FSIS identified that inadequate validation of the Hazard Analysis Critical Control Point (HACCP) system design may have led to the production of adulterated product.
The agency said there are two elements to validation: the scientific or technical support for the HACCP system design (design) and the initial practical in-plant demonstration proving the HACCP system can perform as expected (execution).
14 cases were reported with illness onset ranging from 10 January to 15 February, according to a final update from the Centers for Disease Control and Prevention (CDC).
It led to Palmyra Bologna Company, of Palmyra, Pennsylvania, recalling 23,000 pounds of Lebanon bologna products, which are similar in appearance to salami.
FSIS found critical operational parameters included pH, time, temperature, relative humidity, equipment settings or calibration, and spatial configuration.
In the process at the establishment, raw Lebanon bologna mix was compacted in 52 to 119mm diameter permeable casings that were placed in a large smokehouse fitted with a single source of heat and humidity that was not well-controlled.
However, in supporting documentation identified by the firm to represent a commercial process for Lebanon bologna, raw Lebanon bologna mix was compacted in smaller 27mm diameter impermeable sealed glass tubes that were immersed in a well-controlled water bath.
“The difference in the diameter and type of casing material likely led to a lower reduction in foodborne pathogens of concern in the actual process than what was demonstrated in the supporting documentation.
“If the diameter of the establishment’s product is larger than that of the product used in the supporting documentation, it is possible that the product core will take longer to reach the desired temperature and pH.”
The guidance added that taking a longer time than expected to reach the desired temperature and pH may lead to a lower level of pathogen reduction.
It also made changes to the recommended log reduction for Listeria monocytogenesto be consistent with other FSIS guidance documents.