In a previous post, we surveyed Best Practices for Food Recall Response & Prevention. As a follow up, in this post we take a deeper dive into the three recall classes: what distinguishes them from each other, illustrated by concrete examples. Then, after a brief “report card” on how well the Food and Drug Administration (FDA) has been handling the most urgent recalls (Class I), we’ll suggest a few ways companies can help the FDA minimize problems caused by recalls.
When there’s reason to believe that misbranded or adulterated products enter the market, the USDA’s Food and Safety Inspection Service (FSIS) Recall Management Division convenes its standing Recall Committee located within the FDA. Consisting of technical experts, scientists, field inspection managers, communications specialists, and enforcement personnel, the committee evaluates the available data and makes recommendations about the need for a recall. If the Committee recommends a recall, they classify it based on the relative adverse food safety risks.
A "Class I Recall" is the most urgent. It indicates a likely hazard situation in which there is a reasonable probability that consuming the contaminated food will cause health problems or even result in death. Examples of Class I recalls include confirmed cases of:
Of the nearly 3,000 food recalls reported by the FDA in 2017, 16.5% were Class I. In the case of a Class I Recall, the FDA develops an individual plan specific to the companies involved to ensure that the implicated items are trackable. The prime objective is to remove all contaminated food products from the market and consumer homes.
A "Class II Recall" is an intermediate threat. It indicates a potential hazard situation in which there is a remote probability of adverse health consequences that are usually temporary and medically reversible. Examples of a Class II Recall include:
A Class II Recall is preventative in nature and issued if there is no immediate danger of death or other serious injury linked to the product. the FDA works with firms to publicize the recall and to create a plan to pull the recalled items from the market as quickly as possible.
A "Class III Recall" is the least serious. It involves a food product that violates the FDA labeling or manufacturing laws with an unlikely probability of adverse health consequences. Examples of Class III Recalls include:
Similar to a Class III Recall, a Market Withdrawal occurs when a product has a minor violation that would not be subject to the FDA legal action. In this case, the firm removes the product from the market or corrects the violation. An example would be a suspicion of tampering with the product, without evidence of manufacturing or distribution problems.
A 2017 report from the Office of Inspector General (OIG) of the Department of Health and Human Services made some alarming accusations: in short, that the FDA did not always implement an efficient and effective Class I Recall process ensuring the safety of the nation’s food supply. The report identified deficiencies in the FDA’s oversight of recall initiation, monitoring of recalls, and the recall information captured and maintained in the FDA’s electronic recall data system, the Recall Enterprise System (RES).
Specifically, OIG claimed that the FDA could not always enforce that firms initiated recalls promptly. Furthermore, the FDA had insufficient oversight to ensure that the assignment was at the appropriate class level (i.e., Class I, the most urgent). Additionally, the FDA lacked adequate procedures to collect timely and complete status reports from firms.
In a Class I Recall involving various nut butter products contaminated with Salmonella, the FDA had been aware of the contamination for 161 days before the responsible firm agreed to recall its products. The agency then took an additional 41 working days to complete their evaluation. During this time lag, at least 14 people became ill from the Salmonella contamination.
Nut butters can become contaminated with Salmonella, which can lead to diarrhea, fever, chills, and abdominal pain.
In another example involving a series of recalls of various cheese products contaminated with Listeria monocytogenes, 81 days passed from the date the FDA became aware of the adulterated product and the date the firm had voluntarily recalled all affected products. During that time, the firm agreed with the FDA to suspend manufacturing and temporarily halt its distribution of cheese. The firm’s owner, however, despite knowing that the product had tested positive for Listeria, went ahead and processed, packaged and distributed multiple trays of contaminated cheese.
Cheese, which can be contaminated with and permit growth of Listeria, can lead to headache, stiff neck, confusion or changes in alertness.
In the report’s conclusion, OIG recommended that the FDA use its Strategic Coordinated Oversight of Recall Execution (SCORE) initiative to establish timeframes, expedite decision-making to move recall cases forward, and improve electronic recall data.
In response to the report, the FDA explained that delays in evaluating health hazards were caused by difficulties obtaining the information needed to make decisions about the severity of the health hazard presented by the product. Nevertheless, the agency agreed that it needs to help ensure recalls are initiated promptly in all circumstances and that it will initiate a new quality system audit process and a plan to provide early notice to the public and more guidance to staff.
Given the many potentially serious costs incurred by a Class I Recall, it is imperative for grocery sector personnel – from the C-suite to the store employees – to cooperate with the FDA requests immediately, provide complete and accurate digital data, and train all staff to ensure food safety.
For retailers especially, recalls present a particularly thorny situation. Although grocery stores are typically not at fault for product contamination, grocery staff are, nevertheless, tasked with a multitude of responsibilities. The food safety team or the public affairs department (or both) must collect information about the contaminated product, including the lot numbers, UPCs, distribution and shipping information.
Food That Sickened People in Outbreaks with a Single Known Source, 2009-2016. Source: https://www.cdc.gov/foodsafety/cdc-and-food-safety.html
Once management collects this information, they issue an internal recall notice that goes out to all affected stores, where employees then begin pulling products from shelves. Workers also identify products in backrooms, on trucks, and other locations throughout the supply chain.
Product containers are typically marked as recalled so they won’t be distributed to store shelves. In case that product is still out in circulation, retailers also block a recalled product’s UPC code so that it won’t scan at the register.
If some of those products have already been purchased, grocers must notify potentially affected shoppers. For Class 1 Recalls, retailers post signs at registers, on store bulletin boards, and at the point of purchase, telling consumers to bring in recalled products for a full refund. Retailers also post notices on their websites, and frequently use loyalty card data to identify and contact customers who purchased a recalled item.
You will find more infographics at Statista
Because recalls aren’t going away any time soon, based on recent statistical trends, the grocery retailer’s plan to deal with them is essential to instill confidence to your consumer base – no matter where the contamination occurred along the supply chain and who is responsible. Customers want the grocery store, the only part of the chain they interact with, to demonstrate that the entire food industry acted responsibly to get the problem resolved as quickly as possible.
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