FDA Guidance on Recalls of Food Products due to Salmonella
03-12-2010
A recent list of recalls includes a product unfamiliar to most consumers but essential to many food processors – hydrolyzed vegetable proteins (both Dry Powder and Paste HVP). The product was recalled recently because of Salmonella contamination identified both in a finished consumer product and in a manufacturing facility after testing by the manufacturer and the FDA. Once again, an ingredient used in many food products faces a recall, begging the question: do you know your suppliers and are you sure they have effective recall plans in place? That is just one step in your recall preparedness analysis.
Now that this widely used ingredient has been identified as the source of Salmonella contamination, we can expect a flood of recalls of products in which it is used. We have already seen this pattern in the Peanut Corporation of America recall of peanut and peanut products, as well as the Setton Pistachio recall of roasted pistachios which led to a large number of subsequent recalls by manufacturers and repackers.
In the current HVP situation, the recalled products are generally used in small quantities, often as a seasoning. When considering whether or not to recall these products, the potential risk to health is, of course, a significant factor. Salmonella is a bacterium that ordinarily is sensitive to heat and high acidity. This sensitivity is considered during food processing in order to control the presence of the organism. Salmonella may be destroyed and products considered safe when the manufacturing process meets a sufficient time and temperature standard. The water activity of the product is also an important consideration and critical in relation to the time and temperature. The question of the day becomes: What can I do to prove to the FDA that my product safe and not subject to recall?
The FDA believes that the way HVP is used by food manufacturers will mitigate the risk from Salmonella in finished products. But the Agency also knows that there are many finished products for which this is not the case.
The FDA has provided guidance to the industry, and food manufacturers should evaluate their processes to determine whether the foods in which the potentially contaminated HVP was used were manufactured using a validated kill step for Salmonella. These manufacturers should submit documentation of the processing information – such as recipe, cook time and temperature, and water activity – to the FDA district recall coordinator who will forward the information to the Center for Food Safety and Applied Nutrition (CFSAN) for review. You must be aware that FDA does not allow the dilution factor to determine whether or not a product is violative or needs to be recalled. The CFSAN Recall Staff and technical experts are prepared to review the documentation in a timely manner.
Without proof of a kill step in the manufacturing process, FDA will expect you to recall your products. Even when you do everything right, one tainted ingredient can result in a major recall event. When dealing with products from other manufacturers, be sure they have a recall plan so that you are notified immediately if a recall is declared. But even more important, be sure your own recall preparedness is up to par so that when you have to recall a product, you can do it quickly and effectively.
Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.
4 Responses to “FDA Guidance on Recalls of Food Products due to Salmonella”
[...] Department of Health announced that an open container of black pepper used in the processing of the recalled products tested positive for Salmonella. In fact, the DNA fingerprint of the bacteria from the black pepper matched strain associated with [...]
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[...] have led to recalls which were at least in part attributable to the Registry, including the March HVP recall and a recall due to glass in animal [...]
[...] be credited to a multiplier effect. In both 2009 and 2010, the majority of recalls were a result of Salmonella concerns, including three recall events that subsequently led to multiple recalls of potentially [...]
