In June 2016, FDA received an “early alert” memorandum from the Office of the Inspector General (OIG) on its lack of an efficient, effective recall-initiation process. A year and a half later – despite the Agency’s subsequent push on firms for recall actions – the final report from OIG shows little improvement, as depicted (once again) by its very title: “The Food and Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply.” OIG’s review was initiated to determine whether FDA was using its new mandatory-recall authorities given by FSMA in “fulfilling its responsibility in safeguarding the Nation’s food supply now that it has mandatory recall authority.” OIG focused specifically on FDA’s oversight of firms’ initiation of food recalls, monitoring of firm-initiated recalls, and maintenance of food-recall data in the electronic recall data system. Its findings? “FDA did not always have an efficient and effective food-recall process that ensured the safety of the Nation’s food supply.” Specifically, OIG found that FDA could not always ensure that firms initiated recalls promptly and it did not always evaluate health hazards in a timely manner, issue audit check assignments at the appropriate level, complete audit checks in accordance with its procedures,collect timely and complete status reports from firms that have issued recalls, track key recall data in the RES, and maintain accurate recall data in the RES. Food recalls were not always initiated promptly because FDA does not have adequate procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls. FDA’s monitoring of recalls was not always adequate because FDA staff had insufficient oversight to ensure that the assignment was at the appropriate level and FDA obtained incomplete or inaccurate consignee information from firms initiating recalls. FDA lacked adequate procedures to collect timely and complete status reports from these firms because the procedures did not require staff to request status reports at the time the recall was initiated. The RES contained deficient recall information because it did not track all information necessary for FDA to effectively monitor recall activities and assess the timeliness of recalls; the RES also contained inaccurate data. While FDA agreed that it needs to help ensure the quick initiation of recalls, it stated that it has established procedures for improvement, such as SCORE, a new quality system audit process, a plan to provide early notice to the public, and more guidance to staff. However, the report then includes some back-and-forth comments between FDA and OIG on the accuracy of the time it took for recall initiation. So, what does all this mean for the food industry? Essentially the same impact as we saw occur from the early alert – “The result of that was swift and significant with the Agency pushing firms hard for recall actions.” – with the heat turned up even higher this time. From the 14 recommendations that OIG made for FDA, it seems that the primary impact on food facilities is likely to be increased monitoring and documentation with a goal of decreasing the time for recall initiation. That is, along with other internal agency improvements, it is recommended that FDA ensure that: recall audit check status updates and reports are completed. status reports are requested at the initiation of the recall and follow up conducted with firms that do not provide timely or complete status reports. performance measures be established and monitored for the amount of time between the date FDA learns of a potentially hazardous product and the date a firm initiates a voluntary recall, with operating procedures refined as needed. In our “8 for ’18” predictions of last week, we stated that we expect to see full supply chains to continue to be affected by recalls as in 2017. From this recent OIG report, the difference will likely be that the chain will be more quickly and thoroughly affected, with FDA increasing its “requests” for recalls of any and all facilities and suppliers they see as potentially implicated – and mandating those that don’t respond quickly enough. And FDA keeping a close eye on facility recall actions and documentation thereof. As has often been said since the implementation of FSMA – If it’s not in writing, it didn’t happen. One may wonder why FDA is falling short in the OIG’s eyes on recalls. One reason, in my view, is that the Agency does not have enough people to move as fast as it needs to for recalls. The Agency has to follow a due process and that means spending time figuring out what is an appropriate course of action for initiating a recall. The Agency could move a whole lot faster with testing. The time between taking swabs on food product during an inspection and the final result is painfully long at times. This results in unnecessary delays for protecting the public and sometimes puts food companies in a tough position while they hold large amounts of product. While the upside is, of course, better protection for consumers when a product or ingredient is contaminated, the downside could be the quick recall of “potentially” implicated product, later found to not have been the actual contamination point. Thus, food companies should push back if the request for a recall is felt to be inappropriate. A current question is whether there should there have been, for example, a recall on romaine lettuce recently, even though federal public health officials say there’s not enough proof to pinpoint it as the source? We need to safeguard against unnecessary recalls and, at the same time, move necessary recalls along a whole lot faster. Money, skills, technology and leadership would be a good set of ingredients to get this right. I will leave it up to FDA to look internally and figure out what it is lacking and how to make the case to solve the deficiency. 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
