CFIA Assessment of Establishment 38, XL Foods Inc.
Section 5: Conclusions and Recommendations

5.1 Food Safety Controls

This assessment examined four areas relating to Establishment 38, XL Foods Inc.'s food safety controls. First, the in-depth establishment review noted deviations from the establishment's documented E. coli O157:H7 control measures and sampling and testing procedures. The establishment was unable to demonstrate through its documentation that it was consistently and effectively implementing it's agreed upon control program. The detection of E. coli in slaughter facilities is not uncommon, and plants are expected to have adequate measures in place to monitor higher than normal detection rates and modify control measures accordingly. This trend analysis was not always conducted consistently.

In the three remaining areas (i.e. pre-resumption of operations inspection, carcass sampling and testing, and review of cutting and de-boning operations under temporary licence), which followed the in-depth establishment review, the CFIA found that the establishment's control measures were effectively controlling the risk of contamination.

5.2 Corrective Actions

During the in-depth establishment review, the CFIA also observed some deficiencies with respect to sanitation and maintenance. In the later reviews (i.e. pre-resumption of operations inspection, carcass sampling and testing, and review of cutting and de-boning operations under temporary licence), the Agency found that appropriate measures had been taken to address these issues.

Between September 12 to 18, 2012, the CFIA issued six CARs related to deficiencies that contributed to the suspension of the establishment's licence. During the limited operations related to cutting and de-boning, the CFIA found that the establishment was effectively implementing corrective action plans relating to these CARs.

Overall, the CFIA findings and observations indicate that Establishment 38, XL Foods Inc., has made improvements in the following areas:

• Demonstrating a stronger management commitment to food safety;
• Performing cleaning and sanitation procedures;
• Adequately implementing sanitary practices with respect to de-boning and cutting;
• Effectively implementing sampling and testing protocols for trim;
• Identifying and responding to identified deficiencies in a timely and effective manner;
• Cooperating with the CFIA with respect to the timely provision of information;
• Maintaining the cleanliness of their employee facilities;
• Addressing maintenance issues identified in the reviews; and
• Employee engagement on food safety matters, and employee training.

5.3 Recommendations

In consideration of the above, the CFIA recommends that the suspension of the licence to operate Establishment 38, XL Foods Inc., be lifted and that the establishment be allowed to resume slaughter and processing operations at the establishment, under the following conditions:

• Until further notice, for all production days with increased E. coli O157:H7 results above background levels (high event days), XL Foods Inc. will immediately provide to the CFIA documentation demonstrating its trend analysis and how it has implemented its event period protocols.
• Upon restart of operations, the operator will follow its written plan as submitted to the CFIA for limiting animal throughput. As controls are found to be effective, the operators plan will be in place to gradually increase the slaughter and processing throughput subject to CFIA approval. The plan will remain in effect for as long as necessary to enable XL Foods Inc. and the CFIA to monitor the effectiveness of its enhanced food safety controls.
• Operations will not commence until a satisfactory pre-operational inspection has been completed by the CFIA in all rooms associated with slaughter and processing, prior to the re-start of operations and on every day of operation during the CFIA enhanced inspection period.
• Until further notice, any private laboratory used by Establishment 38, XL Foods Inc., for the purpose of product testing will be directed by XL Foods Inc. to provide all product test results directly to the CFIA, as soon as they are available.
• All meat products will be held by XL Foods Inc. until all related CFIA and XL Foods Inc. test results are received, reviewed, and found acceptable by the CFIA.

The above conditions remain in effect for as long as deemed necessary to ensure the meat products produced at Establishment 38, XL Foods Inc., comply with the Meat Inspection Regulations (MIR) and in order to protect public health and safety. Further, pursuant to s. 29(6) of the MIR, XL Foods Inc. shall comply with all of these conditions of the licence to operate the establishment. A failure to do so may result in the establishment's licence being suspended again.

In addition, the CFIA should implement the following enhancements to its oversight:

• Interim onsite additional inspection resources should be assigned to provide support to inspection staff (i.e. one inspection manager) and to assess the effectiveness of implementation of the enhanced CVS daily tasks. (i.e. one inspection resource). The continued oversight of the establishment's HACCP system will ensure effective implementation of preventative measures taken by the establishment.
• In addition to measures taken by the establishment, the CFIA will implement an enhanced sampling protocol to monitor the effectiveness of the establishment's control program for E. coli O157:H7 in raw beef products. The enhanced sampling protocol encompasses testing for generic E. coli and E. coli O157:H7 for trims and ground beef. (Generic E. coli testing is conducted to determine if sanitation and good manufacturing practices issues may be occurring in the establishment).

The establishment's readiness to move from enhanced oversight to normal operations will be determined by the CFIA when:

• The enhanced sampling plan has been completed with satisfactory results;
• The CFIA has verified that all of the establishment's corrective actions have been effectively implemented; and
• The establishment has demonstrated effective implementation of planned enhancements to their food safety controls.

If at any point, the CFIA determines that the establishment's controls are not effectively controlling food safety risks, the establishment may be subject to immediate enforcement measures, including but not limited to suspension of the licence to operate.