What is the cleaning frequency for the smoker, and how long does it take for the creosote buildup to become noticeable? How clean does the smoker look like during Pre-Operational inspection that it passed QA and USDA inspection? How clean does the smoker look like during Operational inspection that it passed QA inspection?
Based on the cited regulations, this is a sanitation noncompliance. There is an excessive buildup of creosote in the smoker. Does the NR support the current retention of product after you have provided all the scientific support and AskFSIS? No, I believe they have no standing based on the information provided. However, the NR remains valid as the conditions prove that the SSOPs are insufficient to prevent insanitary conditions, and the cited regulations supports that conclusion
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Assuming this is a walk-in oven with an attached wood smoker, I have seen over 50 similar smokers, and only one had excessive black buildup of creosote, which was at a non-inspected smoking facility. The other ovens were nearly spotless, even after smoking products for 18 hours with continuous back-to-back operation. From my observations, such a buildup of creosote is a result of inadequate cleaning frequency. The regulation clearly states that "facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product." This buildup indicates that the frequency of sanitation is inadequate and needs to be increased in the SSOP’s.
Now, let's address how you can resolve this issue using the regulations. Corrective actions for SSOP are cited in 9 CFR 416.15(b): “Corrective actions include procedures to ensure appropriate disposition of product(s) that may be contaminated, restore sanitary conditions, and prevent the recurrence of direct contamination or adulteration of product(s), including appropriate reevaluation and modification of the Sanitation SOP's and the procedures specified therein or appropriate improvements in the execution of the Sanitation SOP's or the procedures specified therein.”
- Disposition of products that may be contaminated:
Refer to your AskFSIS statement which clearly indicates that creosote is not a contaminant; thus, the product is not considered contaminated, thus, does not need to be disposed. Next…
- Restore sanitary conditions:
Thoroughly clean the smokers and/or replace the pipes, then show the inspector. Next…
- Prevent recurrence of direct contamination or adulteration of product, including reevaluation of SSOP:
Your AskFSIS confirms there is no contamination issue, but does not address "adulterated." According to 9 CFR 301.2, the term "adulterated" has several meanings, but the relevant one here is: “(4) If it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” Once again, the AskFSIS states that creosote is not a contaminant. The fix? Increase the sanitation frequency of the smokers to satisfy the recurrence prevention aspect of the corrective actions.