Tag Archives: Focus Article

Gina Kramer
Food Safety Think Tank

Rapid, On-site Pathogen Testing a Game Changer

By Gina R. Nicholson-Kramer
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Gina Kramer

Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MOREWaiting days for test sample results can be the difference between keeping consumers safe and allowing contaminated food to enter the supply chain. I recently spoke with Mark Byrne, president and CEO of start-up ProteoSense, about his company’s portable pathogen detection system, which can find foodborne pathogens in food and environmental samples in 15 minutes or less, with no incubation required. Licensed from Ohio State University, the technology, called RapidScan, has unique sensor technology that provides a sensitive and specific assay with very low noise to enable a direct measurement of the presence of a pathogen.

When I asked Mark what effect he thought this technology would have on the food industry, he said: “I think the effect is going to be very profound. First of all, anytime you can give management information quickly, it changes their ability to respond, to take action.”

The technology has the potential to help companies deliver food to consumers safer and faster, and with less waste. Samples can be tested at various parts of the food supply chain, from in the field to final packaging.

RapidScan has been demonstrated for Salmonella, and ProteoSense is working on a Listeria assay. If all goes as planned, we can expect to see the product on the market in 2017. Watch my discussion with Mark to learn more about this innovative technology and how it could help you mitigate risks in your supply chain.

 

Guess What? Canada’s Food Safety System Comparable to United States

By Food Safety Tech Staff
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Yesterday the FDA, Canadian Food Inspection Agency (CFIA) and the Department of Health Canada signed an agreement that recognizes their food safety systems as comparable. Signed at an FDA-CFIA Health Canada Joint Committee on Food Safety meeting, the agreement will allow the agencies to leverage their regulatory systems and partner on various activities such as oversight when prioritizing inspections, scientific collaboration, and outbreak response.

“This arrangement is part of the US-Canada Regulatory Cooperation Council in which the countries intend to better align their food safety regulatory systems, reduce unnecessary duplication, enhance information sharing, and to the extent possible, leverage resources so that the agencies can better meet their public health objectives,” said Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA in a statement.

According to an FDA release: “Systems recognition involves reviewing a foreign country’s domestic food safety regulatory system to determine if it has legal authorities and regulatory tools that together provide public health outcomes comparable to those provided by the FDA. Domestic systems provide the baseline level of public health protection that helps assure the safety of exported foods from that country. Systems recognition will help the FDA be more risk-based in planning the scope and frequency of its inspection activities, including foreign facility inspections, import field exams, and import sampling.”

The agencies used the International Comparability Assessment Tool to conduct a systems recognition review and assessment involving elements of Canada’s national food safety control system. This included examining laws and regulations, inspection programs, response to outbreaks, and other compliance, enforcement and lab support activities.

Text of the agreement between the agencies is available on FDA’s website.

Recall

More Than 358 Frozen Foods Recalled Over Listeria Concerns

By Food Safety Tech Staff
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Recall

Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MORE–UPDATE–May 5, 2016–The CDC has reported that eight people have been infected with Listeria from three states from September 2013 to March 2016. According to an FDA release, whole genome sequencing conducted from a routine product sampling program by the Ohio Department of Agriculture revealed Listeria monocytogenes (Lm) from frozen corn and that it was closely related genetically to seven bacterial isolates from those sickened. It found a similar result from frozen peas, with an Lm isolate closely related genetically to one isolate from one person. “This close genetic relationship provides additional evidence that the people in this outbreak became ill from eating frozen vegetables produced by CRF Frozen Foods,” the release stated.

In March FDA collected environmental samples from Oregon Potato Company (also located in Pasco, WA), which were found to be closely related genetically to seven isolates of sickened people linked to the outbreak. As a result Oregon Potato voluntarily recalled its wholesale onion products. “FDA is working to identify other parts of the relevant supply chain that may have product relating to this outbreak. However, FDA is prohibited by law from releasing publicly certain information about supply chains, which may constitute confidential commercial information,” according to the release.

The agency is trying to determine whether there is a connection between product sample isolates and environmental samples taken. FDA called it a “complex and ongoing investigation”.

–END UPDATE–

Pasco, Washington-based CRF Frozen Foods has expanded a nationwide voluntary recall of its frozen fruits and vegetables over concerns that the products may be contaminated with Listeria. The recall, which also includes products sold in Canada,  encompasses more than 358 consumer products sold under 42 different brands of frozen organic and traditional fruit and vegetable products that were manufactured or processed in CRF’s facility since May 2014. Seven people from at least three states have been sickened and hospitalized due to Listeria. According to an announcement on FDA’s website,  “Some of these illnesses have been linked to consuming CRF-manufactured or processed products. CDC also informed us that, sadly, two of these individuals later died, but that Listeria was not the cause of death in either person.”

CRF suspended operations at its facility in Pasco, Washington on April 25 (following the first voluntary recall) and all affected retailers have been notified.

According to the FDA announcement:

“Products include organic and non-organic broccoli, butternut squash, carrots, cauliflower, corn, edamame, green beans, Italian beans, kale, leeks, lima beans, onions, peas, pepper strips, potatoes, potato medley, root medley, spinach, sweet potatoes, various vegetable medleys, blends, and stir fry packages, blueberries, cherries, cranberries, peaches, raspberries, and strawberries.”

The full list is available on FDA’s website.

Sanitary Transportation of Human and AnimalFood

Ready, Set, Train! Sanitary Transport Rule Is Here

By Holly Mockus
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Sanitary Transportation of Human and AnimalFood

The Sanitary Transportation of Human and Animal Food rule goes into effect June 6, 2016. Large businesses must comply by April 6, 2017; small businesses must comply by April 6, 2018. The rule governs the protection of food during transport, including the sanitation of transport vehicles and equipment, refrigeration of food for safety, and proper cleaning of bulk transport vehicles between loads. So you’ll need a game plan…but what should your game plan include?

  1. Read the rule—every word of it—to understand the reasoning behind the decisions made in crafting it and to get a glimpse into how it will be regulated and enforced.
  2. Review all of your processes, protocols, procedures, and contracts to ensure compliance with the rule, and outline responsibility for how you’ll manage the safe transportation of food.
  3. Close any gaps in your current programs to ensure you’ll meet the regulations well in advance of the compliance date.
  4. Kick the tires by conducting mock inspections. Find non-compliances and give yourself time to correct them, rather than wait for bad news during a real inspection.
  5. Confirm the accuracy of all your documentation on a regular basis. Documentation can be the difference between success and failure when it comes to proving that you’re doing the right things.
  6. Get all stakeholders on board to empower employees at all levels and drive culture change.
Sanitary Transportation of Human and AnimalFood
Establish a driver training program to ensure compliance with the Sanitary Transport rule. Image courtesy of Alchemy Systems (Click to enlarge)

Use Driver Training to Prepare

Drivers are the conductors of the food supply chain. They literally have loads of responsibilities, including maintaining the cold chain, meeting delivery requirements, practicing safe driving always, and meeting all Department of Transportation regulations and requirements. Whether transporting raw materials, packaging, work-in-progress, or finished goods, drivers are the people that keep food safe in transit. So how can you take advantage of your driver training program to ensure compliance with the Sanitary Transport rule?

  • A blended learning strategy, combining online and instructor-led training, has been shown to provide the best food safety training outcomes.
  • Use online lessons to introduce and reinforce knowledge of new FSMA regulations and food safety awareness topics. Digital lessons are economical, learner-paced, provide consistent messaging, and are accessible 24/7.
  • Use hands-on direct instruction for refreshers or for topics like proper vehicle inspections, reefer unit checks, cargo securement, etc.
  • Subject matter experts should conduct any instructor-led training using a skills check-off approach to document driver’s abilities and to ensure that drivers perform to standard.
  • Group and prioritize drivers for training based on their compliance history.
  • Use online lessons and safety messaging proactively to sustain driver compliance and performance.

Use online training at least quarterly, but use safety messaging monthly. Drivers, like all learners, need regular reminders in order to break old habits and form new ones. Communications programs can provide multi-touchpoints to reinforce new knowledge, shift behaviors, and help ensure compliance.

Put Your Game Plan Into Action

The Sanitary Transport Rule is a reality. Now is the time to put written procedures and protocols in place and make sure all stakeholders have a clear understanding of them. Determine precisely who has responsibility for compliance throughout the distribution channels. A blend of online and face-to-face training will ensure compliance, increase performance, and protect foods during transportation operations. The benefits far outweigh the cost.

Resources

DOJ Launches Criminal Investigation into Dole

By Food Safety Tech Staff
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Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MOREOn Friday the news broke that the U.S. Department of Justice (DOJ) was investigating Dole Food Co. over the Listeria outbreak involving packaged salad. The deadly outbreak was linked to salad produced at Dole’s Springfield, Ohio facility. Although the DOJ has not yet commented on the criminal investigation, The Wall Street Journal reports that Dole reported positive Listeria samples at its facility as early as July 2014.

In January 2016, Dole voluntarily recalled all salad mixes produced at the Springfield plant, by which point 33 people in the United States and Canada had fallen ill with Listeria and four had died. The CDC reported on March 31 that the outbreak appeared to be over and Dole restarted production at the Springfield facility in April.

In a press release on the company’s website, Dole stated that the issues FDA reported at its Springfield facility have been corrected. “We have been working in collaboration with the FDA and other authorities to implement ongoing improved testing, sanitation and procedure enhancements, which have resulted in the recent reopening of our Springfield salad plant.” It also acknowledged that it had been contacted by the DOJ related to an investigation and will be cooperating with the department.

Listeria

Listeria Workshop to Tackle Prevention, Detection and Mitigation

By Food Safety Tech Staff
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Listeria

More effective environmental monitoring and improved sanitation practices, along with databases such as PulseNet, are helping the industry find Listeria contamination. However, once detected, many processing facilities have difficulty removing the bacteria.

Next month Food Safety Tech is holding a Listeria Detection & Control Workshop to educate food industry professionals about how to integrate prevention and mitigation procedures into existing sanitation, operation and testing programs. The two-day workshop, which takes place May 31 – June 1 in St. Paul, MN, will cover the basics of controlling Listeria, along with the following topics:

  • Detecting and penetrating biofilm
  • How to build an effective environmental testing program
  • Producing reliable testing to detect and control Listeria
  • Sanitation departmental role in prevention, control and mitigation
  • Building a master sanitation schedule
  • Innovative Listeria mitigation programs
  • Gaps in proactive food safety programs
  • Hygienic equipment design

Industry speakers include:

  • John Besser, Ph.D., deputy chief, enteric disease laboratory branch, CDC
  • Gina (Nicholson) Kramer, Savour Food Safety International
  • Dominique Blackman, Realzyme
  • Janet Buffer, The Kroger Company
  • Ken Davenport, Ph.D., 3M Food Safety
  • Bert de Vegt, Micreos Food Safety
  • Joellen Feirtag, Ph.D., University of Minnesota
  • Melinda Hayman, Ph.D., GMA
  • Sanja Illic, Ph.D., Ohio State University
  • Paul Lorcheim, ClorDiSys Solutions
  • Douglas Marshal, Ph.D., Eurofins Scientific
  • Jeff Mitchell, Chemstar
  • Megan Murn, Microbiologics
  • Robin Peterson, Micreos
  • Errol Raghubeer, Ph.D., Avure Technologies

The event takes place at the 3M Innovation Center in St. Paul, Minnesota. Workshop hours are Tuesday, May 31 from 11:00 am–6:00 pm and Wednesday, June 1 from 8:30 am–5:00 pm. For more information, visit the Listeria Detection & Control Workshop event website.

EMAlert, Economically motivated adulteration

Food Fraud: Perps Two Steps Ahead, Innovation Needed to Keep Up

By Maria Fontanazza
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EMAlert, Economically motivated adulteration

Economically motivated adulteration (EMA) has considerable economic ramifications, impacting businesses from a financial and liability perspective, posing dangers to consumers, and eroding product confidence. One of the biggest issues with monitoring the volume and type of adulterated products is the fact that the landscape of food fraud is ever changing. “The perpetrators are always two steps ahead, so innovation is needed to keep up,” said Jeff Moore, Ph.D., director of science, food program at U.S. Pharmacopeial Convention (USP), at the GMA Science Forum last week.

GMA and Battelle have teamed up to launch EMAlert, a tool that companies can use to quantitatively assess the vulnerability of their supply chains to EMA. The secure, cloud-based platform comes with 50 commodities off the shelf (including spices, grains, dairy, seafood, meat, oils, fruits, veggies, and food ingredients). It was developed fairly rapidly (Battelle, which serves as the technology provider, started development at the beginning of this year) and still needs to be validated; full validation will be presented at the IAFP meeting this summer. And if EMAlert lives up to its potential, it could help companies be more nimble in monitoring and acting on threats in their supply chain.

The purpose of the tool is to generate quantitative vulnerability results that allow people to make actionable decisions based on numeric values. As such, it has been designed to be dynamic and customizable, since every company has its own risk tolerance. In addition, it looks at real-time environmental changes, because you can’t have a static tool to monitor vulnerability when it’s always changing, said Joseph A. Scimeca, Ph.D., vice president, global regulatory & scientific affairs at Cargill, Inc.

EMAlert, Economically motivated adulteration
A screenshot of EMAlert

“The EMA threat is changing,” said Ashley Kubatko, principal research scientist at the Battelle Memorial Institute. “A static assessment is only a snapshot in time.” EMAlert pulls live, automated data that takes into account economic drivers (value, volume, and scarcity of product), historical drivers (how often has product adulteration occurred in the past, geopolitical stability), and ease drivers (how frequently the commodity is tested; whether there are government regulations around the commodity group; how often the product changes hands or is repackaged). Data is pulled from several databases, including FDA, UN Comtrade, USP, Quandi, and Transparency International.

When creating the tool Battelle borrowed from its approach in working with the U.S. Department of Homeland Security to develop models that predict terrorist decision making and used the same mathematical methodology, providing a predictive model of fraudster behavior. Keeping in mind that perpetrators are also constantly monitoring how law enforcement and industry is keeping track of their strategies, EMAlert not only requires a subscription, but Kubatko says that Battelle will also be monitoring its users to ensure there is no suspicious activity within EMAlert.

Michelle Jones, Shake Shack
Retail Food Safety Forum

Simple Food Safety Training Combats Turnover

By Michelle Jones
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Michelle Jones, Shake Shack

Retail food establishments face many challenges, and employee retention is one of the major concerns. Employee retention affects scheduling, hiring, and the overall effectiveness of training.  Food safety training usually suffers when turnover occurs.

The safety of customers is dependent on an employee’s knowledge and execution of the food safety standards that are in place.

The biggest challenge in training in the retail/hospitality industry is the risk that the employee may leave within the first year (or less) of employment. According to Restaurant.org, the average turnover rate for the restaurant/hospitality sector was 66.3% in 2014.1 This turnover rate creates a challenge for maintaining a solid food safety culture.

Restaurants can take proactive steps to create and maintain a food safety culture that is always visible to new and current employees by adopting various techniques.

Signage Is Your Friend

Signage throughout your restaurant is a great way to continuously relay a food safety message without confining employees to a computer or module-based system.  This signage should be simple, sometimes playful and right to the point. An employee or manager takes roughly 30 seconds, on average, to read a message, so the shorter the better.

Visual signage is always a great tool to use in the back of house to relay food safety standards (e.g., proper cooking temperatures, order of storing food in coolers, etc.).  Signage (photos specifically) may also assist employees who may not communicate in English proficiently.  A picture is worth a thousand words, so utilize photos, cartoons or captions in order to relay the message.

Target the Leader

A quality assurance/food safety team should focus its training on the leaders of a region and/or district. Managers have more incentive to stay with companies longer; therefore, food safety training will be retained for a longer period. They may also visit their locations more frequently than the food safety professional, which gives them additional contact with the restaurant-level staff.

To assist these managers in their communication and verification of standards, compose a customized checklist for them to complete during a restaurant visit. The checklist should fulfill the following:

  1. Highlight the top opportunities they seek out (hand washing, sanitizer concentration, etc.)
  2. Provide the proper corrective action to eliminate the opportunities
  3. Considers their time.  A manager does not have the ability to complete a five-page checklist. Keep it simple—just the facts!

If these managers are well versed on food safety and sanitation and procedures, they will be able to hold their restaurants to a higher level of compliance.  So provide them with all of the tools they need to communicate to their employees.

Informed Employees Are Powerful Employees

Creating newsletters or publications serve as a great tool to keep employees informed of food safety policies. These articles can highlight trends in your company and new products available for use (i.e., chemicals, thermometers, etc.).

By law, every restaurant must have an area where employee information is listed (minimum wage, disability rights, etc.).  This board is the perfect place to post your publication.

In conclusion, keeping employees trained on proper food safety standards is the best way to ensure your customers are safe and your brand is protected. Implementing various forms of communication of these standards will create a strong foundation for an excellent food safety culture to exist.

Reference

  1. National Restaurant Association. Hospitality employee turnover rose in 2014.  March 11, 2015.
magnifying glass

How to Survive an FDA Foreign Facility Inspection

By Maria Fontanazza
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magnifying glass

Since 2002, the amount of FDA-regulated food imported to the United States has nearly doubled. With the implementation of FSMA well underway, expect that FDA will be increasing its inspections at foreign manufacturing facilities. When prioritizing inspections, FDA looks at a facility’s compliance history, the risk of the product manufactured in the plant, the date of its last inspection, and any import alerts associated with the site.

First and foremost, it’s important to make sure your foreign facility understands what a food safety plan under FSMA requires, said Chengboey Lau, principal scientist for North America scientific & regulatory affairs at Mondelēz International.  Today at the GMA Science Forum Lau pulled from the experience of Mondelez (the $30 billion-company has more than 165 manufacturing plants worldwide and requires all of its suppliers to be GFSI certified) to provide some helpful tips on how a company can get ready for an FDA inspection of a foreign facility, what it should do during the event, and the steps that should be taken afterwards.

Prepare for the Inspection

  • Develop an internal policy for foreign inspections
  • To ensure readiness at all times, implement a proactive program that involves the following activities
    • Annual review of registered facilities
    • Review of any products or materials made for U.S. markets (including R&D samples)
    • Gap assessments to ensure compliance with FDA requirements, followed by an action plan to close identified gaps
    • Employee training on FDA requirements
    • Create a site-specific FDA inspection manual for all necessary documentation

Survive the Inspection

  • Align expectations with the inspector at the start of the inspection
  • Have an employee who has strong English skills present to help with translation (the employee should have an understanding of American slang, too)
  • Consider having a U.S. regulatory support colleague available for questions during the inspection

Post-inspection

  • Email the inspector or make a Freedom of Information Act request if you don’t receive an establishment inspection report after six months
  • If a form 483 letter is issued, respond in writing within 15 days, and follow up within 40 days to inform FDA of the completion of any corrective actions

At the end of the day, make sure you have a firm understanding of which final FSMA rules apply to your organization, advised Lau. From there companies should perform a gap analysis, identify the resources necessary and any constraints involved, train employees on the new FSMA expectations, and be prepared to implement new and/or modify current policies and procedures to ensure inspection readiness.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

The Criminal Offensive Begins

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

FDA intends to pursue criminal investigations against any food company executives or quality assurance (QA) managers involved in cases in which a link is made between a positive sample collected by the agency from a food facility or product and a foodborne illness.

In fact, the agency and the U.S. Department of Justice just announced that they will be working together to aggressively enforce food safety laws, including the Food, Drug and Cosmetic Act. In prepared remarks at a food safety conference last week, Benjamin C. Mizer, principal deputy assistant attorney, indicated that criminal prosecution of food companies is a priority moving forward. “When it comes to food safety, we have to rely on the companies who manufacture and distribute food to ensure that the food we buy is safe,” Mizer stated in his remarks. “That is why food safety is a priority for the Justice Department.  Our role in protecting consumer safety is at its apex when consumers can least protect themselves.”

In addition, the FDA is exercising nearly limitless authority to access company records during an inspection and investigation—and in many cases doing so without a warrant.

The Park Doctrine. In 1975, the Park Doctrine solidified FDA’s authority to criminally charge corporate executives and high-level managers. The Supreme Court upheld the conviction of the president of a major grocery chain who was found to be criminally liable for unsanitary conditions existing in a company distribution center, notwithstanding the argument that he had delegated the responsibility for maintaining the cleanliness of the site to his subordinates. The Supreme Court concluded that if a company ships adulterated food, the management of that company can be charged, even if they have no direct knowledge or intent. Under this standard, a food industry executive or QA manager can be sentenced to prison if he or she is aware of a circumstance or condition within his or her facility that could lead to a foodborne illness and fails to take action to correct it. If charged with this type of misdemeanor, the executive could be sentenced to up to a year in prison and a $250,000 fine for each count. On a case-by-case basis, FDA will consider the individual’s position within the company, his or her relationship to the violation, and whether in fact he or she was in a position (or had the authority) to correct the violation. The government is demonstrating that it intends to use criminal sanctions to create a deterrent and compel compliance.

Peanut Corporation of America (PCA): Salmonella outbreak (2008). PCA owner Stewart Parnell was sentenced to 28 years in prison for knowingly selling peanut products contaminated with Salmonella. His brother, a peanut broker, was sentenced to 20 years, and Parnell’s QA manager was sentenced to five years.

Quality Egg: Salmonella outbreak (2010). Quality Egg distributed products linked to a Salmonella outbreak that sickened more than 1,000 people. Company executives did not know that their products were sickening consumers but were nevertheless cited by FDA for failing to control Salmonella in the growing and processing  environment.  When the outbreak was over, FDA conducted a criminal investigation, and company executives were sentenced to three months in jail and slapped with significant fines for food safety violations.

Learn new and innovative approaches to Listeria detection & control at Food Safety Tech’s workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MOREJensen Farms: Listeria monocytogenes (2011). The company distributed cantaloupe contaminated with Listeria monocytogenes and, over a two-month period, the tainted product sickened nearly 150 people and killed more than 30. Company owners were unaware of product contamination, but federal prosecutors brought criminal charges against the company regardless, arguing that Jensen Farms failed to take appropriate steps to reduce Listeria contamination in its facility. Company owners were sentenced to five years’ probation, six months’ home detention, 100 hours of community service, and assessed individual fines of $150,000.

ConAgra: Salmonella (2006­–2007). In 2014 FDA urged criminal charges be brought against ConAgra for distributing Salmonella-contaminated peanut butter, which sickened about 700 people, between 2006 and 2007. The company pled guilty to the charges and paid more than $11 million infines.

On May 2, 2014 FDA announced its intent to pursue “[c]riminal prosecution for falsifying records, lying to FDA, knowingly putting consumers at risk, or in other appropriate cases.”

Blue Bell: Listeria monocytogenes (2010–2015). In 2015, Blue Bell Creameries was linked to an outbreak in which FDA connected positive samples from those taken at retail and those taken at production facilities to seven case patients in the CDC database who carried the same strain of Listeria. Last year the agency urged the company to recall all of its products. What’s most concerning about the investigation is the fact that the first people who became sick fell ill more than five years ago (January 2010); two more illnesses were recorded in 2011, followed by one in 2012, and three in 2014. The final illness was reported January 2015.

The U.S. Department of Justice (DOJ) confirmed that FDA and the DOJ are making criminal sanctions “a priority” when companies “fail to live up to their obligations to protect the safety of the food that all of us eat.” The DOJ, working with FDA, has served federal grand jury subpoenas to Blue Bell, and is likely scanning food company records and executive emails to justify any criminal charges. If criminal charges are indeed brought against Blue Bell, FDA will likely argue that the company was periodically finding LM in its facilities over the past five years and failed to take sufficient action to correct the condition, which (as proven by the seven matching cases in PulseNet ),  resulted in human illness. Although this seems like an extreme approach, given the ubiquitous nature of LM, it is the approach the agency is aggressively pursuing.

Chipotle Mexican Grill: Norovirus (2015). For several months last year, Chipotle was unable to contain and manage numerous foodborne illness outbreaks. In a public filing the national restaurant chain confirmed that it received a federal grand jury subpoena from the DOJ in connection with a norovirus outbreak that occurred at a location in which more than 200 customers became ill.

According to reports, Chipotle executives became aware that numerous employees had reported being sick in August 2015, yet they waited a few days before informing the local health department of the illnesses and closing the restaurant. In turn, it appears that FDA and the DOJ initiated a criminal investigation and served the grand jury subpoenas in order to gain access to corporate emails and determine whether company executives waited “too long” after learning about the illnesses to take action. On January 28, officials from Chipotle confirmed that the restaurant chain was served with a subpoena that broadened the scope of the initial criminal investigation by the U.S. Attorney’s office for the Central District of California. This subpoena requires Chipotle to produce documents and information related to company-wide food safety matters dating back to January 1, 2013, and supersedes the subpoena served in December 2015 that was limited to a restaurant in Simi Valley, California. Although FDA is trying to uncover how the recent outbreaks occurred, the agency is also engaging in a broader “fishing expedition” to determine whether there is further justification to bring criminal sanctions as a result of any of the company’s broader food safety conduct.

Multiple Non-public Cases

The DOJ, in cooperation with FDA, is currently pursuing criminal investigations against many other companies connected to other reported illnesses. As these are ongoing investigations, the underlying facts cannot be disclosed publicly. However, the most important lesson to be learned is that food companies must be prepared to better control pathogens in their environment in order to protect themselves from criminal prosecutions. My subsequent column will discuss these strategies.