Almark Foods  and the FDA need to explain why positive product tests and illnesses in 2017 did not stop positive product tests and illnesses in 2019.

As of December 17, 2019, a total of seven people infected with the outbreak strain of Listeria monocytogenes have been reported from five states – Texas, Florida, South Carolina, Pennsylvania and Maine.

Listeria specimens from ill people were collected from April 10, 2017, to November 12, 2019. Ill people range in age from less than 1 to 82 years, with a median age of 75. Seventy-one percent of ill people are male. Of six ill people with information available, four hospitalizations have been reported. One death has been reported from Texas. One illness was reported in a newborn who was infected with Listeria while the mother was pregnant, but the newborn survived.

Epidemiologic and laboratory evidence indicates that bulk hard-boiled eggs produced by Almark Foods of Gainesville, Georgia, are a likely source of this outbreak.

Additionally, based on whole-genome sequencing, the Listeria monocytogenes found in environmental samples collected at the firm’s processing facility during an FDA inspection conducted in February 2019 is a genetic match to the outbreak strain.  FDA laboratory analysis of the environmental sample collected February 6, 2019, confirmed that two (2) environmental swabs were positive for L. monocytogenes.  The two swabs were collected from the peeling room in the following locations:

• One (1) environmental swab was collected from the peeling room floor drain near (b)(4).
• One (1) environmental swab was collected from the egg counter entrance and stainless-steel area at the end of the conveyor belt. This location is a food contact surface.

Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from the FDA environmental sample collected on February 6, 2019.  WGS analysis of food-borne pathogens provides high-resolution data, which can be used to infer the evolutionary relationship (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness.  The WGS phylogenetic analysis established that there is at least one (1) strain of L. monocytogenes present in your facility and that strain contains both of the referenced isolates.  Specifically, WGS analysis of the strain revealed that the two (2) isolates, collected from two (2) different zone locations, are genetically identical to each other, which suggests possible cross-contamination between the locations.  Further, the WGS analysis of the strain also showed that the isolates are genetically identical to 2 cases of human illness dating back to 2017.

According to the FDA, this outbreak strain was found during environmental sampling in 2017 of one other Almark food facility. That facility is not currently handling food and ceased operation in 2018.

On December 20, 2019, Almark Foods recalled and suspended production of hard-boiled and peeled eggs in pails due to the potential for contamination with Listeria monocytogenes. These hard-boiled and peeled eggs were sold in pails under the following names: Rainbow Select Hard-cooked Eggs, Rainbow Select Hard-cooked Eggs in Vinegar, Nic’s Salad Hard-boiled Eggs, Almark Hard-cooked Eggs, and Sutherland Select Hard-cooked Eggs.