Case Studies - Allergen Root Cause Analyses

An article in Food Safety Magazine, titled Anatomy of Food Allergen Recalls,  sheds light on the root cause of six different allergen-related recalls.  Key points from that article:

Egg residue in pasta product - Line spillover form one product to another

• "The pasta in this product was obtained from a pasta supplier. The manufacturer of the implicated product decided to conduct an inspection of the pasta supplier's facility. In the course of that inspection, a location was discovered where a line transporting egg noodles crossed over a line transporting this company's non-egg product. The inspector was able to discern that egg noodles would periodically drop from the noodle line into the non-egg pasta. Subsequently, a tote of the finished non-egg pasta ingredient was found to contain several egg noodles on visual inspection. Since these noodles were discrete particulates, they were not likely present in every container of the manufacturer's retorted product. Thus, the presence of egg evaded detection when only a few containers were selected for egg analysis."
• "The line crossover was identified as the root cause, and a shield was placed over the non-egg line to prevent egg noodles from dropping into the non-egg pasta."

Peanut in Chocolate Ice Cream - Rework Issue

• "A review of rework records at the manufacturing facility clearly and astonishingly showed that peanut butter swirl ice cream had been incorporated into the chocolate ice cream. The use of rework as an ingredient explains why consistent and moderately high levels of peanut residues were detected in the chocolate ice cream. Further investigation revealed that a key employee had interpreted the like-into-like as permitting the use of any flavor in rework that would not affect the color or flavor of the chocolate ice cream."
• "The use of peanut-containing rework was identified as the root cause of this recall. Corrective actions included more specific and detailed employee training on preventive allergen controls and implementation of a new rework policy (exact-into-exact), where rework was only allowed to be incorporated into the same SKU of product from which it had been generated."

Peanut in Spice Mix - Poor Supplier

• "Due to the very high levels of peanut found in the cumin, the manufacturer suspected intentional adulteration; however, such allegations are difficult to prove. Other spice mix companies that were customers of the same Turkish supplier were also found to have received and distributed seasoning mixes and ground cumin with high levels of undeclared peanut. Initially, no consumer complaints were received, but several complaints ultimately were linked to products associated with the implicated cumin. Hundreds of product recalls ensued."
• "The root cause was the presence of undeclared peanut in cumin obtained from a specific supplier. The corrective action was the cessation of the import of ground cumin from the particular Turkish supplier. Some affected companies began to source ground cumin from U.S. suppliers that imported whole cumin seeds and ground the spice in U.S. facilities."

Cumin with peanut - Farming practices

• "The cumin-growing region of India is also home to peanut farms. An observation was made by inspectors in India that many of these farmers were reusing burlap bags that may have been previously used for peanuts or peanut meal. Peanuts in India are sometimes processed into peanut oil, leaving behind peanut meal that farmers might transport in burlap bags to feed cows; those same bags might be later used to carry cumin."
• "This root cause was never fully documented, but several spice manufacturers began supplying the farmers with new burlap bags. This practice coincided with fewer cumin or cumin-containing spice mixes testing positive for peanut residues."

Undeclared Almond in Paprika - Testing failure

• "In the EU, retail paprika samples were recalled for the presence of undeclared almond. The source of the ground paprika was a Middle Eastern supplier. This supplier had no almonds in its facility, although the supplier indicated that it used shared equipment to grind both paprika and mahaleb, a popular Middle Eastern spice made from the pits of a variety of mahaleb cherries."
• "Subsequent analysis revealed that mahaleb residues would test positive in the almond ELISA methods, and mass spectrometric analysis revealed that the residues in the ground paprika had come from cherry pits and not almonds. Canada rescinded its recalls for undeclared almond in paprika. Allergen ELISA methods are typically quite specific; however, in the case of botanical cousins such as almond and mahaleb cherries, cross-reactivity is possible."
• "The root cause of these recalls was a faulty analytical method. The corrective action involved the use of a more specific analytical method to distinguish between almonds and cherry pits. Due to the close relationship between almonds and mahaleb cherries, the proteins from these two foods are likely to be highly homologous, suggesting that ingestion of mahaleb might cause reactions in almond-allergic individuals."

Cereal with undeclared milk - Overspray transfers allergens

• "A breakfast cereal manufacturer used shared processing and packaging equipment for the processing of one cereal product with milk and another with no milk-derived ingredients."
• "The manufacturer realized that droplets from the wet washing procedure were transferring onto the roll stock plastic packaging used as the inner liner for the boxes of cereal. Corrective actions involved moving the packaging equipment further away and shrouding it during allergen cleaning."