Voluntary Recalls are not Optional

Columns - Produce Production

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October 12, 2020

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There seems to be confusion in some parts of the industry on what is meant when there is a “voluntary recall.” The word “voluntary” is in contrast with “mandatory”; but when it comes to food safety recalls, particularly Class 1 recalls, “voluntary” does not mean optional, and it does not mean unnecessary. It does not imply that the recalling firm had a choice. And if you’re the customer of product that is subject to a “voluntary recall,” you don’t have a choice either. A recall is a recall, and appropriate action must be taken.

The Code of Federal Regulations (21 CFR 7) states, “Recall  means a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.  Recall  does not include a market withdrawal or a stock recovery.” This means that regardless of whether a recall is “voluntary” or “mandatory,” the food violates the law; it is illegal. Therefore, the recall, although initiated by the firm, is by no means discretionary.

Why has the term “voluntary recall” been used extensively? It may imply that the recalling firm is “doing the right thing” and protecting public health by choosing to recall a product. However, if that product has been linked to illness, tests positive for a pathogen, contains an undeclared allergen, or is otherwise violative, it would be completely irresponsible for a firm to not recall. Doing the “right thing” should be the default; it should not be voluntary.

Prior to the passage of FSMA, all produce-related recalls were voluntary, since FDA lacked mandatory recall authority. In some ways, labeling a recall “voluntary” was even more misleading in the pre-FSMA era, since there wasn’t an alternative.

Now, FDA does have mandatory recall authority — but this is seldom used and is a last resort. Additionally, this authority only applies to “registered facilities” not farms. Facilities need to be given the opportunity to recall on their own (e.g., “voluntarily”). It is only if a firm refuses to recall that FDA can initiate a process to mandate a recall. The industry does not want “mandatory recalls” to become commonplace.

Within the supply chain, the term “voluntary recall” causes a communication challenge when the receiving firm equates “voluntary” with “optional” and is not sure if it needs to carry the recall forward to its customers. Despite the short shelf life of many produce items, the supply chains can be complicated, with produce going from farm to packing operation to repacker to processor to manufacturer. At each point, product may be mixed and mingled with other lots and other products. Secondary, tertiary, and further recalls often mean that the total amount of product at the end of the supply chain may be massive relative to the amount of product subject to the initial recall. This scenario makes for a natural reluctance to recall product if it’s not absolutely necessary — and the term “voluntary” suggests that indeed, it’s not necessary to follow the recall through.

Another point to consider in the language used to convey recalls is the message it sends to consumers when a “voluntary recall” is announced. Does this mean it’s voluntary for them? Can they still eat the product, since they may perceive that producer did not actually have to recall, but instead, did it voluntarily? When a food is recalled due to a food safety issue, it’s critical that the industry provide consumers with clear directions to protect their health. Calling a recall “voluntary” does consumers a disservice that could result in illness, injury, or death.

I suggest that we abandon the term “voluntary recall” because it’s misleading and inaccurate. Instead, using the term “firm-initiated recall” would more accurately describe the situation and limit the confusion around the expectations for others in the supply chain, as well as consumers.

A recall is a recall, and if a recalling firm wants to “do the right thing,” it will communicate clearly, leaving no question as to the action that must be taken to remove the product from distribution.

Jennifer McEntire Vice President of Food Safety,  United Fresh Produce Association