What is a recall?

FDA:

A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.

FSIS:

A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.

…well, “voluntary” in some cases is more how like most of us “voluntarily” show up to work every day…but in general, most recalls are initiated when companies become aware of an issue. And herein lies the problem with incentives. I present a fable of a small business.

Rita and Reginald, and the Risky Recall

Reginald enters the laboratory office, Rita is reviewing paperwork at a desk

Reginald: Oh dear, Rita, it appears the rubber ring from the giant spatula we use to make pie filling fell off during last weeks production!

Rita: Did you find it?

Reginald: No! It could have popped off while it was being washed, or it could be…inside one of the pies.

Rita: Oh no! We shipped them all! You’re telling me that somewhere in one of our pies is a nasty black piece of chewy rubber?

Reginald: I’m afraid it’s possible, it’s a ring about the size of a bottle cap. I mean, Theodore probably saw it and took it out while stirring, after all, our pie filling is bright red, it wouldn’t be hard to miss!

Rita: True, and it was clean….but someone could choke on that, and Theodore vowed to never speak of pie again after the incident!

Reginald: Well, those pies go bad in one week, most of them have probably already been eaten already?

Rita:…so what do we do?

What to do indeed! “Extraneous materials” are a common reason for recall. The safest food safety decision to make is to recall the affected pies. Rita and Reginald want to do the right thing, however if they issue a recall they are going to have an announcement like this one:

Rita and Reginald Pies, Inc., Recalls “Super scrumptious blog-style pies due to possible health risk.

Rita and Reginald Pies, Inc. announced today that out of an abundance of caution, it is voluntarily recalling retail, frozen pie products that may contain extraneous rubber materials, that despite our stringent supply standards may have been inadvertently introduced into the filling used to make this product. Consumption of these products may pose a choking hazard….Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase. There have been no reported injuries associated with the consumption of this product.

This recall will then be shared throughout the media, and in the comments section of Food Safety News:

Concerned Keyboard Writes:

How are there so many recalls these days! These big corporations are clearly trying to kill us all. I’m never buying pies again! #Rita&ReginaldREvil

Meanwhile, a happy pie eater happens to find a black piece of rubber as they slice a piece. They happen to work with equipment and go “hey, an o-ring” and either keep eating or stop. Maybe they call a relieved Rita and Reginald, maybe they don’t. Or maybe the gasket never made it into the filling, and was simply forgotten during assembly of the spatula.

Do you see the issue here? The Rita and Reginald in the story above decided that a recall was the most conservative action to keep their customers safe. However consumers punished them for it. A more business-oriented Reginald and Rita may have instead decided that it was unlikely that someone would choke on the gasket, if it was actually inside a pie, assuming they were right, or a situation as described above occurred, they took a less conservative assessment of the situation and were rewarded for it.

Really there’s a fundamental problem here. Somehow, in these situations where the actual risk is unclear (e.g. inconclusive microbial results), we’ve created an incentive for companies to be less conservative with their food safety/recall response.

So how can we change this structure? FDA and FSIS have a recall classification system that is intended to partially address this issue by identifying how dangerous an issue a recall is intended to address.

FDA:

• Class I – a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

• Class II – a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

• Class III – a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

FSIS:

• Class I – A Class I recall involves a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death.

• Class II – A Class II recall involves a potential health hazard situation in which there is a remote probability of adverse health consequences from eating the food.

• Class III – A Class III recall involves a situation in which eating the food will not cause adverse health consequences.

Here’s the thing. Consumers don’t read the classifications, or they aren’t carried over into press releases and news updates. Further, as long as a potential issue is a pathogen or injury, most become class I (example, failure to specify that your “peanut butter cookie” does not contain “peanuts” is a class I recall because it could cause anaphylaxis to someone with an allergy, regardless of the amount of obvious labeling in the product name), and even if consumers were paying attention to the categories, FDA has since adopted the policy of announcing recalls before a health risk assessment is made in order to speed up notification…but essentially removes the ability to report on the “seriousness” of the recall while it’s front page news. Updates are page 4.

I would argue that we should favor a system that instead focuses on the upper left corner of the table above, when an actual problem has been identified via illness, test result, or government enforcement action. I would see recalls re-categorized and renamed to something like this.

Fur, Farm, and Fork:

Public safety recall: Recalls conducted in response to consumer illness, injury, or government action/request.

Precautionary recall: Recalls conducted “out of an abundance of caution” where companies have initiated voluntary recalls due to questionable test results, GMP failures, or circumstances that may have resulted in an unsafe product.

The danger of recalled food does not come from companies that recall their products, but from the companies that don’t.

Those products are still out there, being bought and eaten at whatever level of risk the decision makers felt acceptable. We can’t change the financial impact of a recall, that incentive will always be there, but we can change the terminology we use to help the public understand when companies are actually dealing with a dangerous screw-up, or in the interest of food safety have taken the hit “out of an abundance of caution.”

After all, who’s more trustworthy? The person who tells you “I’ve never made a mistake” or the person who says “there was that one time, I apologized and made sure no one was hurt.”