Directing the Storm with Environmental Monitoring
Updated: Nov 22, 2018
The March 30, 2016, headline in Virginia's Progress-Index newspaper raved "Sabra and hummus take the nation by storm." Seven months later, national headlines were to rage about a different sort of stormsat the company's facility – the findings from an FDA inspection which not only "revealed 27 swabs of the processing environment that contained Listeria monocytogenes," but also showed, through pulse-field gel electrophoresis (PFGE), that one of the strains matched a strain found in a retail product sample collected in 2015, "indicating this strain of Listeria monocytogenes may be persistent in the production environment." The resulting voluntary recall not only included a number of the company's flavors of hummus, but also impacted multiple downstream products in which the hummus had been used.
A Nov. 20 letter from the CEO on Sabra's Recall Notice webpage stated: "We are disappointed to share the news of a voluntary recall with the Sabra community today. We’re recalling this product out of an abundance of caution after finding Listeria monocytogenes at the manufacturing facility, but not in tested finished product."
From our perspective at TAG we are not picking on Sabra but rather want to use this recent situation to bring our readers focus on the critical importance of having a really solid environmental control program. The numbers of recalls and outbreaks linked to environmental contamination over the last few years is significant. FDA is more focused on your environmental monitoring program now than they have ever been in the past.
FDA is looking, and looking hard, in the environment for pathogens. The Agency is testing all zones and when they find a positive (Salmonella or Listeria monocytogenes) they are doing Whole Genome Sequencing. If there is a match to a strain they have found in your plant previously (or in a downstream product) – watch out! You will potentially be looking at a very large recall, irrespective of whether there is any evidence of human illness.
While we also know from the CEO letter that Sabra had a procedure for "testing finished product from the production line every two minutes for pathogens including listeria," and that it "implemented a thorough and extensive factory-wide cleaning and sanitation procedure" after the FDA inspection, we don't know the extent to which the plant had an environmental testing and control program prior to the inspection and how good that program was. But another very clear message from this incident is that testing product every two minutes will not get you off the hook from a recall. Such testing is costly and clearly not a robust way to control risks. I have said many times that you can't test your way to safety with finished product testing, but somehow many in the food industry still want to do it as a primary control system. Maybe this recent recall will be a wake up to those who have this false sense of security around finished product testing.
We do also know that the company is working "very closely with internal and external food safety experts to identify any additional steps we can take to even further enhance our efforts." And, we'd be willing to lay odds that those experts are recommending a more intensive environmental monitoring program. That would certainly be a key recommendation I would make anyway, and it is most definitely a recommendation FDA would make …
considering it is a key element of FSMA's Preventive Controls rules. The key point here is: Know what is going on in your environment and fix it before FDA tells you what is going on!!
When a pathogen is detected in the environment, but not on finished product, companies frequently use the phraseology that they are implementing (or expanding) a voluntary recall "out of an abundance of caution." While this may help to soothe the minds of those who had already eaten product prior to knowing of the recall, it does not reduce the company's responsibility or liability should an illness come to light – particularly in these days of litigation, with food safety lawyers regularly posting recall notices on their websites and soliciting affected persons.
But what is also important to take from this is FDA's ability to analyze and connect strains of pathogens through whole genome sequencing or pulse-field gel electrophoresis and determine that a resident strain "may be persistent in the production environment." Such technologies are further increasing the risk for food facilities (and their executives as we discussed in earlier this year in What Does DOJ’s Increased Focus on Food Safety Mean to the Industry?). Not only can it link previous recalls (and any associated illnesses or even deaths) with a current pathogenic detection, it can indicate that the environmental monitoring program is not sufficient, and the facility not in compliance with FSMA.
Although the PC rule cites environmental monitoring as a possible verification activity “only required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system," FSMA’s Hazard Analysis Risk-Based Preventive Controls (HARPC) takes a holistic approach to risk management. That is, as I noted in a previous newsletter, viewing the entire plant operation as a single entity to determine and reduce any risks that require preventive controls. And this is exactly where environmental monitoring comes into play – what risks are inherent in the environment? How can these be controlled? One key answer is the cleanliness and sanitation of the environment – monitored through an environmental testing program to detect any potential risk.
Environmental monitoring as part of a solid environmental control program is a critical component of today's preventive approach to food safety. By helping you detect potential risk before it becomes a real risk – and before FDA detects it, it can help to keep a negative storm of media attention from moving in your direction as well as the massive economic consequences of large recalls.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com