A Weak Food Safety Program Could Land You in Jail!

Written by August Konie , MBA

Are you at risk of being held criminally liable, including jail time????

“DeLauro & Blumenthal?refer Board’s Head to DOJ for responsibility in Listeria outbreak, call on USDA to bolster oversight.”

By this headline, congressional and senatorial leaders are united in asking the Department of Justice to criminally hold Boar’s Head representatives liable for the company’s recent recall and calling for stricter enforcement of food safety regulations. Boar’s Head is responsible for a 7,000,000-lb recall of bratwurst and other ready-to-eat deli meats contaminated with Listeria monocytogenes causing 10 deaths and 59 hospitalizations to date. Regardless of civil action that Boar’s Head might face for damages, Congress is asking for direct criminal accountability.?

This is not unprecedented and appears to be the current position of the government and consumers when a major recall due to food safety occurs. Let’s examine some recent cases and the penalties they faced for failure in their food safety efforts.?

First, the Peanut Corporation of America (PCA) and their recall in 2008 and 2009 for Salmonella Typhimurium.?You may remember many peanut butter products suddenly disappearing from commerce around this time. By the end of the event, the outbreak was responsible for nine deaths and 700 cases of reported illness linked to the peanut butter products they sold. In 2014, PCA and three of its employees were found guilty in federal court on multiple counts of conspiracy, mail and wire fraud, sale of misbranded food, introduction of adulterated food into interstate commerce, and obstruction of justice.?

Here’s what the sentencing looked like:?

• President of PCA: 28 years in prison with three years of supervised release. He was 61 years old.?

• Head of Sales: 20 years in prison with three years of supervised release. He was 56 years old.?

• Quality Assurance Manager: Five years in prison with two years of supervised release. She was 41 years old.?

Another example is Quality Egg Company. In 2010, their shell eggs caused a nationwide outbreak of Salmonella Enteriditis, affecting over 290,000 eggs linked to more than 1,900 reported incidents of illness. Quality Egg and its employees were found guilty of producing and selling adulterated eggs as well as bribing a US Department of Agriculture (USDA) inspector.?

Here’s what the sentencing looked like:?

• Owner: Three months in prison.?

• Chief Operating Officer: Three months in prison.?

In addition to jail time, the company was also fined over $6.5 million in punitive damages. Settlements toward the 1,900 reported cases of illness were not disclosed.???

Under the current legislative landscape, it’s becoming increasingly evident that errors in a facility's food safety program are no longer just a money event but could now result in serious criminal consequences.?

So, how at risk are brands and manufacturers???

Pathogens in Food are Not As Uncommon As You Think?

It seems like bad business to not provide consumers with safe food products, yet, we continue to have hundreds of recalls per year as a direct result of food contamination with pathogens or poisonous substances.???

Between 2023 and the release of this article in 2024, the FDA and USDA have issued recalls, withdrawals, or safety notices for 233 different food or feed products. They range in size from a few lbs to some as large as the Boar’s Head recall in cases that involve food-borne pathogens such as Salmonella, Listeria, and E. coli. Others were caused by contamination from a bad ingredient source. That number almost doubles if you include food safety events involving undeclared food allergens.???

Included in the 233 total notices are 23 FDA recall notices directly related to animal food. In addition to the common food-borne pathogens previously discussed, animal feed is more prone to issues such as aflatoxin and mold contamination than human food products, and many of the animal feed recalls can be linked to the emergence of the fresh and freeze-dried pet food markets. Food safety is more critical in these markets because these foods undergo gentler processing methods than traditional kibble or canned food, which are subjected to high thermal treatments. Remember, the manufacturer is ultimately responsible for safe food production.?

If the federal government were to prosecute all of these recalls as federal crimes, it is possible that 233 brand leaders may face jail time. As a food safety professional, I am very concerned about this, as one day I might have to face such challenges. Will you???

Recalls are very expensive for a brand or manufacturer?

Recalls are expensive!?Many executives and brand leaders do not understand the severity of damage and hefty price tag they could suffer.?To put this in perspective, let’s look at a few notable recalls and the financial impact on their companies.?

Here are the top five most costly food recalls due to food safety concerns:?

1. Peanut Corporation of America (2009):? Estimated cost of around $1 billion due to a massive Salmonella outbreak causing nine deaths and 714 illnesses.?
2. Pilgrim’s Pride (2002): Listeria contamination led to a $300 million recall of ready-to-eat chicken products, resulting in seven deaths and 46 illnesses.?
3. ConAgra Foods (2007): A Salmonella outbreak linked to peanut butter resulted in a $288 million recall and hundreds of illnesses.?
4. Blue Bell Creameries (2015): Listeria contamination of ice cream products led to a $125 million recall.?
5. Menu Foods (2007): A pet food recall due to melamine contamination cost around $60 million and led to the deaths of many pets.?

You probably recognize many of the names on this list, but it’s important to note that private companies may not even report their recall costs. Often, smaller companies facing recalls costing only a?few million dollars would have to declare bankruptcy.???

But I have recall insurance??

Not all recall insurance is created equal in food safety events.?The costs of a recall are like ripples in a pond when you drop a stone in it.?There are so many costs that most companies never anticipate the full range of expenses they will face.?

Most companies rely on general liability insurance for recalls, which typically only covers the brand owner and their customers for the price of lost product in the event of a withdrawal. This isn’t enough! Don’t make the mistake of underinsuring your company. Even though it may cost you 10 times as much as general liability insurance, select a more comprehensive plan. If you have a recall, it will be worth every penny.? Additionally, consider consulting a food safety professional to better understand the full spectrum of costs associated with a recall.? It’s a much longer list than you might think.?

There are many other expenses not on this short list, but here are some of the larger expenses typically associated with recalls:?

1. Product Retrieval and Destruction: This includes retrieving, transporting, and properly disposing of recalled products. It often involves stopping production, pulling inventory from warehouses, and clearing shelves from retail partners. In the 2007 pet food recall, Menu Foods incurred millions in costs just for the logistics of retrieving its products across North America.?
2. Legal and Settlement Costs: Recalls often lead to litigation, with companies facing lawsuits from affected consumers or businesses. These can result in significant legal fees and settlements, particularly if the recall leads to injuries or deaths. The melamine-related pet food recall led to multiple lawsuits that were eventually settled for approximately $24 million.?
3. Regulatory Fines and Penalties: If a company is found to have violated food safety regulations, it may face fines from government agencies such as the FDA in the U.S. or other regulatory bodies depending on the country. In cases like the Peanut Corporation of America recall, criminal charges and penalties were levied against the company for violations of food safety laws.?
4. Brand Damage and Loss of Sales: Even after a recall, companies suffer a loss of reputation and consumer trust. This can result in long-term declines in sales, as consumers may switch to competitors. After the 2007 Menu Foods recall, many consumers shifted to other pet food brands, causing long-term damage to Menu Foods' brand that contributed to its eventual closure.?
5. Operational and Production Downtime: In many cases, companies must stop production to investigate the source of contamination and make necessary changes. This downtime can last days or even months, leading to significant lost revenue. In the case of the Quality Egg recall, operations were severely disrupted as the company was forced to halt production to comply with the recall and subsequent investigations.?

Each of these costs can result in significant financial losses for a company, sometimes running into tens or hundreds of millions of dollars depending on the scale of the recall.?

It is important that manufacturers have a thorough and detailed crisis management plan and consult with food safety experts experienced in recalls.? Experienced professionals can assist with media releases, regaining brand reputation, managing FDA and USDA correspondences, corrective action, building your best plan of action, and more.?

Why does this keep happening?? We have a great Food Safety Plan.???

My answer would be, do you?? Ask yourself the following questions:?

1. Do you have a qualified preventative control professional that has a background in food safety, or do you have a person that was promoted because at one time they did a quality job????
2. Do you have the right number of employees dedicated to food safety???
3. Does these employees report to operations or procurement??
4. How much of your annual budget is spent on direct food safety testing and food safety training????
5. Do you know what your worst non-food-safe day is???
6. Have you identified your areas of high risk within the facility???
7. Does your food safety team have the authority to scrap products when needed???
8. Do you perform the right number of tests on your product and at the right steps to know your product is safe??
9. Do you engage outside resources when you know that you do not have the subject matter expertise to make appropriate recommendations???
10. Do you have strict rules that suppliers must follow to be your supplier?? Are food safety controls part of those requirements?? Do you provide feedback to your suppliers regularly???
11. How much is your facility working against you?? Do you know what to look for???
12. Does someone on your team understand the pathology of the organisms you are trying to control???
13. Do you employ a multi-hurdle approach to food safety????
14. Are your employees following procedures that prevent cross-contamination??
15. Do you fully understand your rework process??
16. Do you have a strong and tested traceability program??
17. When did your last deep cleaning occur and was your microbial testing all negative????

If you don’t know the answers to these questions, as well as others related to this subject, you are probably putting yourself at risk of going to jail. Often, companies put money ahead of doing what’s right and, in this case, you truly are placing yourself at a high risk of landing in jail.? However, there is some good news here: in less than two years, there are 233 other manufacturers that may be joining you. They too thought they had a robust food safety program.?

From my experience as a food safety detective, troubleshooter, and a 25-year sleuth of food safety concerns, it is with the above questions and more where the food safety program falls apart. Generally, when a food safety concern, especially pathogens, escape the control of the plant, it is due to not just one failure of the system but many failures throughout the entire process. Commonly, the amount of product involved in a recall grows because either the facility cannot demonstrate they knew about the problem or cannot demonstrate when the last time they had a tested, clean lot of products.???

There is hope!?

All food manufacturing facilities have the potential (and duty) to produce safe food products.?Reimagining your food safety program and building your culture completely around food safety will maximize the effectiveness of your food safety program. Hopefully, this will allow your company to avoid recalls and market withdrawals so you never have to initiate your crisis management plan.???

Following these simple steps can go a long way towards building a robust food safety program:?

1. Foster a food safety culture. Make it a priority every day.?
2. Build a team of food safety professionals or retain them.?
3. Train all employees and visitors who may contact food on proper food safety measures.?
4. Complete a comprehensive risk assessment for food safety for the types of foods you produce.?
5. Find out what companies of perceived high quality and food safety are spending on food safety interventions and material testing. Work to match that spend.?
6. Food Safety and Quality teams should have their own reporting structure, in most cases.?
7. Build your food safety program around your worst day of production, not your normal day.?
8. Know what you don’t know. In other words, test your program with third-party eyes and conduct real assessments.???
9. Create a robust traceability and crisis management program. Test them several times a year.?
10. Continuously improve and critically reassess your programs.??

Don’t know where to start??

The topic of food safety has become a major focus within the United States.? Nowadays, incidents of food-borne illness are being reported and closely monitored in real-time. Genetic testing makes it easier than ever to link incidents to outbreaks. It is not acceptable, given the depth of current science, to avoid accountability.? It is no longer okay to say, “I didn’t know.”???

Help is available for even the smallest of companies with limited budgets.? Consulting firms like BSM Partners, through their food safety, quality, and regulatory practice, BSM Assurance, specialize in taking your food safety program from one that is merely meeting regulatory requirements to one that packs a punch.??

About the author: August Konie , MS, MBA, has been a food safety and quality professional with various teams for over 30 years.