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Addressing the Romaine Challenges – Are We Heading to Another Thanksgiving Day Romaine Massacre?

As I write this week’s newsletter, there is yet another announcement of romaine lettuce being linked to E. coli illnesses, this time in Maryland. But at the same time there is also an E. coli outbreak happening in Wisconsin, that as of the time of writing the Wisconsin cases have not been linked to anything definitive. If the Wisconsin outbreak turns out to be due to romaine then we are setting up the exact same scenario as last November when FDA and CDC told American consumers to “avoid all romaine lettuce.” All of this comes on the heels of a smaller outbreak in the August-September time frame on top of the outbreaks in 2017 and 2018. As of today FDA has not made any sweeping romaine-focused announcement, but they have embarked on a new “small, focused assignment to collect samples of raw agricultural commodity (RAC) romaine lettuce to test for Salmonella spp. and pathogenic Escherichia coli.” The agency started the testing this month and will be continuing it for the next year; Salmonella is being included because it is commonly associated with fresh produce and was associated with a 2012 outbreak in romaine. There’s an old saying in the food industry that you can’t test your way to food safety. That’s not to say that testing can’t be an important part of any food safety program; but as a reactive vs. preventive act, it’s not a good way to control risk. FDA’s testing of RAC romaine, prior to processing or commingling, should enable quick traceback to its point of origin and may keep a contaminated lot from reaching consumers, but it is not getting to the root cause or providing real risk management. In many cases, it is even likely to be a duplication of efforts as romaine producers – particularly those confirmed or suspected as associated with outbreaks which FDA is prioritizing – are likely conducting such testing themselves. I’m not saying that the assignment is without merit for public health – if a pathogen is detected in the testing, the agency plans to perform whole genome sequencing (WGS) to determine its virulence and any relation to isolates causing human illness. Additionally, the testing is intended to help FDA, CDC and state public health agencies “identify sources of contamination and factors that may be contributing to them, so that they can be addressed.” So there is some intention in FDA’s sampling, but it seems to me that a year-long testing, for which a report won’t be made until late 2020 at the earliest, is not the best way to control a risk that continues to be at issue. Particularly since the agency already conducted a similar assignment testing romaine lettuce grown in the Yuma, AZ, agricultural region for E. coli (STEC) and Salmonella spp. following the Spring 2018 outbreak linked to romaine lettuce for which it just released its findings in August, and, for which this is, presumably, the follow up. FDA plans to test a total of 270 samples, each of which will consist of 10 subsamples since microbial hazards may not be uniformly present. If one subsample tests positive, FDA will regard the entire sample as positive. So, what is a producer to do if FDA arrives unannounced and takes samples that are at the tail end of a harvest lot? In my scenario, the rest of the lot has already been processed and is in the flume, being bagged or boxed waiting for shipment. All of the product from that lot is potentially suspect – so the only sensible course of action is for the processor to hold all of it. This will put both economic and business pressure on the producer – which is part of the FDA message around the urgency of addressing the issues with romaine. With such a target on the backs of the produce industry – again, perhaps FDA sampling will be the stick that prods the industry as a whole to increase their food safety efforts – particularly with the agency noting that it “understands that some firms may opt to hold product pending notification of test results” which it states as generally occurring within four days, though WGS and “cannot-rule-out” initial findings could take an additional seven days for final results. And, if a pathogen is detected, compliance and enforcement action will be based on the “available evidence and the adequacy of the firm’s response to prevent future contamination,” including actions to correct and prevent violations and to remove the food from the market. I have no doubt that FDA will use every enforcement action in its repertoire if a positive result is found. The testing program and the continuing outbreaks are putting the produce industry and FDA under huge pressure to do something different – the key question is what? The FDA testing program is not designed to offer high levels of consumer safety for all romaine, but more to see what can be found at the farm level and to send a solid message to the industry. In my opinion, more testing is not the answer even though it may feel good! We will never prevent the “overflying bird” or test our way to safety, and current testing programs are already designed to find major contamination. Can we do more on the farms? Can we do more with water supply? Can we do more with product tracking from field to consumer? Can we do other things? Today when one grower cuts corners, the whole industry suffers – this has to change. And while this may be food safety heresy, I have to wonder whether it is time in the produce industry for food safety to become a competitive advantage. My fear is that the CDC and FDA may advise consumers in the coming days to avoid consuming romaine, which will again throw a whole commodity under the bus when it is likely a single grower that is responsible. What we have been doing so far is not working – it is time for some real change. 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.


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