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
8. Slaughter and Processing Controls
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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.
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.
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.
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.
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 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].
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 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.
The FSIS is asked to provide the time line by which the FSIS notice will be implemented.
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.
"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.
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"
- 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 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.
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 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.
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.
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 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.
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.
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.
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.
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 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.
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.
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.
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.
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