When foreign matter gets into food, the consequences can be significant, particularly if that food makes its way to a consumer’s plate without detection. What liability does the food manufacturer have in an occurrence? According to Attorney E. Scott Austin, a member of Gentry Locke’s Criminal & Government Investigations practice group, liability and its repercussions will vary based not only on the steps taken in prevention, but on the type of matter in the food.
Regardless of the type, however, if foreign matter is detected in food and a consumer, customer, or the Department of Justice (DOJ) itself, wishes to bring legal charges against the manufacturer or other businesses in the food chain, a civil or criminal suit can be filed. (Note: Because regulations vary by state, Austin’s comments are based on those of Virginia, but are not to be considered legal advice for a particular situation.)
There are three types of foreign matter that can be found in food:
- Naturally Occurring Foreign Matter. This is something that is naturally occurring but should not be in the food, such as bone in hamburger. While it shouldn’t be in the final product, it is something a consumer could expect to occur, so, in Virginia, there’s no liability on the manufacturer if you are taking steps to prevent such occurrences.
- Non-Natural Foreign Objects. A foreign object is something that is not natural and should not be in the food, such as metal fragments in hamburger. It’s not supposed to be there; it’s irresponsible of the food producer for it to be there; and no consumer would expect it to be there. In such instances, Austin said, “You are strictly liable.”
- Pathogens. Although disease-causing pathogens, such as Salmonella, E. coli, and Listeriaare naturally occurring in the environment, no consumer would expect to get a foodborne illness from their food. “This is the tip of the spear for FDA and DOJ,” said Austin, who represented former Peanut Corporation of America (PCA) owner and CEO Stewart Parnell in the criminal case on the 2008-09 Salmonella outbreak linked to PCA.
LIABILITY. Thus, it is foreign objects and pathogens for which a manufacturer is most likely to be charged with liability.
Foreign objects have been a leading cause of food recalls in recent years — and the problem is often discovered because of a customer complaint or injury. If you receive a complaint, the first thing to do, Austin said, is to identify the lot number and any customers to whom that run may have been shipped. If the lot is still running, stop production, clean, and find the cause.
The positive aspect of foreign objects is that there is generally a finite amount of impact; you may have only one complaint, so it’s fairly easy to control. But if the foreign object causes injury, the cost can still be high as it does come with liability.
Pathogen-contaminated food that makes it to market, however, can have significantly greater costs and consequences for both the business and individuals, particularly if there is an outbreak or if a death results.
Thus, the first thing that should be done if pathogenic contamination is detected by anyone or any means, is to immediately notify all your customers to stop selling product, and recall all affected lots. Although this can increase liability in the short-term because you are telling your customers of the contamination potential, Austin said, “You’re way better off, because a lot of this is avoiding something worse. That ‘something worse’ is doing nothing or not enough.” And that, he said, could lead to a criminal conviction.
Although criminal cases are rare, they become more prevalent when there is an outbreak. Ever since the publication of The Yates memo in 2015 (above), there has been a trend toward making it a criminal matter, Austin said. In fact, the memo’s statement, “Both criminal and civil corporate investigations should focus on individuals from the inception of the investigation,” makes it clear that employees would be prosecuted, not just companies.
“That type of environment could be considered consumer protection or overzealousness,” Austin said. But either way, anyone who is high up in a company linked to an outbreak should immediately consider the possibility of it becoming a civil or criminal issue. “If you’re talking biological agents, contact FDA immediately,” he said. Stop producing product, clean, and get FDA in to see that you’ve done this. “It’s not enough to say you did it, you have to have documentation,” he said.
Additionally, the cleaning and inspection needs to be done by someone more than the quality assurance team who was in place at the time of the contamination. If you go to court, it’d be hard to say you had great people in charge of the clean-up, when it is the same people who were in charge when it happened, he said.
TESTING. One critical caution Austin noted from the PCA experience is that if you are testing for a pathogen, “you have to abide by the test results. It’s not okay to retest,” he said. For example, you don’t have to test for Salmonella, but if you do and the result is positive, you cannot retest to a negative.
Although there are false positives, a second negative test does not mean that there is no Salmonella because it is usually not homogeneous; it clusters, he said. In fact, this makes it unlikely that you will get a second positive.
In the PCA case, for example, only 12 (0.33%) of more than 3,500 samples tested in 2007-2008 came back positive for Salmonella.
“You cannot retest,” Austin reiterated. “Trust me, we learned that lesson the hard way.” PCA was, in fact, the first such criminal case tried, Austin said. “This is a new and burgeoning area of criminal law that the government is getting its hands around.”
Citing the 1982 intentional poisoning of Tylenol capsules, Austin said, “Tylenol set the standard when they pulled every Tylenol product off the market. That was the right thing to do. It is the safest thing to do from a company standpoint and an individual liability standpoint.”
PREVENTION. To keep from being held liable in a food contamination case — whether it be a foreign object or pathogen — you want to put in place quality assurance mechanisms that prevent it, Austin said.
Not only did he recommend that you have GMPs that cover pathogens, metal fragments, etc., Austin said you need to have FDA check them. The agency is required to check GMPs, but they don’t always read them, he said. “I encourage people to have FDA read and understand these.”
In the PCA case, Austin said, the company noted that their GMPs said they would retest positives, but FDA responded that they didn’t really read the GMPs.
Thus, Austin recommends three key steps for prevention:
- Have FDA read your GMPs.
- Get them approved.
- Follow them.
If you remember nothing else,” Austin said, “Make sure you have your GMPs thoroughly vetted and complete. And if there‘s a problem, you’ve followed them to the letter.” You want to have them in order before FDA knocks at your door.
The author is Editor of QA magazine. She can be reached at firstname.lastname@example.org.