You are an IIC at a large three-line NELS poultry plant with TSP on-line reprocessing.

Shortly after start-up an inspector on line two requests that you look at a couple of birds he/she had the helper take off of the line. You notice a couple of small black specks on the legs of the carcasses. After you question this inspector, and all of the other inspectors, you perform some verification of your own and determine that this is a very infrequent occurrence, isolated to line two, and that the bird washers further down the line seem to be removing the specks. You determine this to be potential economic adulteration but that the product is meeting Finished Product Standards (FPS).

Several hours later, one of the GS-08 floor inspector informs you that he/she found "several small smearable black specks" on four of the ten birds while performing a pre-chill FPS test on line two. He/she determined that this substance appeared to be falling off of the rails and onto the carcasses. He/she also informs you that the FPS test passed and therefore the plant did not seem to be worried about it.

Moments later, the other GS-08 floor inspector informs you that the line inspectors on line two had notified her/him that "the birds were covered with a powdery black substance" and that they wanted to see you.

You go out into the plant to investigate the line inspectors’ concern. You determine that approximately 45% of the birds have varying degrees of a powdery, smearable black substance on them. You look up at the rails and notice a build-up of this same substance on the rails and the chain’s trolley wheels.

• At this point you invoke the "Rules of Practice" according to [9 CFR 500.2(a)(1)&(2)] (This is a "Regulatory Control Action" due to insanitary conditions/practices and /or product adulteration). You stop the line and place a US Reject Tag on the start switch.
• You immediately inform a member of plant management of their failure to meet [9 CFR 416.4(d)], which states that product must be protected from adulteration during processing and handling. You also inform them that due to the insanitary condition you are taking a regulatory control action and stopping the line until sanitary conditions have been restored.
• You do not accept the plant’s arguments that pre-chill tests are passing and the "birds are passing through TSP, anyway."

At this point you review the plant’s FPS and SSOP records:

• The plant’s pre- and post-chill FPS records show higher than normal levels of extraneous material.
• The plant’s pre-operational SSOP records show, that in an effort to reduce some minor rust build-up on the line two rail the sanitation crew had performed "an extra heavy foaming of the rail with an approved cleaner, followed by a thorough rinsing with water." This in turn had led the maintenance department to "oil the line with an approved lubricant."
• The operational SSOP records show that the past three hourly operational sanitation checks indicated that there was a problem with a black powdery build-up on the rails and trolley wheels and that "this same substance was falling onto the chickens." The plant had responded with short skips in production in order to "wipe the rails with rags soaked in an approved lubricant." The last entry indicated that the plant planned to perform a more thorough wiping at lunch (which was still approximately two hours away at that point). The records also indicated that any affected product was appropriately reconditioned.

After completing your records review, you inspect some product in the cut-up department:

• You observe this same black substance on product being placed into packages going to the cooler, labeled and ready to ship. You place a US Retained tag on the affected product and inform the appropriate supervisor that the product is on hold.

Finally, you inform plant management of the following:

• That they had seemingly performed all operational SSOP checks according to their procedures, but they had failed to take proper corrective actions according to [9 CFR 416.15(a)], when it was determined that the implementation of the sanitation SOP’s had failed to prevent direct product contamination or adulteration of product.
• That conditions were such that adulterated product was repeatedly being produced and this same product was being packaged and ready to ship.
• That they would have to meet the "Corrective Actions" requirements of [9 CFR 416.15(b)], to include:
• Procedures to ensure appropriate disposition of product(s) that may be contaminated.
• Restore sanitary conditions.
• Prevent the recurrence of direct contamination or adulteration of product(s).
• Appropriately reevaluate and modify the SSOP’s specified procedures and/or make improvements in the implementation of the execution of the procedures specified therein.

You go to your office to document the non-compliance on an NR and to await the establishment’s response.

Note:

• The original findings were infrequent and isolated. As such, they fell under the heading of potential economic adulteration. An NR would only be documented it there was an FPS failure. The NR would be under the 04C04 code. Only later, after several hours of the trolley wheels’ friction causing this black substance (blackened, flaking lubricant) to build up, did the problem become bad enough to warrant calling it an SSOP failure and taking the actions outlined.
• This would not be considered a food safety non-compliance under HACCP ("03J" code) and [9 CFR 417]. The lubricant the plant used was classified as safe for incidental contact and the plant has the appropriate documentation to guarantee the substance’s safety.

For IKE related questions, send mail to ike@fsis.usda.gov