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TAG August 28, 2019 0 Comments

In 2009, FDA established the Reportable Food Registry (RFR) to enable the agency to track patterns of adulteration in food and thereby better target its food inspections. The RFR is an electronic portal for industry to notify FDA when there is a “reportable food,” defined as a food with a reasonable probability that it will cause serious adverse health consequences or death. The definition of a reportable food is essentially identical to that of a Class I recall. That is, A reportable food is one for which “there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals.” A Class I recall is required for a food for which “there is significant and immediate danger of death or other serious injury from the use of the product.” As a result, a reportable food is typically also the subject of a Class I recall. But while recall reporting is submitted by each company in its own format, reportable foods require specific reporting parameters. The agency has issued guidance specifying the information it recommends that firms provide in the event of a recall and that which must be provided in the RFR. As you may expect from the above definitions, a review of the two shows a great deal of overlap. In spite of this, FDA handles the related events separately, and has not modernized its RFR system to allow firms to electronically transfer their information to FDA. So, what does that mean to a firm conducting a recall, providing recall information to FDA, and then submitting much of the same information to the RFR? Unfortunately, it means that firms – including those who electronically gather and process recall information – have to handle these two processes separately to follow FDA guidance and comply with the reporting requirements. As any firm that has gone through a Class I recall knows, this is an extraordinarily busy and frantic time, and time is of the essence. The additional time required under FDA’s current system places a burden on firms at a time they can least afford it. This is not an insignificant industry burden, as nearly one in three food recalls are for reportable foods. From 2010 to 2014, an average of 684 human and pet food recalls were reported each year in the annual FDA CFSAN and CVM enforcement statistics. Of these, an average of 216 per year also required an RFR report. Not only is this a burden on industry, it raises public health concerns. When data needs to undergo double entry, it increases the likelihood of errors being introduced and delays reporting. For the sake of both consumers and industry, now is the time for FDA to modernize its RFR system. Fortunately, I believe FDA is heading in this direction. The agency’s recent announcement of a “new era of smarter food safety” is an opportunity for it to harmonize its RFR and recall processes and work with industry to optimize efficiency. Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, has made clear that he wants to find ways for government and industry to work together more effectively, more collaboratively, and using new technologies. This would be an easy and important fix that would gain a lot of good will and serve the American people. 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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