Today the FDA declared that the latest Romaine Outbreak investigation has concluded and published its findings in the: “Investigation Summary: Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E. coli O157:H7”.
I want to join the chorus of many food safety professionals commending Commissioner Gottlieb and Deputy Commissioner Yiannas for their diligent efforts to conclude this investigation during a time period that included the most recent government shutdown!
The tl;dr (“too long – didn’t read” for those that don’t know all my abbreviations yet) from the statement is the focus on the root cause of the systems failure. I copy the relevant section in here (emphasis my own) because the explanation is well structured and highlights an important point I want to focus on: prevention.
Real-Time Verification for Preventive Controls
“As part of our investigation, we determined that the farm had a procedure in place to collect and test reservoir agricultural water for generic E. coli and to treat the agricultural water with a sanitizer before use. However, the investigation team noted the verification procedure records did not document that sufficient sanitizer was present to adequately reduce any pathogens present in the water when this water was used for direct contact with romaine lettuce at harvest, during postharvest handling, and to wash/rinse harvest equipment food contact surfaces. It’s important to note that the farm reported that it did not use water from the reservoir for the dilution of crop protection chemicals.”
Prevention and with it the real-time verification of the efficacy of these preventive controls is paramount and I strongly feel the FDA should use its platform to advocate for a heightened focus on this critical step in the risk mitigation cascade.
What this statement describes is a failure to continuously verify that the Preventive Controls required to control a biological, chemical (or nuclear) hazard that has been identified, are still working.
This type of failure is common because most preventive controls verification is done on a manual or at best semi-automated basis. That creates a failure mode (FM) and resultant effects, which we as engineers are taught to analyze and design a system for, that prevents this FM from occurring again.
The section of the statement that deals with the recommendations for the prevention of future outbreaks however focuses on reactive measures such as traceback capabilities. I do agree that tracebacks are critical for rapid containment and ultimately root cause analysis used for improvement, BUT it does not focus enough on prevention. The statement is shared below.
“The FDA continues to recommend that leafy green growers, buyer/shippers and retailers be able to trace product back to the specific source in real time and make information about the source, such as harvest date and standardized growing regions, readily available for consumers on either packaging or point of sale signs, or by other means. We’re pleased to see many companies in the leafy green industry take voluntary steps to quickly respond to our previous recommendations. We believe this is the best approach to be able to inform consumers should there be any future risks to public health.”
Food Recall Prevention is Key
Prevention – by its very nature – is always preferable to reaction, and it is possible to be more preventive today than before. Automation and integration of systems is key for that.
I will close by noting that the FDA did mention that: “We know more needs to be done and there is a shared sense of urgency around these efforts.”
We look forward to working with Commissioner Gottlieb and Deputy Commissioner Yiannis on hardening and modernizing the food system in a collaborative fashion!