALTERNATIVE #3 are clearly in the highest risk category and subject to the most requirements. Each alternative (1, 2, or 3) has more stringent requirements associated with risk. See FSISDIR 10,240.4 and associated documents: See Attachment 1.1 "Control requirements for Lm", p. 17 of Lm Control Guidelines, 2012 PDF (1.05 mb). The FSIS Enforcement, Investigations and Analysis Officer (EIAO) conducts comprehensive food safety assessments (FSA) at establishments in which they consider all food safety aspects that relate to that establishment and its products, the nature and source of all materials received, the establishment's processes, and the environment of the establishment. The EIAO primarily focuses on the design and validity of the hazard analysis, HACCP plan; Sanitation Standard Operating Procedures (Sanitation SOPs), pre-requisite programs, testing programs, e.g., its generic E. coli written procedures; and any other programs that constitute the establishment's food safety system.

FSIS has verified that the establishment referenced above maintains compliance with 9 CFR 416.1 through 416.5 for sanitation performance standards (SPS) and is meeting the regulatory requirements set out in 9 CFR 416.11 through 416.16 for Sanitation SOPs. The establishment is following FSIS regulations identified for LTD sanitation programs as outlined in FSIS Directives 5000.1 and 5000.5. In addition to the establishment's evaluation of its own program and FSIS in-plant inspection personnel oversight of the program, an EIAO evaluated the program and its effectiveness during the last FSA at the establishment and found it to meet FSIS expectations of a LTD program.

7. Animal Disease Controls

CFIA auditors evaluated Animal Disease Controls, including review of mechanisms for animal identification, control of condemned and restricted product, implementation of the requirements for non-ambulatory disabled cattle and specified risk materials (SRM), and procedures for sanitary handling of returned and reconditioned product.

The auditors learned that ante-mortem inspection procedures for poultry did not necessarily involve inspection by USDA-FSIS of all lots of live poultry entering establishments.

FSIS Response:

Per FSIS Directive 6100.3 and 9 CFR 381.70(a) Inspection program personnel (IPP) are to perform ante-mortem inspection on the day of slaughter. 9 CFR 381.70(a) provides that FSIS is to perform an ante-mortem inspection of poultry, where and to the extent considered necessary by the Administrator (i.e., as needed). In poultry establishments, Inspectors In Charge (IIC's) have the discretion to have IPP perform ante-mortem inspection on each lot of poultry at their establishments, even though ante mortem inspection of every lot is not a mandatory requirement or specified as a country requirement in the Export Library for Canada. Additional information about ante mortem inspection such as instructions for doing lot by lot inspection can be found at the following link.
Ante-mortem Inspection PDF (153 kb)

CFIA Follow-up:

FSIS is requested to amend the requirements in the export library to include lot by lot ante-mortem inspection in all USDA-FSIS official establishments producing poultry meat products for export to Canada.

The auditors found that red meat slaughter and processing establishments did not consistently identify the risk of Bovine Spongiform Encephalopathy (BSE) as a hazard likely to occur in their HACCP system.

FSIS Response:

FSIS requires all beef slaughter and processing establishments prior to operations to reassess for any hazards associated with BSE and SRMs.

Only hazards determined to be reasonably likely to occur are required to be addressed in HACCP. Potential food safety hazards may be adequately and just as effectively addressed by well-designed pre-requisite (PR) programs. Many establishments will use a combination of HACCP, SSOPs and pre-requisite programs to control SRMs. Although SRMs may be found in cattle of all ages (e.g. tonsils; distal ileum), certain beef slaughter or processing establishments may be able to support that SRMs are not a hazard reasonably likely to occur. FSIS regulations (9 CFR 310.22(e)(1) require beef establishments to incorporate SRM controls (HACCP, SSOP) or preventions (PR programs) to support hazards of SRMs from being likely to occur. For example, beef grinding establishments may determine that SRM is not a hazard reasonably likely to occur since they as part of a PR program receive only boneless beef or cuts from cattle LT30. There are no likely hazards of SRMs associated with the processing of boneless beef. Other establishments may require purchase specifications as a pre-requisite program to support their decision. FSIS will accept decisions that are reasonably supported. FSIS conducts in-depth Food Safety Assessments at all FSIS official establishments at least once every 4 years or more often for cause.

CFIA Follow-up:

FSIS is requested to review hazard analysis at the concerned slaughter establishment to ensure that SRM is identified as a hazard likely to occur and is properly addressed. Similar approach should be followed in all USDA-FSIS official beef slaughter establishments exporting meat products to Canada.

The United States strengthened their feed ban in 2008. This enhancement prohibits the use of the brain and spinal cord derived from cattle 30 months of age and older to be use in any animal feed. When compared to Canada, items such as the skull, the trigeminal ganglia, the eyes, the palatine tonsils and the dorsal root ganglia from OTM cattle and the distal ileum of cattle of all ages which would be considered as SRM in Canada, are considered inedible in the United States and while not allowed into the human food chain, are allowed into the normal inedible rendering stream.

FSIS Response:

The US Food and Drug Administration (FDA) stopped allowing ruminant meat & bone meal to be fed to ruminants in 1997. In beef slaughter facilities, prior to 2008, all of the SRMs could go to rendering, and then the rendered material could be fed to non-ruminants. After the 2008 rule, brain and spinal cord from cattle 30 months and older have to be disposed of by some non-feed method, and the remaining rendered material is still fed according to the 1997 rule (to non-ruminants). Today, most slaughter facilities vacuum out the brain and spinal cord of their 30 month & older cattle, into a container (a tank or mini-bulk) and once full the tank usually goes to the landfill. The effectiveness of the US feed ban was taken into consideration by the OIE as part of the process to determine the BSE risk category of the US. The US was classified as having negligible risk for BSE on May 28, 2013.

The auditors found inconsistent controls in place to ensure that exteriorized brain tissues falling from OTM animals' stunning hole onto the floor are not directed into the SRM stream. Of the three beef slaughter establishments observed, one establishment vacuumed the heads of OTM animals and corked the stunning hole, a second vacuumed the head of OTM animals but did not plug the stunning hole; and a third did not apply either of these controls.

FSIS Response:

Composition and standards for inedible blood meal are under FDA and APHIS jurisdiction, not FSIS. FDA indicates when the Canadians implemented their enhanced feed controls, they interpreted their SRM definition to include drippings from the nasal cavity and stun hole. Ultimately, standards for inedible blood are not under FSIS jurisdiction.

CFIA Follow-up:

FSIS is requested to coordinate a response with FDA/APHIS to provide assurances that inedible dried bovine blood and blood meal products exported to Canada meet Canadian import requirements. Please refer to the CFIA's Animal and Public Health Import Requirements for Rendered and Inedible Products (January 8, 2013).

CFIA import policy regarding inedible dried bovine blood and blood meal products from the U.S. requires Official Zoosanitary Export Certificate stating that their blood collection method prevents contamination of blood with SRM (such as CNS from OTM cattle). FSIS is requested to make appropriate amendments in the export library.

The auditors also learned that of all the beef establishments visited, none had validation evidence to establish that all dorsal root ganglia of animals over thirty months was being removed from the edible and inedible meat streams either prior to or at the time of boning. It was explained that the boning practices were a control measure for the related BSE hazard.

FSIS Response:

FSIS' position is that dorsal root ganglia (DRGs) are known to be closely associated with the beef vertebral column and that hand and equivalent boning procedures do not pose a significant risk for introducing SRMs into edible product. FSIS has indicated a willingness to study this further [FR Notice 03-025F - July 13, 2007].

FSIS requirements in 9 CFR 318.24 prohibit the use of SRM vertebral bones in production of beef Advanced Meat Recovery (AMR) product and preclude any amount of CNS and ganglial tissue in AMR product (i.e. meat). Although FSIS HACCP and SSOP requirements already require establishments to validate and maintain programs to ensure effectiveness, FSIS has not determined that there is a significant risk to public health and a basis for IPP to expect more from establishments regarding DRG.

CFIA Follow-up:

FSIS is requested to provide the validation demonstrating that hand boning and equivalent boning procedures do not pose a significant risk of introducing SRMs into edible product. They are also requested to share with CFIA the status of the proposed study [FR Notice 03-025F - July 13, 2007] on the above subject.

8. Slaughter and Processing Controls

CFIA auditors reviewed Slaughter/Processing Controls, which included ante-mortem inspection procedures, ante-mortem disposition, humane handling and humane slaughter, post-mortem inspection procedures, post-mortem disposition, implementation of a testing program for generic E. coli in slaughter establishments and implementation of HACCP systems in all establishments

The review of applicable legislation and procedures indicated that USDA-FSIS continues to maintain equivalency with respect to most of the above stated controls.

8.1 Humane handling and animal welfare

During this audit, issues related to humane handling and slaughter of food animals presented for slaughter in USDA-FSIS inspected establishments were noted, specifically as regards:

• Poultry: USDA-FSIS regulatory authorities for the humane handling and slaughter of poultry are dissimilar from Canadian requirements, and there is a concern that this situation may lead to lack of compliance with Canadian humane handling and slaughter requirements in United States establishments eligible for export to Canada. The auditors discovered the following facts as regards this issue:
  • Ante-mortem inspection/examination is not a USDA regulatory requirement in poultry and ante-mortem examination of each lot of incoming birds was not conducted in all of the poultry establishments visited.
  • If any ante-mortem related findings were detected, a noncompliance report cannot be issued for poultry as there is no supporting regulation. Only a MOI (memorandum of interview) can be placed on file.
  • There is no USDA-FSIS regulatory support for controlling dead on arrival poultry numbers.
  • There is no regulation requiring that poultry be stunned prior to bleeding in United States establishments.
  • Poultry animal welfare findings must include and be related to bruising (or more accurately as explained by local USDA-FSIS staff, an "increase in bruising") before regulatory based action can be taken. Issues that do not result in bruising may be subject only to MOI.
  • Ritual slaughter of poultry is exempted from United States regulation. This is unlike the Canadian situation, where such slaughter is permitted only when it is done in a manner that complies with specific regulatory requirements requiring that every animal that is ritually slaughtered is "restrained and slaughtered by means of a cut resulting in rapid, simultaneous and complete severance of the jugular veins and carotid arteries, in a manner that causes the animal to lose consciousness immediately.

FSIS Response:

Per FSIS Directive 6100.3 and 9 CFR 381.70(a) IPP are to perform ante-mortem inspection on the day of slaughter. 9 CFR 381.70(a) requires FSIS to perform an ante-mortem inspection of poultry, where and to the extent considered necessary by the Administrator (i.e. as needed). In poultry establishments, Inspectors In Charge (IIC's) have the discretion to have IPP perform ante-mortem (AM) inspection on each lot of poultry at their establishments, even though AM on each lot is not a mandatory requirement or specified as a country requirement in the Export Library for Canada. Additional information about ante mortem inspection such as instructions for doing lot by lot inspection can be found at the following link:
Ante Mortem Inspection PDF (153 kb)

If ante mortem related findings are detected, and those findings plainly show a disease or condition, under 9 CFR 381.80 to 381.93, inclusive, that would cause condemnation of the carcasses on post mortem inspection, 9 CFR 381.71(a) provides that FSIS condemns the affected poultry. 9 CFR 381.71(a) also prohibits birds which FSIS condemns on ante-mortem inspection from being dressed or conveyed into any department of the official establishment where poultry products are prepared or held. If the establishment dressed the condemned birds or conveyed them into any department where poultry products are prepared, then FSIS would issue a noncompliance record. 9 CFR 381.71(a) also requires the establishment to dispose of poultry which has been condemned by FSIS on ante mortem inspection to be disposed of as provided in 9 CFR 381.95. If the establishment fails to dispose of the condemned poultry as provided in 9 CFR 381.95, then FSIS would issue a noncompliance record.

CFIA Follow-up:

FSIS is requested to amend the requirements in the export library to include lot by lot ante-mortem inspection in all USDA-FSIS official establishments producing poultry meat products for export to Canada.

FSIS Response:

DOAs are subject to disposal requirements on FSIS inspected official premises per 9 CFR 381.71 and 381.95. IPP verify that dead poultry are condemned and diverted to poultry product not intended for human food. 9 CFR 381.71(a) requires FSIS to condemn the dead on arrival poultry when performing ante mortem inspection. DOAs are documented on FSIS dead and condemned certificate, an official FSIS document, issued to establishment and maintained at the inspection office.

FSIS 9 CFR 416.2 requires establishments to maintain grounds in a sanitary manner. Improper handling of dead on arrival poultry on the official premise may provide harborage and breeding sites for pests. 9 CFR 416.2(a) requires establishments to have in place a pest management program to prevent the harborage and breeding of pests on the grounds. Failure to control dead on arrival poultry numbers is synonymous with failure to prevent harborage and breeding sites for pests and is considered insanitary. If a trend of incidents continues and FSIS determines that the establishment lacks process controls to prevent DOAs from being hung on the shackle and entering any department in the slaughter operation, then noncompliance will be documented as a demonstrated systematic failure. A directed Sanitation Performance Standards (SPS) verification task added to the Task Calendar in PHIS can be used to document SPS noncompliance citing 9 CFR 416.4(d), and with additional reference to 9 CFR 381.71(a) within the text of the NR. The above regulations indicate that FSIS has regulatory support for controlling poultry DOAs.

CFIA Follow-up:

FSIS is asked to assure CFIA that all USDA-FSIS official poultry establishments producing poultry meat products for export to Canada have controls in place to address the cause of excessive DOAs in an effort to prevent recurrence from a specific producer or transporter.

FSIS Response:

FSIS has no stunning requirement prior to bleeding. However, Regulation 381.65(b) states that poultry shall be slaughtered in accordance with good commercial practices in a manner that will result in thorough bleeding of the carcasses and assure that breathing has stopped prior to scalding. Regulatory actions for noncompliance with 9 CFR 381.65(b) include noncompliance records and potentially stopping the poultry line with a regulatory control action by inspection personnel.

Establishments that are approved to export product to Canada are required to stun poultry before slaughter per Canada's country requirements in the Export Library. As indicated in FSIS Directive 9000.1 inspection personnel are to verify country requirements as posted in the FSIS Export Library prior to certifying such product on the export certificates [FSIS Form 9135-3 for Canada].

CFIA Follow-up:

FSIS is asked to assure CFIA that USDA-FSIS official poultry establishments producing poultry meat products for export to Canada have controls in place to meet Canadian requirements, and to demonstrate that the FSIS inspectors can effectively detect and control ineffective stunning issues.

FSIS Response:

FSIS has instructions to IPP regarding verification of "good commercial practices" (GCPs) in FSIS Directive 6100.3 PDF (85 kb). A draft FSIS notice is being reviewed to address additional GCP verification to ensure consistency in use of NRs for poultry handling.

CFIA Follow-up:

The FSIS is asked to provide the time line by which the FSIS notice will be implemented.

FSIS Response:

There is no U.S. requirement to stun prior to bleeding poultry. The exemption of stunning before ritual slaughter applies only to livestock in the Federal Meat Inspection Act (FMIA). Per Canada requirements, ritual slaughter establishments are not required to stun before slaughter.

Requirements for Canada

"Canada's humane slaughter laws, requiring the stunning of poultry before slaughter, apply not only to domestic plants but also to plants that export product to Canada. The only exceptions to this requirement are ritual slaughter of poultry and decapitation of poultry without prior electrical stunning where stunning would result in excessive bone breakage." See "Slaughter and Documentation Requirements." in the FSIS export library for Canada.

CFIA Follow-up:

The FSIS is asked to amend the export library as follows:

"Canada's humane slaughter laws, requiring the stunning of poultry before slaughter, apply not only to domestic establishments but also to foreign establishments that export products to Canada. The only exception to this requirement is ritual slaughter of poultry: in accordance with Judaic or Islamic law in which the bird is restrained and slaughtered by means of a cut resulting in rapid, simultaneous and complete severance of the jugular veins and carotid arteries, in a manner that causes the animal to lose consciousness immediately"

• Swine:
  • At 2 out of 3 hog US establishments audited non-ambulatory hogs (hogs unwilling or able to walk) were physically moved (i.e. with a bobcat and loaders) to a pre-slaughter assembly area and kept there until moved again and stunned, bled and shackled. The auditor noted that none of the non-ambulatory hogs were stunned during the time taken to conduct the onsite barn audit. It was explained to the auditors that this practice was deemed acceptable and that there was no USDA regulatory authority being violated.
  • In one hog abattoir visited, animals that were dead on arrival and animals that had died in barn were not identified and controlled as required by United States regulation.

FSIS Response:

FSIS has not found transport of non-ambulatory swine by sled or bobcat loader to be automatically unacceptable or inhumane. FSIS verifies whether the establishment can demonstrate it is capable of moving nonambulatory swine in a humane manner. Many establishments will hold the nonambulatory swine until they recover, and present such animals for ante-mortem inspection. Any stressor hog that is not ambulatory when presented for ante-mortem inspection is identified as US Suspect, and can be slaughtered under the attention of the Public Health Veterinarian per 9 CFR 301 and 9 CFR 309.

CFIA Follow-up:

The FSIS is asked to amend export library as follows:

"No food animal shall be handled in a manner that subjects the animal to avoidable distress or avoidable pain, therefore, non-ambulatory animals will not be moved prior to stunning all USDA-FSIS official establishments producing meat products for export to Canada"

FSIS Response:

FSIS regulations require proper handling and identification of all DOA animals on premises per 9 CFR 309.3. The establishments sort the animals, but IPP continue to inspect and verify the establishment control of animals ineligible for the mark of inspection including swine condemned on AM (including DOAs). Whether under Swine HIMP or traditional inspection, IPP continue to verify each animal is accounted for (using establishment unique tags) and denatured prior to transport to a rendering facility or rendered on site.

CFIA Follow-up:

The FSIS is requested to provide assurance that inspection oversight is provided on proper handling and identification of all DOA and dead in barn (DIB) animals on premises as per 9 CFR 309.3.

8.2 Listeria monocytogenes control requirements for Ready-to-Eat (RTE) meat product

USDA-FSIS requires that establishments producing RTE meat products control the risk of Listeria monocytogenes in a manner that achieves zero presence of the organism in RTE products. The USDA-FSIS has published a guideline for determining if a meat product is RTE or not and to also categorize the Listeria risk category for the product. The guideline anticipates but does not mandate that the establishment operator strictly follows the guideline.

The CFIA auditors observed that in some of the establishments visited, validation of D log reduction specified as part of the guidelines' Listeria risk category process, were not followed.

In one of the establishments visited, where inspection was delivered under the Voluntary Reimbursable Inspection Service, RTE meat products were being prepared without adherence to Listeria control requirements, and in a manner that did not correspond with Canadian requirements.

FSIS Response:

The Listeria Rule (9 CFR 430.4) does not require specific log reductions; however, establishments are required to use post-lethality treatments that reduce or eliminate Lm or antimicrobial agents that suppress or limit growth of Lm to meet the requirements of Alternatives 1 and 2. If establishments in Alternative 1 or 2 do not meet the recommendations in the Listeria Guidelines for post lethality treatments (at least 1-log reduction of Lm), or antimicrobial agents (allows no more than 2-logs growth of Lm), and do not provide additional support for their process, they would not be in compliance with the regulation.

Information regarding 5 and 7 log reduction to meet lethality requirements is provided in section 8.4 of this report.

CFIA Follow-up:

CFIA requests that the FSIS shall not certify meat and meat products (e.g. closed-faced sandwiches) produced in establishments under Voluntary Reimbursable Inspection Service as of the date of publication of the final audit report. FSIS is requested to amend appropriately export library.

8.3 Mandatory testing for generic E. coli in abattoirs and certain raw meat processing establishments

USDA-FSIS regulations require that abattoirs and establishments producing certain types of raw meat products (e.g., ground beef) perform testing for generic E. coli for process control self-assessment purposes. The auditors learned that USDA-FSIS has introduced new rules under the USDA-FSIS Salmonella Improvement Program that no longer require generic E. coli testing when other measures are in place.

FSIS Response:

Poultry and market hog slaughter establishments that participate in the Salmonella Initiative Program (SIP) are required to test for Salmonella, Campylobacter (if applicable), and generic E. coli or other indicator organisms for process control purposes and to share the data with FSIS. Such establishments could request a waiver to reduce or discontinue the sampling frequency of generic E. coli testing. With the prevalent use of carcass antimicrobial interventions to control E. coli O157 and Salmonella, the value of generic E. coli process control monitoring of chilled carcasses per 9 CFR 310.25(a) is greatly diminished.

8.4 Cooling of heat treated meat products and poultry products

The auditors learned that USDA-FSIS allows certain establishments manufacturing cooked meat products to omit post-cook product cooling time-temperature controls as a CCP in the corresponding HACCP plans; a finished product testing program is accepted by USDA-FSIS as a suitable equivalent way to establish control for the risk of Clostridium perfringens and like organisms in these products.

FSIS Response:

In addition to meeting the requirements of the Listeria Rule, establishments must meet the requirements of 9 CFR 416, Sanitation, and 9 CFR 417, HACCP Systems. Producers of RTE products must support that they are maintaining sanitation in the processing environment according to 9 CFR 416, and preventing or controlling the food safety hazards in their product according to 9 CFR 417.2(a)(1) and documenting the support according to 9 CFR 417.5(a)(1). For RTE products, FSIS recommends that the establishment achieve lethality of pathogens (e.g., Salmonella) in the finished product, and stabilize the product to inhibit the growth of spore-forming bacteria (e.g., C. botulinum and C. perfringens). FSIS enforces requirements that pathogens are prohibited in RTE products.The establishment needs to be able to support that its product is RTE at the end of the process. In addition, if an establishment labels the product as RTE it is required to process the product to render it RTE, in accordance with 9 CFR 317.2(l) and 381.12(b).

Cooling is not required to be a CCP because it prevents pathogen growth rather than controlling pathogens in the product. Although the cooling process is not required to be identified as a CCP, the establishment would need to demonstrate that it is stabilizing the product. Otherwise, it would not meet the requirements of the HACCP regulations, as cited above.

To meet validation requirements (9 CFR 417.4), in addition to product testing, the establishment would need to provide scientific support (e.g., journal articles, guidelines, book chapters, challenge study results) demonstrating that their process is sufficient to produce a safe product.

CFIA Follow-up:

FSIS establishments are required to follow the FSIS - Appendix B (1999) Compliance Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization). Any alternate procedures must be approved by the FSIS to ensure proper cooling and pathogen control.

8.5 Salmonella control requirements in RTE meat products manufactured by a dry-cure process or other like process that does not involve heat treatment

The Canadian auditors learned during on-site activities that USDA-FSIS allows establishments to produce the above types of products without having to conduct validation of the lethality of the process for the required 5D log Salmonella reduction (non-heat treated RTE beef products)/ 7D log Salmonella reduction (non-heat treated RTE poultry products). It was learned that the validation step was part of a voluntary industry guideline, therefore not a mandatory step. One establishment operator did not have validation of D log reductions for all of the types of above products they manufactured. The study they had done in 2006 for some of their products was no longer entirely reflective of amended manufacturing practices, and did not reflect manufacturing steps for other RTE like products, including a number eligible for export to Canada. CFIA request that USDA-FSIS provide additional information to CFIA in regards to the specific 5 to 7 D reduction requirements in establishments that produce non-heat treated products and how USDA-FSIS verifies compliance to these requirements in establishments that are eligible to export to Canada.

FSIS Response:

To support that establishments are controlling the food safety hazards in their products, the FSIS Salmonella guidelines recommend achieving at least a 5 log reduction of Salmonella in meat products and a 7 log reduction of Salmonella in poultry products. Other log reductions may be used by the establishment as long as they are supported (e.g., through testing of source materials, as recommended by the guideline). If the establishment cannot support that they are controlling the food safety hazards in their products, they would not be in compliance with 9 CFR 417.5(a)(1), and would not be allowed to produce the product unless or until they can provide support for the process.

To meet validation requirements, FSIS requires all establishments have scientific support and they follow the process in their supporting documentation.

CFIA Follow-up:

CFIA will undertake further evaluation on USDA-FSIS official establishments exporting meat products to Canada to verify how they meet Salmonella control requirements in RTE meat products.

8.6 HACCP

HACCP controls were generally well performed and verified. However, a number of shortcomings were identified by the auditors as related to validation requirements (see items above) and the hazard identification processes required to design and maintain the establishments' HACCP systems. Specifically one processing establishment operator had failed to identify Listeria monocytogenes as a hazard likely to occur in RTE products made at the facility, a second beef establishment operator had failed to identify E. coli 0157:H7 as a hazard likely to occur in products made at the facility; and a third beef establishment operator had failed to identify BSE as a hazard. Identification of all hazards likely to occur is something that is mandatory under US and Canadian HACCP requirements.

The number of similar findings in different establishments is an observation that is discussed under section 5 above.

In one of the establishments visited, where inspection was delivered under the Voluntary Reimbursable Inspection Service model, HACCP requirements were not mandatory and were not all being implemented or verified in a manner consistent with Canadian requirements.

FSIS Response:

Non-official establishments under voluntary inspection are subject to SPS requirements. Non-official establishments are not subject to HACCP requirements. Only official establishments must have HACCP and SSOPs. Official establishments are responsible to support decisions in their hazard analysis. Establishments with no CCPs require close scrutiny; but it is possible to support such determinations. In official establishments, Lm and SRMs may be addressed by other than HACCP CCPs. E. coli O157:H7 is considered an adulterant in ground beef products and beef products intended for grinding. FSIS Inspection Program Personnel determine compliance with HACCP regulations based on decisions made in the establishment's hazard analysis. Establishments may utilize Prerequisite programs to support potential food safety hazards not reasonably likely to occur.

Establishments producing post-lethality exposed RTE product are required to consider whether Lm is a hazard reasonably likely to occur in their product, according to 9 CFR 430.4(a). However, they are not required to identify Lm as a hazard, if they prevent it through a Sanitation Standard Operating Procedure (Sanitation SOP) or a prerequisite program.

CFIA Follow-up:

As mentioned in 8.2, CFIA requests that the FSIS shall not certify meat and meat products (e.g. closed-faced sandwiches) produced in establishments under Voluntary Reimbursable Inspection Service as of the date of publication of the final audit report. FSIS is requested to amend appropriately their export library.

9. Laboratory Controls

CFIA auditor reviewed laboratory controls. The inspection system must have a laboratory control program, organized and administered by the national government, which includes random sampling of internal organs and fat of carcasses for residues identified by the exporting country's meat and poultry inspection authority or by CFIA as contaminants.

The laboratory audit was conducted using the same techniques (more specifically review of documents, review of records and observation of implementation) are commonly used for auditing accredited Canadian laboratories. The auditing activity began with the document review prior to the on-site visit, to ensure all the ISO 17025 requirements are documented within the laboratory's quality system manual. This review was then followed by on-site review of records that included but was not limited to management reviews, non-conformance reports, internal & external audit reports, employee training, equipment usage and maintenance, and traceable analytical testing information. Evidence of implementation of the quality system was obtained by direct observation (seeing requirement is met) and conducting interviews (knowing requirements).

The Eastern Laboratory's management and staff were very knowledgeable of their quality system and the assessment visit was conducted in a very open and cooperative environment. Based on the evidence obtained from the document review and the on-site visit, it was concluded that the Eastern Laboratory's testing system can be considered equivalent to a Canadian Laboratory's testing system.

10. Enforcement Controls

The CFIA auditors reviewed USDA-FSIS Enforcement Controls. These controls included the enforcement of inspection requirements and the testing programs for Salmonella spp, Escherichia coli 0157:H7, Listeria monocytogenes and species verification.

USDA-FSIS took the necessary enforcement actions when non-compliances were identified during on-site activities conducted during this audit. However, the number of similar shortcomings in different establishments is an observation that is important to the overall assessment of government controls, discussed under point 5 above.

11. Closing Meeting

The closing meeting was held in Washington on February 22nd, 2013 with USDA-FSIS. At the meeting, the preliminary findings from the audit were presented by the CFIA lead auditor.

12. Conclusions And Action Items

The USDA-FSIS has addressed the audit findings that were identified in 2 establishments during the audit visit.

CFIA accepts different Central Competent Authority (CCA) inspection requirements and procedures in approved foreign establishments eligible to export to Canada where an equivalence determination has been completed. When changes to CCA requirements and procedures are implemented, a re-assessment of the changes is needed to verify the suitability of the new requirements and procedures – this process also helps ensure that any appropriate adjustments to Canadian export requirements for the US are made at the same time to ensure ongoing bilateral equivalency.

The audit process underscores the need for ongoing technical discussions to occur between the Central Competent Authority (CCA) and the CFIA to maintain equivalency between our two systems.

However, the following items need particular attention from the FSIS:

• Animal welfare requirements for poultry and pork in the US
• Ante-mortem inspection procedures for poultry
• SRM controls in inedible products and appropriate validation regarding edible product
• Implementation of FSIS requirements for validation for 5-7 D reduction of Salmonella in US establishments producing non-heat treated RTE products
• HACCP requirements and implementation in FSIS regulated establishments

Overall, the audit showed USDA-FSIS's food safety system is performing as intended in an adequate manner.