How To Handle A Recall

The editors of American/Western Fruit Grower asked David Gombas, senior vice president, food safety and technology for United Fresh Produce Association, to share some tips on how growers can survive and overcome involvement in a product recall. Here are his thoughts:

Q: If a grower is involved in a recall, what is the first thing he/she should do?

A: In the event of a recall, the first thing growers should do is implement their recall plan. Of course, that means they need to have one to implement, which means that waiting for a recall to become prepared is far too late. Trying to handle a recall without a plan is like deciding to run a marathon without any training. Companies can survive a recall if they are unprepared, but it will always be more painful, emotional, and costly than if a company is prepared. And, without preparation, a company is far more likely to make a costly or even fatal mistake while handling the recall.

  • for a list of steps to take in developing and executing a recall plan.

Types Of Recalls

According to FDA’s website, recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.

- Class I recall: 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 recall: 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 recall: A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

- Market withdrawal: Occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

Q: Should the recall be handled differently depending on if it’s Class I, II, or III?

A: The first question should be, “Is this a recall, a product withdrawal, or a stock recovery?” FDA provides some guidance on this on their Web page. If the product is still completely in a company’s control, it’s a “stock recovery” and no recall is needed. A “product withdrawal” occurs when a product has a minor violation that would not be subject to FDA legal action. If a product has already changed hands and left the company’s control, but there’s no evidence (at most, only a suspicion) that the product is actually adulterated, then the product may be “withdrawn.” If there is evidence of adulteration (even if the evidence is found after a product is withdrawn), and the product may be in consumers’ hands, then it’s a recall. If the affected product hasn’t reached consumers yet, getting control of it and stopping it from going any farther can make all the difference in what happens next.

Recall classifications are decided by FDA, and often after the recall has been initiated. By the time a recall team calls the FDA Regional Recall Coordinator, they should have all of their facts in line, know where all of the affected product is and how to get it back, and, if it’s a food safety issue, have a press release ready to go. And all of this should happen within the first 24 hours. The recall team should want FDA to have confidence that the company knows what it’s doing and is doing it well.

After the FDA Regional Recall Coordinator is contacted, a company should expect that FDA or state agency investigators will be visiting soon. The government’s job is to make sure that the company is handling product safety as completely and as competently as it should. The company’s job is to demonstrate to the government investigators that it is. A company should be able to convince the investigators that it has taken the issue seriously, has investigated it aggressively, and is implementing effective corrective actions to reduce the risk of the issue happening again.

Q: What resources are out there to help growers if they are involved in a recall?

A: FDA provides recall guidance to the industry, including model press release letters, at www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm.

United Fresh offers a service to member companies during a crisis. We will work with a member’s recall team to review the evidence of the contamination, to review and provide advice on their recall plan, even work with them on communications. We don’t replace their recall team or write their recall plan, but we do provide a “sounding board” to help a company avoid the most common mistakes.

Q: Is there anything you’d like to add?

A: A company doesn’t have to do anything wrong to be caught in a recall situation. I’ve worked with many companies in these situations, and every one has been shocked to hear that a product they’ve handled might be contaminated. Many companies don’t survive a recall even if they are prepared; but fortune favors the prepared.

Last September, FDA created a new Reportable Food Registry. Any company that has evidence that an ingredient or product they’ve handled is adulterated, i.e., “a food or feed that may cause severe health consequences or death to humans or animals,” is legally obligated to report it to FDA through the RFR portal. Currently, farms are exempt and only companies that are required to have registered with FDA are required to comply, but growers should become familiar with the RFR nevertheless (www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/default.htm). Experience has shown that, if a packinghouse or subsequent customer reports a produce item in the RFR, the grower will almost always be included in the investigation.

There’s a mistaken perception that if a product has passed its use by or shelflife date, then no recall is necessary. Not so. If FDA thinks there is any reasonable chance that a contaminated product is still in consumers’ hands, even in a consumer’s freezer, they will very likely request a recall.

Knowing when to pull the trigger on a recall is one of the most difficult decisions a recall team will have to make. Too late, and you may have put more consumers at risk. Too soon, and the recall may not have been necessary and you’ve created unnecessary liability and costs, in dollars and to your company’s reputation.

For a list of steps to take in developing and executing a recall plan,

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