The Preventive Controls for Human Food Rule, mandated by the Food Safety Modernization Act, requires written recall plans for any foods with a hazard requiring a preventive control, according to Ryan Gooley, product recall advisor with Sedgwick’s brand protection solutions. His expertise includes managing food recalls.
“Inevitably, something could happen with your product,” he says. “Everything is consumable so minimally, you always run the risk of having a foreign material object enter your product.”
A thorough plan can help companies avoid errors, mitigate risks, and even prevent deaths. If a food safety situation arises, the following steps should be taken:
1. Conduct an Investigation
If a company receives a complaint about its product, whether from a regulatory body or consumer, or if something it has produced tests positive for an undeclared allergen or pathogen, the food maker must investigate to determine when the problem first occurred and its scope. “The investigation may or may not warrant a recall,” says Gooley. “It depends on the risk or hazard to the individuals who may consume the product.”
2. Recall Preparation
If the issue is deemed what the USDA or FDA would consider a recallable event and the affected product has left the company’s control, the maker should move into recall preparation mode, says Gooley. This involves reviewing distribution history, tracing product to see where it went, determining what you will advise customers to do with the affected product, developing a communications plan including a press release, and a strategy for initiating a recall.
3. Initiate Recall
This step involves sending out communications to the appropriate agencies and customers so that affected product can be pulled back from the marketplace. As part of the reclamation process, the recalling firm may need to assist with the disposal of products and figure out what to do with tainted product that is left in-house. “This is a pretty heavy lift for most companies,” says Gooley. “They need to consider the resources they have available to them, both internally and externally, and how to manage implementation. They may need legal counsel, a public relations firm, or people to staff a call center for consumer inquiries, for instance.”
4. Recall Effectiveness Checks
During this stage, companies must ensure they are providing regular updates to the recall coordinator at the FDA or state agencies. They must also continue the appropriate outreach and document who they have heard back from to ensure that product is getting removed from the market and all necessary customers have been notified. “This is a process that most don’t follow diligently, and it’s driven by documentation and record keeping. It requires additional follow-ups and a full line of sight to what’s going on,” says Gooley. While the FDA is not typically looking for 100 percent product reconciliation, since a lot of impacted product has likely been consumed, thrown out, or lost, according to Gooley, it wants to ensure that the food maker has done its due diligence by documenting the actions taken and is taking the situation seriously. “They expect to see that the customer has acknowledged receipt of the recall notice, and if they have any product, how much, when was it destroyed or shipped out, and did they notify further down the supply chain as appropriate? This is information that the recalling firm is expected to gather from its primary customers,” Gooley says.
5. Termination of the Recall
This stage happens when effectiveness checks have been conducted and a company gets back all of the product that will likely be returned, says Gooley. In order to close out the recall with the agency, a company would need to submit a request for termination and present documents and records that show that proactive steps have been taken, including communications and responses from customers as well as inquiries from consumers. While not a matter that involves the regulatory agencies, the recalling firm will also need to ensure that charge back credits have been granted to retailers for affected products and recall management and handling fees have been paid to those who worked on removing product at the retail or distribution level. “You have to make sure that any necessary credits and product reconciliation have been resolved with your retail customers in an effort to allow you to get back to business and move past the recall,” says Gooley.
Related: FDA’s Food Traceability Rule and Its Effect on Specialty Food; General Mills CEO: Food Safety is Taken Very Seriously.