There is no more perfect image of summer idyll: a blanket on a grassy knoll in a city park, the sunlight filtering through the leaves of an old oak tree as you chase rivulets of melting ice cream down a perfect sugar cone. For most of us, the summer picnic is a treasured childhood memory that invokes sensations of happiness, comfort, and pleasure.
But not so much if the scoop of Rocky Road, Caramel Swirl, or Darkest Chocolate brings with it to the picnic an uninvited guest. Listeria: even the name conjures up a not unreasonable fear. Fever, muscle aches, headache, stiff neck, nausea, diarrhea, and convulsions are all attendant symptoms, depending on the severity of this infectious little bacterium. And, in pregnant women, contact with Listeria monocytogenes (to give it its full name) can result in miscarriage or stillbirth.(1)
Naturally occurring in soil and water, L. monocytogenes, can be found in processed foods, soft cheeses, unpasteurized milk, and on the soil of some vegetables. And, as Jeni Britton Bauer of ‘Jeni’s Splendid Ice Cream,’ an artisanal ice cream manufacturer based in Ohio discovered much to her chagrin, it’s often to be found in your kitchen.
In April 2015, the company received notification that a random sampling of their Dark Chocolate ice cream had tested positive for listeria. Along with that single pint, the Nebraska Department of Agriculture tested many others and also conducted sample tests of surfaces in Jeni’s production kitchen. The facility was shut down and a recall of an estimated 535,000 pounds of product was initiated. Although the problem affected primarily the ‘pint market’ (the ice cream sold by the pint in stores), all 23 of Jeni’s scoop shops were also shuttered. The whole recall cost somewhere in the region of $2.5million, and that was just the opening gambit.
Production resumed in mid-May 2015 but listeria was found again in June and the kitchen went dark once more. Sample swabs taken from the floor tested positive but as Jeni herself was quick to point out “No Listeria got into any ice cream we served. There was no Listeria contamination or outbreak because our protocols and testing prevented it.”(2) Moreover, the company argued that frequent product testing would be an adequate safeguard given that “the periodic detection of Listeria on non-food contact surfaces is not in any way abnormal in the industry or indicative of an ‘outbreak’ of Listeria.”(3)
Be that as it may, the company did institute what seemed to be a comprehensive contamination control policy. Hiring a seasoned microbiologist from the Ohio State University to head up a quality leadership program, it dived headfirst into an exhaustive regime of conducting almost 200 swabs per day for the sixty days following the initial detection of contamination. During that time, the company alleges that no occurrences of L. monocytogenes were detected in food-contact areas or in Zone 2, the area immediately surrounding food contact areas. However…
In January 2016, inspectors from the U.S. Food and Drug Administration (FDA) once again visited the manufacturing facility and found their appetite for the frozen treat severely diminished. Not only was the listeria bacterium found again but, after the FDA performed Whole Genome Sequencing (WGS) on the samples, it determined that the most recent ones were genetically identical to earlier samples. In other words, the bacterium strain found in April and in May and later in June of 2015 had never been eradicated.
The genetic continuance of the pathogen clearly indicates that whatever measures the company undertook with its ‘aggressive Listeria control program with an on-going seek-and-destroy mission: find, eliminate, and prevent the growth and establishment of Listeria’ had utterly failed.(4) And then there is the matter of the supplemental citations for observed violations of Current Good Manufacturing Practice (cGMP)…
In a warning letter dated August 9, 2016, the FDA noted that standard operating procedures (SOPs) for Traffic Flow at the Jeni’s Splendid Ice Cream manufacturing facility left much to be desired. Actively promoting surface-to-surface cross contamination, an employee was observed ‘placing “skinned” bags of sugar on a cart in the prep room, then moving these bags beside a prep table where they were picked up and manually poured from the bags into clear plastic containers such that the outside of the sugar bags came into direct contact with the inner food contact surface of the plastic containers.’(5) The point of contamination in this incident is the contact between the outside of the sugar bag and the inside of the holding container. Could an employee be forgiven for such an apparently minor infraction? Sure…if the exact same problem hadn’t already been called out in a previous inspection. According to the FDA warning letter, this was ‘a repeat observation from our April 2015 inspection, where a bag of cocoa powder was observed being handled by an employee in a similar manner.’(6)
So, this is the second instance of the same violation, which begs the question: Do inspectors from the FDA have to be physically present to prevent such contamination from occurring? And the answer to that tongue-in-cheek question is…no. Let us consider the Food Safety Modernization Act (FMSA), signed into law by President Obama in 2011. According to the FDA, this act – ‘the most sweeping reform of our food safety laws in more than 70 years’ – was drawn up to protect our food supply by shifting the focus from relying on random inspections to encouraging active prevention on the part of the manufacturers.(7) And with around 48 million Americans – that’s 1 in 6 of us – becoming sickened by our food annually, contamination control in food production is critically important. As the old saying goes, prevention is better than cure, and effective prevention is often about education: knowing the correct SOPs and using the correct tools.
One of the key requirements of the act, along with enhanced oversight and management of preventive controls, is the updating and clarification of cGMPs, specifically with regard to the education of employees. Although previously nonbinding, in the wake of FSMA, provisions such as employees having ‘the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food’ are now binding.(8) So there really is no excuse for food technicians introducing cross contamination during ingredient transfer.
The cost of this latest missive from the FDA to Jeni’s Splendid Ice Creams is hard to assess. The company has been warned that the letter was not all-inclusive in outlining violations and that the bill for re-inspections to ensure compliance would not be the burden of the taxpayer. And these expenses can be sizable: ‘Re-inspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]’(9)
And it’s no secret that Jeni’s is unlikely to be the only or last company to face these contamination control challenges. Most manufacturers know they’re fighting an on-going battle to make their facilities the safest and cleanest they can possibly be. But in the event that they need help in getting ahead of contamination, and in compliance with the FDA, proactively – and that is the whole purpose of the law – the best companies also know they can have Berkshire on their side.
Do you have a comment on the FDAs FSMA? Thoughts on preventing surface-to-surface contamination? Or just hungering for more? Leave us a comment!