The ubiquitous nature of Listeria has made it a difficult pathogen to detect, control, and find its root cause. Led by Gina Kramer, executive director of Savour Food Safety International, attendees of last week’s Listeria Detection & Control Workshop learned everything from the cost of Listeria ($1.4 million per case and $2.3–$22 billion in the United States annually) to the challenges of breaking down biofilms to the steps a company should be taking to do sanitation right and get rid of resident Listeria in their facility. Here’s a snapshot of what experts said as they addressed industry’s obligation to ensure that their facilities are constantly monitored for contamination to ensure that safe product comes out of their plants.
People equate local and organic with safer, safer, safer. That’s not true, because pathogens are agnostic. – Gina Kramer, executive director, Savour Food Safety International
Whole genome-based outbreak detection allows us to detect more quickly, with greater precision in identifying source — John Besser, Ph.D., Deputy Chief, Enteric Diseases Laboratory Branch, CDC
What’s happening in your plants? What are you taking into your processing plant? What time of year is it coming in? What is your environment—is it more urban or rural? The presence of Listeria isn’t any greater in an urban or rural environment. You might find it in different places, but there isn’t a difference in incidence. – Janet Buffer, corporate food safety manager, The Kroger Co.
Biofilm erupts like a volcano. But once it has erupted, your volcano goes dormant. And for how long? Nobody knows. That’s the problem. The biofilm can release two days later, a week, or a month later. – Dominique Blackman, general manager, Realzyme
Listeria testing is the ugly duckling in preventive controls. Companies need to ask themselves whether the method they use is able to detect potential positives in the environment. – Ted Andrews, senior director, product marketing, Roka Bioscience
Sanitation is not one size fits all. You need to have specific controls in place that look at controlling Listeria not just for equipment but periodic infrastructure and equipment and routines. Validate that they work. Train employees so they properly execute. – Jeff Mitchell, vice president of food safety, Chemstar
You’ve identified Listeria in your facility. Now what? Review touch points: This includes the air, surfaces, transportation and packaging areas. – Troy Smith, CEO, Radiant Industrial Solutions, LLC
If you get everything mostly right, what are the odds that you’ll find a pathogen in end product testing? Getting the proper data point is a big deal. – Douglas Marshall, Ph.D., chief scientific officer, Eurofins
In recent years, several food products typically considered safe by consumers have fallen victim to recalls as a result of Listeria monocytogenes (Lm). Caramel apples, ice cream, packaged salads and frozen vegetables were responsible for sickening dozens of people and killing more than 10. These products are part of an alarming group of common foods that have caused outbreaks, including milk, spinach, sprouts, peanut butter, cheese, cantaloupes and raw cookie dough. And the broad range of pathogens causing these outbreaks is just as diverse, and they continue to find creep into food processing facilities, finished food products and consumer homes.
At the 2016 Food Safety Consortium, Shawn Stevens will moderate the workshop session, Bringing the final FMSA pieces together: You have a basic preventative control program, what’s left? | Friday, December 9 | LEARN MORERegardless of sophistication or expertise in pathogen control, there isn’t a single company out there that is immune to the risk of contamination. Why? Well much of the foods (or ingredients) that we consume are grown and harvested in environments that are susceptible to contamination. Fruits, vegetables and other products, such as spices, can easily become contaminated with Lm, Salmonella or E. coli in the fields where they are grown, in transit or in the processing facilities.
Once pathogens are introduced into the processing environment, they can quickly spread and contaminate food products. Recent studies reveal that Listeria is a significant concern in these environments. For example, out of 5,000 samples from the food preparation areas of 30 retail grocery establishments, approximately 10% tested positive for Lm. These are scary numbers considering almost 16% of those who become infected with Lm will die.
In today’s new environment, FDA will be seeking justification to bring criminal charges whenever a contaminated product causes human illness. You should be nervous about this: If your company sells finished goods into commerce, those products may be selected for sampling and testing, and your company runs the risk that the results will come back positive for a pathogen of concern. And what’s more troubling is the fact that many companies do not conduct environmental testing in their food processing facilities, and so they have no idea whether pathogens (whether transient or resident) are lurking within their facilities. Thus, a microbiological profiling study conducted under the veil of the attorney-client privilege should be conducted to determine the presence of any microbiological persistence issues within a facility. Upon completion of the study, a company should invest in pathogen-reduction technologies to decrease the chances that FDA will uncover pathogens in the environment during an inspection. Finally perform a criminal protection audit to help strengthen company programs and develop protocols that will further protect against criminal exposure.
The bottom line is that if food companies do not take extraordinary measures to identify Lm in their facilities, perform a comprehensive investigation to find the root cause or source, and then destroy and eliminate it completely, the pathogen will likely persist and, over time, intermittently contaminate their finished products.
Microbiological Profiling Studies
Lesson number one from the Blue Bell Lm outbreak is that pathogens can be extremely elusive and, as a result, a simple environmental monitoring program will never save your company from being involved in an outbreak or being the focus of criminal sanctions. All food companies should be aggressively testing for Lm (or other pathogens, depending upon the product risk profile) in their facilities and must take strong action against sporadic or intermittent positive findings. Although many food companies view a single operational failure as the culprit of an outbreak, the reality is that in most cases, the cause is something far more subtle, far more persistent, and far more dangerous. In recent years, a large number of outbreaks have involved Lm and antibiotic-resistant Salmonella that was linked to products that had been processed over multiple months.
Food companies should conduct a comprehensive one-time microbiological profile for pathogens in their processing facilities. Be sure to coordinate your profiling study with a lawyer experienced in food safety to make sure that the study is designed correctly and that the results will be protected under the attorney-client privilege. Once the results are reported, the company can take care of any positive findings, identify the contamination source, implement technologies to reduce and control the contamination, and develop a microbiological control and monitoring program to ensure that the pathogen remains controlled moving forward.
Pathogen Reduction Technologies
The second lesson learned from the Blue Bell case is that, when Lm or any resistant pathogen is found sporadically in the environment, what was once regarded as effective corrective actions (i.e., re-cleaning, re-sanitizing and re-testing) are no longer enough. In addition to existing cleaning and sanitizing procedures, companies should use new pathogen reduction technologies to help control the environment.
Inexpensive air and surface treatment technology that sanitizes the food processing environment is now available. The treatment is approved for use in occupied spaces and provides 24-hour treatment of the environment. By using active air and surface treatment, food processing companies can gain a level of control and decrease the possibility that any pathogen, if introduced, will persist or establish a niche.
Puradigm, LLC, for instance, utilizes a multi- patented, NASA-based active air and surface sterilization approach to control pathogens in the food processing environment. In studies performed by Kansas State University, the company obtained a 2.9 Log reduction on environmental food contact surfaces in the food processing environment. Similar reductions for other pathogens are displayed in Table I.1
Microbial reductions on stainless steel associated with 24-hour treatment using Puradigm advanced oxidation cell
I make this observation because, given the risk created by the FDA’s war on pathogens, food companies should invest in technologies to better control pathogens in their food processing environments. Once these preventative technologies are put into place, companies can perform periodic microbiological monitoring to validate that the controls are effective and working as designed. If such solutions are employed, there is a greater likelihood that when FDA arrives to perform microbiological profiling, the agency will be less likely to find positive test results from the food processing environment, better protecting food companies from additional regulatory or criminal exposure.
Criminal Protection Audits
In addition to commissioning microbiological profiling studies in facilities and employing active air and surface sterilization technologies, food companies should also perform internal criminal protection audits. These audits should be designed to identify gaps in existing company protocols and develop written programs designed to help navigate the challenges posed by any food safety issues uncovered.
If developed correctly, the written program should provide the company with a decision-tree to follow in the event of a positive environmental finding, a series of customer complaints relating to the safety of a product, or a notification from a governmental entity of a potential food safety problem. These protocols and programs, if followed in the event of a food safety issue, can help ensure that the conduct of the company in response to any such issues will in all cases be appropriate, and that there will not be any basis upon which FDA or DOJ could support criminal charges.
Conclusion
The FDA (in cooperation with DOJ) has launched a war on pathogens. The agency is targeting food products at retail and engaging in microbiological profiling of all food companies. Unless companies act now to better quantify and control pathogens in the food processing environment, they are exposing themselves to incredible food safety risk, including significant brand damage (in the event of a recall) and criminal sanctions (if their product is linked to human illness). Companies must carefully consider the emerging risks facing them and take measures to decrease and eliminate their exposure.
Reference
GC/MS Evaluation of Compounds in Air Samples in a Controlled Environmental Chamber Equipped with a Puradigm Advanced Technology Cell, November 5, 2013, Dr. James Marsden, Kansas State University Food Science Institute.
There was been a significant uptick in the amount of foodborne illness outbreaks and food product recalls (there were more than 500 food product recalls last year), many of which have been caused by dangerous pathogens. As FSMA plays a role in addressing this alarming trend, FDA is making several policy changes that will only continue to intensify. The agency is conducting microbiological profiling both inside food processing facilities during routine inspections and testing large amounts of food at the retail level. In addition, it has launched criminal investigations against food companies distributing products that have the potential to cause human illness. In many of these cases, company executives did not have direct knowledge that their products were causing, or had the potential to cause, illness. Many investigations involve Listeria monocytogenes (LM) found in food processing environments or in food products in commerce. Under FDA’s new approach, the failure to eliminate sporadic LM findings in the environment can subject companies to criminal liability. The immediate challenge to the food industry is to find a more effective solution to identify and reduce pervasive pathogens in the processing environment using pathogen-reduction technologies, while simultaneously employing written food safety protocols that can provide additional protection against criminal sanctions.
PulseNet Makes Foodborne Illness Link
Following the conclusion of the infamous the Jack-In-The Box outbreak that sickened 600 and killed four people more than two decades ago, the federal government recognized that similar outbreaks were probably occurring throughout the country, but there were no viable means of detection. As a result, the CDC created the PulseNet database, a mandatory foodborne illness reporting system to detect and track outbreaks in real time. From there, when a patient tested positive for a pathogen of concern (such as Listeria Monocytogenes, Salmonella or E. coli O157:H7), his or her doctor had to report that finding to the state health department. Each state requests copies of the isolates and tests them for the specific genetic DNA fingerprint of the pathogen of interest. These fingerprints are uploaded to PulseNet, and when indistinguishable genetic DNA fingerprints are uploaded from multiple victims, the CDC can recognize that an outbreak is emerging. The agency shares this information with FDA and other federal, state and local health departments as they work to determine a common source. Despite the fact that most illnesses uploaded to PulseNet remain unsolved, the database has helped CDC and FDA solve hundreds of outbreaks that have affected thousands of victims.
My subsequent columns will look at the emerging challenges faced by the food industry, including recent federal criminal investigations, some solutions designed to assess environmental contamination and reduce pathogens, and strategies that you can employ to reduce criminal liability.
Dole’s bagged salad was the culprit of three more Listeria cases last month. Last week the FDA released the latest figures on the outbreak, which began in July 2015. An investigation was not initiated until September, and the source of Listeria—a Dole processing facility in Springfield, Ohio—was not known until January 2016. The CDC reports that 15 people, all which were hospitalized, in eight states have been infected with Listeria traced back to the Dole facility since July.
On January 21 Dole told the FDA and CDC that it both stopped producing all packaged salads at the Springfield facility and stated that it would be withdrawing all packaged salads on the market that were produced there. The company initiated the recall of the salads, which were sold under the brand names Dole, Fresh Selections, Simple Truth, Marketside, The Little Salad Bar, and President’s Choice Organics, last week. The bagged salads were distributed in 24 states.
The Public Health Agency of Canada also issued a food recall warning for products made at the Springfield facility. The products were shipped to six Canadian provinces.
As of late, the problems for Chipotle have been endless. 2015 was a year of several Salmonella, norovirus and E. coli outbreaks for the restaurant chain. With the first full week of the new year wrapped up, 2016 is off to perhaps an even rockier start, with news of the company being hit with both a class action lawsuit and a federal grand jury subpoena.
Company stockholder Susie Ong filed a civil complaint against Chipotle on January 8, stating that the company made false or misleading statements and failed to disclose that its “quality controls were inadequate to safeguard consumer and employee health.” Filed in the U.S. District Court for the Southern District of New York, the complaint calls out a norovirus outbreak that occurred in August in Simi Valley, California; a Salmonella outbreak in Minnesota that sickened 64 people; the closure of all company restaurants in Portland, Oregon and Seattle, Washington in November following an E.coli outbreak; and the highly-publicized norovirus outbreak that sickened more than 140 students from Boston College in Brighton, Massachusetts last month.
Ong’s complaint also mentions the federal grand jury subpoena, which Chipotle made public two days prior (January 6) in an SEC filing. Served in December, the subpoena is part of a criminal investigation by FDA and the U.S. Attorney’s Office for the Central District of California into the Simi Valley norovirus outbreak, which sickened about 100 patrons and employees (some reports state that more than 200 people fell ill). Ong’s lawsuit states that health inspectors found “dirty and inoperative equipment, equipment directly linked to the sewer, and other sanitary and health violations” at the Simi Valley restaurant.
With December’s norovirus outbreak in Brighton and the CDC’s announcement that it was further investigating five new cases of E. coli that were reported the month prior, restaurant sales were down 30% for the month, according to the SEC filing. Ong adds up all of these unfortunate events in the lawsuit, stating, “As a result of defendants’ wrongful acts and omissions, and the precipitous decline in the market value of the Company’s securities, Plaintiff and other Class members have suffered significant losses and damages.”
Chipotle has not yet publicly commented on the lawsuit.
Earlier in December, Chipotle called attention to improvements it was making to its food safety program by bringing in IEH Laboratories and Consulting Group to reevaluate its processes in an effort to prevent future outbreaks. Clearly that was not enough.
Food companies take heed. 2016 is off with a bang, and not in a good way. Last week industry was also buzzing about the DOJ’s investigation into Blue Bell Creameries over the deadly Listeria outbreak. FDA and the other federal powers-that-be are making it very clear that negligence will no longer be tolerated (Or should I say, alleged negligence, in this case). Compliance, accountability, and above all, ethical behavior are at the heart of the matter.
Will it all come tumbling down for Chipotle? It remains to be seen whether the company will be able to recover from these issues. And maybe an even bigger question is, who will be next?
Several news outlets have reported that the U.S. Department of Justice (DOJ) is investigating Blue Bell Creameries following the Listeria outbreak that resulted in three deaths in Kansas and 10 illnesses in Arizona, Kansas, Oklahoma and Texas between January 2010 and January 2015.
According to The Wall Street Journal, the DOJ is mainly interested in the involvement of company executives—did they know about the Listeria contamination? If so, what did they do about it?
Last April Blue Bell recalled all of its products over concerns of Listeria contamination and shut down the production line where the products were manufactured.
Blue Bell started a limited-release of its ice cream products last August. The company has not yet issued a response to the reports about the DOJ investigation, but last week it announced that it would begin a “bonus phase” of product re-entry in El Paso, Texas, Little Rock, Arkansas, and Memphis, Tennessee. This is scheduled to be followed by phase five of market re-entry in parts of Tennessee, Alabama, Georgia, Kentucky, North Carolina, South Carolina, and Virginia the week of January 18, and then shipment into all of Florida, southern Georgia and southern South Carolina the week of January 25.
The company stated in a press release that after phase five is completed, all of Blue Bell’s furloughed employees will have returned to work.
After bringing in IEH Laboratories and Consulting Group to reevaluate its practices after an E.coli outbreak that sickened dozens, Chipotle Mexican Grill announced it is implementing a program to ensure it achieves “the highest level of safety possible”. According to a press release issued today, Chipotle is enhancing its food safety program and taking the following actions:
Conducting high-resolution DNA-based testing of all fresh produce prior to shipment to restaurants
Conducting end-of-shelf-life testing of ingredient samples to ensure quality specifications are maintained throughout ingredient shelf life
Engaging in continuous improvements throughout its supply chain leveraging test result data to measure its vendor and supplier performance
Improving internal employee training related to food safety and food handling
The CDC and FDA investigation of the E. coli outbreak is ongoing and the source of the outbreak is still unknown.
In what is being called a groundbreaking decision, a federal judge sentenced three executives from the Peanut Corporation of America (PCA) to a combined 53 years in jail for their role in the 2008-2009 Salmonella outbreak. Stewart Parnell, former CEO of the no-longer-operating PCA, has been sentenced to 28 years; his brother, Michael Parnell, was handed 20 years; and Mary Wilkerson, quality assurance manager of the plant, was given 5 years. Convicted last year on 71 counts, Stewart Parnell was facing up to 803 years in prison, but at the age of 61, 28 years is essentially a life sentence.
The culprit of the fatal 2008 Salmonella outbreak was tainted peanut butter paste manufactured by PCA. Nine Americans died, and more than 700 people across 47 states were sickened. The outbreak led to the recall of more than 2,100 products. It was one of the largest food recalls in U.S. history, and the case has garnered national attention.
During yesterday’s sentencing, victims and their families asked U.S. District Court Judge W. Louis Sands to deliver a life sentence to Stewart Parnell; his daughter, Grey Adams, addressed the room, “My dad’s heart is genuine…” and said that her father and their family are “profoundly sorry” for the deadly outbreak. As Parnell addressed the victims in the Georgia courtroom, he made mention of the problems at the plant but did not comment on the emails and company records that indicate he had knowingly shipped tainted product or tampered with any lab records.
Earlier this year STOP Foodborne Illness’ Darin Detwiler commented on the significance of the sentencing in a video interview with Food Safety Tech, stating, “His actions resulted in technically more deaths than that of Charles Manson.”
Moving forward, the bar for accountability at the executive level has been set much higher. Victims, their families, and food safety advocates are applauding the sentencing. What do you think about the decision and its impact on the industry?
After receiving input from federal, state, and local regulatory officials, along with industry and trade associations, academia, and consumers, FDA issued its Voluntary National Retail Food Regulatory Program Standards last week. The standards address “what constitutes a highly effective and responsive retail food regulatory program,” according to the document.
The Retail Program Standards include:
Promoting the adoption of science-based guidelines from the FDA Food Code
Promoting improvement of training programs to ensure local, state, tribal, and territorial staff have the necessary skills, knowledge and abilities
Implementing risk-based inspection programs
Developing outbreak and food defense surveillance plans to enable systematic detection and response to foodborne illness or food contamination
The 2015 edition contains new worksheets that are intended to assist regulatory programs in looking at how their programs line up with the 2013 Food Code. This includes helping them assess the consistency and effectiveness of their enforcement activities, and a verification tool to help independent auditors with these self-assessments. Although jurisdictions can use the worksheets and other materials without enrolling in the Retail Program Standards, FDA encourages them to do so, as enrollment allows them to apply for FDA funding. The agency also lists the jurisdictions enrolled in the program here.
UPDATE: September 9: According to the CDC, 341 people have been reportedly infected with Salmonella from 30 states. Since September 3, the number of cases has increased by 56. Two deaths have now been reported (California and Texas). Andrew & Williamson Fresh Produce has voluntarily recalled all cucumbers sold under the “Limited Edition” label (between August 1 through September 3, 2015).
More information has been posted on the CDC website.
Across 27 states, an outbreak of Salmonella Poona linked to cucumbers grown in Mexico has led to one death and 53 reported hospitalizations, according to FDA. The agency released an update on Friday with the latest figures and information related to the outbreak and the product.
The product:
Cucumbers supplied by Andrew and William Fresh Produce of San Diego
Cucumbers grown in Baja, Mexico
Referred to as a “slicer” or “American” cucumber
Shipped in black, green, yellow cartons that read “Limited Edition Pole Grown Cucumbers”
The Salmonella outbreak (as of 9/3):
Where: Alaska (8), Arizona (60), Arkansas (6), California (51), Colorado (14), Idaho (8), Illinois (5), Kansas (1), Louisiana (3), Minnesota (12), Missouri (7), Montana (11), Nebraska (2), Nevada (7), New Mexico (15), New York (4), North Dakota (1), Ohio (2), Oklahoma (5), Oregon (3), South Carolina (6), Texas (9), Utah (30), Virginia (1), Washington (9), Wisconsin (2), and Wyoming (3)
Date range: July 3 to August 26, 2015
1 death
53 reported hospitalizations
Additional details are available on FDA’s website, and the agency will provide an update when new information is available.
As with any potential health hazard related to consumption of a food product, FDA is advising consumers not to eat the cucumbers. They are also urging restaurants to ask their suppliers what company supplied their cucumbers.
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