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Are recalls changing in number, scope or focus? There seems to have been a continued run on recalls during 2018 along with some high-profile outbreaks that have challenged both our public health system and regulatory structure and process. So, we thought we would look at what is going on with recalls using the excellent Stericycle summary that is published each quarter. Recall reports are issued every quarter, and every quarter the same cause seems to top the list: undeclared allergens. But an entirely different story is detected when one assesses recalls by number of units recalled rather than by number of recalls. This was vastly evident in the 2018 Q2 recall index as compiled by Stericycle in which bacterial contamination was the cause for 99.2% of all FDA recalls, based on units recalled, with undeclared allergens making up only 0.4% of all units. In fact, if one looks at all quarters since the beginning of 2017, bacterial contamination was the cause for 44.1% of recalls by units with undeclared allergens making up only 27.3%. Additionally, there was an overall increase over Q1 in both the number of recalls (7%) and the number of units recalled for which there were more than 20 times as many as Q1. 99.2% is an awfully high percentage for bacterial contamination. While we do need to put it into the perspective that a large portion of that was related to the Rose Acres shell eggs recall due to the potential to have been contaminated with Salmonella, this still leaves a large number of recalls conducted for bacterial contamination. What can be hoped from this figure is that environmental monitoring programs (EMP) are successfully detecting bacteria and product is being recalled out of an abundance of caution for potential contamination and thus avoiding illness. Even if that is the case, however, it means that these environmental control programs (ECP) need to be beefed up. Monitoring for contamination is one thing – preventing and protecting against it is another. In case you missed it, we discussed EMP and ECP in last week’s newsletter, Foreign Facility Issues Provide Lessons Learned in Environmental Controls for Lm. While that article used foreign facilities as examples (as shown by its title), it is evident that there are a number of domestic facilities from which we can learn lessons as well. Food Recall Numbers vs. Units. The Q2 analysis brings up another interesting aspect of recall calculations. We often look at causes by number of recalls because a single large recall can vastly sway the number of units recalled in a quarter. This was, indeed, the case in Q2 2018 in which more than 200 million eggs were recalled. But, if you really think about it, which has the greater potential to impact public health? Look at it this way: In Q2 2018, there were 147 food recalls consisting of 212.8 million food units. Compare that to Q1 which had 138 recalls of 7.5 million food units. The number of recalls is not that much different, but the number of potentially impacted food units is incredibly vast. Because food units are the actual number of food items that could be consumed, thus the number of people who could be impacted (at a minimum), it actually is the number of greater significance in terms of potential exposure in the community. Thus, while there was an increase of only 10 recalls in Q2, there was the potential of impacting 205.3 million more people. In fact, as is shown in the table below, every quarter in 2017 had more recalls, but at least 100 million fewer units recalled. It poses some interesting food for thought. Perhaps we should reassess how we think about recalls in relation to risks? To end on a more positive note and give a few kudos to industry: Even with the increases and the excessively high number of units impacted this year, 2018 has the two lowest number of recalls over the last two years. Hopefully this means that food companies are working harder to reduce both bacterial contamination and undeclared allergens, as well as all other recall causes. But, as noted above, recalls do not tell the whole story. The last four months have been plagued by two very large and complex produce outbreaks due to E. coli O157:H7 and Cyclospora, neither of which has resulted in anything other than minor recalls. As we all know, food safety is multifaceted, and while we think recall data can be very informative it is, of course, only part of the story and is obviously a reaction to a situation. TAG is always emphasizing prevention. and this is another opportunity to do that in relation to the high level of “microbiological problems” as evidence by both the large outbreaks and the recall statistics discussed above. 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. Learn more at: www.AchesonGroup.com

Q2 Recall Analysis Fuels New Food for Thought