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Food SafetyCold Chain Perspectives

How user error results in food recalls

By Andrew Lorenz
We R Food Safety Andrew Lorenz
March 11, 2016

As everyone knows, the food industry is highly regulated and constantly under the magnifying glass. The question is though, how come there are so many recalls, even with all of this scrutiny? How can so much dangerous food be produced and shipped into commerce?

Sometimes “systems” fail because human beings are running the systems.

When you compare October 2013 to September 2015, there was a 15% increase in total food recalls, according to USDA FSIS and FDA websites. However, when broken down, there was actually a drop in recalls by the FDA. It was the USDA-regulated products that experienced 107% increase in recalls. And, recalls for direct food safety issues such as salmonella, E. coli or Listeria contamination remained the same or decreased.

But, the increase in recalls by the USDA FSIS can be attributed to two factors—misbranding and producing without the benefit of inspection.

When the term misbranding is used, it typically means that the product boasts an incorrect or illegal label. It might be for having an undeclared ingredient such as soy, or maybe it delivers an untrue nutritional or production claim, such as cage free when actually the birds were raised in cages. The gist is that the label is wrong.

There are a lot of different recalls for a variety of misbranding issues, including using the wrong size lettering, the wrong inspection legend, etc., however the vast majority concern the failure to declare allergens on the label. This typically happens when an ingredient formulation is changed and the processor fails to realize it. The producer’s system failed to detect the change in ingredients and failed to assure that the correct label was applied. This happens because USDA FSIS directed its inspectors to increase label reviews. Remember, over 50% of recalls are due to some form of misbranding.

The second major area of increased recalls is “producing product without the benefit of inspection.”  First off, this doesn’t apply to FDA-regulated products, only to USDA FSIS-regulated products, meat, poultry, eggs and catfish. In fact, there was a 500% increase in recalls due to producing product without the benefit of inspection. This typically means that the establishment produced product without paying overtime for government inspectors to be present, i.e. there was no inspection presence as required by the USDA FSIS.   

The key to rectifying this situation is understanding how the inspection process works. When a facility works under a grant of inspection, they receive eight hours of inspection per shift without being charged by the government. If it’s a processing-only facility, it’s typically on a patrol, which means that the inspector has multiple plants to visit each day. In some cases, the inspector is required to visit over eight plants in an 8-hour shift. In essence, that manufacturing facility is producing without an inspector present during the vast majority of the operating day, until going into overtime. That’s when the USDA FSIS does everything in its power to have inspection present.

So, why is it so important to have an inspector in the facility during overtime, but not that big of a deal when operating during the “free” eight hours? The USDA can and does charge the establishment for overtime. When I left the USDA in 2012, the number was over $130 million annually, and my guess is that it has gone up, not down.  When you think about the actual USDA FSIS budget of approximately a billion dollars a year, overtime is a substantial amount. 

To make sure that establishments don’t cheat, the government forces them to recall product if it is made “without the benefit of inspection.” 

Every year, USDA FSIS tries to charge a user fee for providing inspection, and every year they are turned down. Sometimes they forget that they are a regulatory body. Receiving payment can lead to conflicts of interest. 

Ultimately recalls for food should be because there is a risk to the public, but if federal regulators are so focused on collecting overtime fees, are they paying attention to what really matters?

KEYWORDS: food recalls FSIS regulations USDA-certified organic

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Andrew Lorenz is president of We R Food Safety, Menomonie, Wis.

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