Tag Archives: foodborne illness

Listeria

Four Pathogens Cause Nearly 2 Million Foodborne Illness Cases a Year

By Food Safety Tech Staff
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Listeria

The CDC estimates that Salmonella, E. coli O157, Listeria monocytogenes and Campylobacter cause 1.9 million cases of foodborne illness in the United States. A report just released from the Interagency Food Safety Analytics Collaboration (IFSAC) analyzed data from more than 1000 foodborne disease outbreaks involving these pathogens from1998 through 2013.

The report found the following:

  • Salmonella illnesses came from a wide variety of foods (more than 75% came from the seven food categories of seeded vegetables, eggs, chicken, other produce, pork, beef and fruit.
  • More than 75% of E.coli O157 illnesses were linked to vegetable row crops, like leaf greens, and beef.
  • More than 75% of Listeria monocytogenes illnesses came from fruits and dairy products.
  • More than 80% of non-dairy Campylobacter illnesses were linked to chicken, other seafood (i.e., shellfish), seeded vegetables, vegetable row crops, and other meat and poultry (i.e., lamb or duck).

A copy of the report, “Foodborne illness source attribution estimates for 2013 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States”, is available on the CDC’s website.

Stephen Ostroff, FDA

FDA’s Ostroff Says Foodborne Illness Still Resistant to Change

By Maria Fontanazza
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Stephen Ostroff, FDA

“Everything changes; nothing remains without change.” It’s the Buddha quote that Stephen Ostroff, M.D., FDA deputy commissioner for food and veterinary medicine, used to kick off his plenary presentation at this year’s Food Safety Consortium. Yet “there is one thing that is stubbornly resistant to change,” he commented, and that’s foodborne illness. The incidence of culture-confirmed human infections hasn’t improved, and it can be seen in the number of cases reported through CDC’s FoodNet system. Why?

Stephen Ostroff, FDA
FDA’s Stephen Ostroff, M.D. answers audience questions during a town hall meeting at the 2017 Food Safety Consortium.

Ostroff has a few theories. First, there are much better diagnostics and surveillance systems in place versus 10 or 20 years ago. “Those improvements in finding the cases may be masking improvements that have occurred,” he said. Second, looking at the data from the big picture perspective may mask positive sub-trends. “We are actually doing better,” Ostroff said. “Within the data, there is some good news and some bad news.”

Ostroff also proposed that emerging food safety risks are having an impact on the rates of foodborne illness, including new trends that are altering the food landscape. The global food supply is more diverse than ever. In addition, the change in consumer preferences and eating patterns may lead to gravitation towards higher risk foods that are improperly handled. Other areas of risk include new methods of food delivery (i.e., e-commerce—Ostroff added that within a few years, up to 20% of our food will be delivered to our homes.). The final risk he touched on was new food types, such as synthetic foods (i.e., synthetic meat). “Nobody is quite familiar with the potential hazards associated with those foods,” he said.

FSMA Update

Over the past year, a new administration has come into place, along with a new FDA commissioner. In addition, compliance dates for six out of the seven foundational rules are now in effect (the compliance date for the Intentional Adulteration rule is July 2019). Although the new administration is focused on reducing the regulatory burden, it doesn’t appear to be impacting FSMA requirements. “To date we have no requests to change or delay FSMA requirements,” said Ostroff. “And that’s very good news.”

Third-party certification program. In June FDA launched a website through which organizations could apply to be recognized as an accredited body. Ostroff said the response and interest related to the program has been “overwhelming”, with hundred of entities visiting the agency’s website to learn more.

Voluntary Qualified Importer Program (VQIP). The agency anticipates that the application window will open January 2018 (however, Ostroff hinted that it may be delayed a bit). October 2018 is the projected start of the first benefit period.

FSMA Fixes. “There have been quirky issues that ended up in the FSMA regulations either because of the way FSMA was written by Congress or because of the way the regulations ended up,” said Ostroff, who added that the most problematic “quirk” is the intersection of whether an entity must comply with the Preventive Controls rule or the Produce Safety rule, and it all comes down to the farm definition. As a result, the agency extended compliance dates for a number of situations, one of which involves the agricultural water provision (January 2022 for large farms, January 2023 for small farms, and January 2024 for very small farms). Related to this provision, FDA is looking to reducing the regulatory burden but will keep standards in the lab analytic methods, frequency of testing and determination of water quality.

Training. The FDA has been partnering with many entities around the world to implement FSMA training both for industry and regulators. More than 50,000 people have been trained for the Preventive Controls for Human Food rule and more than 5000 have been trained for the animal food rule.

Inspection. At last year’s Food Safety Consortium, there was a lot of chatter about agency enforcement and inspection. Although Ostroff didn’t touch on enforcement, he provided a few figures on inspection activity for fiscal year 2017:

  • Preventive Controls for Human Food
    • Modernized CGMPs: 720
  • Preventive controls: 165 (46 outside of the United States)
  • Preventive Controls for Animal Food
    • CGMPs: 220
  • Foreign Supplier Verification Program: 285
  • Produce safety rule: 8 (sprouts)
Cara Pahoyo

5 Burning Questions About The Rise In Foodborne Illness

By Cara Pahoyo
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Cara Pahoyo

The food industry has been one of the most celebrated and fastest-growing industries over the last decade or so. Which is no surprise, considering how much food is now being consumed, or posted on Instagram, on a daily basis. Pop-up food carts and hole-in-the-wall food places have been a huge hit too and even inspired a number of Hollywood films about the tough competition and revolutionary marketing tactics that have taken over the food industry (see: Jon Favreau’s Chef and Bradley Cooper’s Burnt). It’s good times, for sure. Well, for the most part, I mean.

When did foodborne illness become a major concern in the US?

Unfortunately, it’s not just the revenue that’s on the rise, because food borne illnesses too are making the headlines as of late. Talk about spoiling (no pun intended) the fun, eh? Well, according to the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, the number of foodborne disease outbreaks resulting from imported foods increased during surveillance years 2005 to 2010.

Where are the numbers coming from?

Dr. L. Hannah Gould, Ph.D., a senior epidemiologist at the CDC, revealed those findings during an oral presentation here at the International Conference on Emerging Infectious Diseases in 2012. According to the CDC, 39 foodborne disease outbreaks were reported in which the implicated food had been imported into the United States. These outbreaks resulted in 2348 illnesses, 434 hospitalizations and 3 deaths.

How many are affected?

Though foodborne illnesses are often never formally reported, about 48 million Americans, or one in six, get sick each year from food, the CDC estimates, with 128,000 hospitalizations and 3,000 deaths. In fact, in 2014, 19,542 cases of infection were traced from 15% of the US population being surveyed by CDC.

Why is it on the rise?

The culprits? Chances are, you’ve been storing them somewhere inside your establishment: packaged caramel-coated apples, frozen ice cream sandwiches, fresh peaches and nectarines, frozen meet, etc. Not exactly the answers you were expecting, perhaps?

According to experts, the growing popularity of packaged foods such as pre-cut fruit and prepared sandwiches has heightened the risk of spreading foodborne illnesses. Furthermore, they have identified that contamination can occur between preparation and packaging, or in high-tech processing plants, after heating to destroy harmful bacteria and before packaging. Which means, somewhere in the last decade, we lost our way (or something like that).

What can we do to stop foodborne disease from spreading?

The whole fiasco regarding foodborne illness is a public safety concern and must be addressed by everyone. However, while adjusting individually may not be a problem for most of us, the same cannot be said for food places and restaurants. Just imagine the public relations horror for restaurant managers if any of their customers get sick while dining at their place?

Restaurants must be more strict and thorough when addressing food safety concerns. The entire crew must be trained when it comes to food handling and a food safety manager must also take charge in overseeing procedures in the kitchen. In fact, proper storage and disposal must also be adequately done at all times. With those safety measures in play, establishments will be able to showcase their commitment to adhere with local food standards and basic food handling procedures. That’s a step in the right direction, for sure.

Summing up, foodborne illness is definitely a manageable concern and will likely not become a factor that will hinder the overall growth of the food industry. However, the fact that it can be controlled and yet still recurring means that there’s still a fair amount of work needed to be done to improve the industry in other aspects—and that isn’t necessarily a bad thing (at least not yet).

Jordan Anderson, PAR Technology Corp.
FST Soapbox

How the IoT Influences Restaurant Food Safety & Management

By Jordan Anderson
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Jordan Anderson, PAR Technology Corp.

The Internet of Things (IoT) is changing the way restaurants do business in 2017. Today, business owners can trace products from point-of-purchase to their doorstep using IoT devices that monitor their location and more importantly, their temperature along the way. These devices are helping keep food safe, streamlining inventory management and giving owners the real-time information they need when managing multiple locations.

Monitoring Food Safety

Nothing gets the attention of a restaurant owner quicker than a foodborne illness outbreak. When it happens, they need to know which products were involved.

IoT devices allow owners to track their food from the time they order to the time it arrives. Even in the back of a tractor-trailer rolling down the highway, owners can check to see the temperature of their food, and can obtain the data trail during its entire journey to see how it was handled, and to ensure safety standards were met.

This data is especially important since the U.S. Federal Government enacted the Food Safety Modernization Act (FSMA) in 2011, which intends to protect public health by reinforcing the U.S. food safety program. Food-based businesses are now required to establish preventative control systems modeled after HACCP (Hazard Analysis and Critical Control Points) guidelines and prove their compliance by maintaining at least two-years of documentation.

Traceability measures utilizing IoT efficiently gathers and manages this information, giving owners the peace of mind they need to ensure their food has been handled properly. Not only that, but they have the data to prove it.

Inventory Control and Management

IoT devices help manage the cost of inventory by providing the real-time data that owners need when ordering stock and forecasting needs based on their menu. The data collected by the IoT devices ensures the freshest ingredients are available for dishes, and expired products are disposed of properly.

Tracking inventory from farm-to-fork prevents food waste, deters in-house theft and helps manage the cost of inventory.

Other questions and action items that IoT devices can help manage include:

  • Who placed the order, authorized the purchase, and accepted the delivery?
  • What was ordered and what are the products’ proper temperature ranges?
  • When did the order take place and when did it arrive? When is its expiration date?
  • What is the origin of the product and how did it travel to get to you?

This can help specifically within the restaurant retail market where pick-up and deliveries are becoming more prevalent.

For example: If a customer changes their scheduled pick-up, or drop-off times, retailers must have technology in place that will monitor food safety best practices. Deli, produce and dairy related products could use pre-determined checklists that will verify items were picked correctly, bagged properly and temperatures are checked to FDA regulated standards. While FDA regulations pertaining to FSMA are stricter than ever, it has never been more important for food safety technology to be integrated within the adoption of omnichannel restaurant practices. The likes of digitalized checklist management, temperature control and traceability will have a tremendous impact on continued growth and service within the marketplace.

IoT Devices and Temperature Control

Utilizing the IoT is a critical aspect of quality control. These devices are equipped with a temperature probe, barcode scanner and RFID infrared temperature reader that monitors and tracks your food throughout its journey in the supply chain.

Here’s how it works:

  • The probe, infrared and RFID scanner track and measure the temperature of each product.
  • The IoT software prompts employees to complete checklists, including temperature checks on a regular basis.
  • Each time the data is collected, it is immediately uploaded to a secure cloud and is accessible anytime, from anywhere.
  • While in the cloud, you can customize, store, filter and analyze the information.
  • Users are alerted immediately if any steps are overlooked, like non-observed items, missed checklists and violations, in addition to any corrective actions that address temperature concerns.
  • Should an issue arise, you have the detailed, automated audit trail to prove your company followed proper food safety protocol.

IoT Devices Can Create Modern Dining Experiences

Aside from helping to streamline and manage day-to-day operations, IoT devices can create a unique dining experience for your customers.

For example, if you love seafood – some restaurants are using IoT devices to track where and when seafood is harvested. One example of this kind of initiative is the Boat-to-Plate project funded by a grant from the Mid-Coast Fishermen’s Association. This project developed an app for anglers to upload information regarding their catch. Restaurant owners are using IoT information like this to create unique dining experiences.

IoT and You

How do you plan to use IoT technology in 2017? Integrating IoT practices gives your business the food safety solution needed to help keep food safe, improve supply chain traceability, manage your inventory and gain better control over your bottom-line.

Roslyn Stone

The Changing Landscape of a Foodborne Illness Outbreak Response

By Roslyn Stone, MPH
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Roslyn Stone

Recent high-profile foodborne illness outbreaks appear to have an enduring impact for the entire industry – from when and how health departments respond to alleged illness to how a single tweet wreaks havoc. The bar for when a comprehensive response is required is lower and the extent and nature of the required response has changed.

Here’s what we’ve learned:

Health departments are receiving more complaints from consumers. Although much of this is believed to be related to the high-profile outbreaks, some are a result of health department websites making it easier to report illness. A few years ago, guest illness reporting required calling the health department during business hours, working your way through complex voicemail options until you reached a recorded line to leave a message about your illness. Today, most health departments in large cities and many in smaller counties, have simple on line reporting systems available 24/7. So when someone isn’t feeling well at midnight, and is sure it’s from the last thing they ate, they go online and report the illness.

Health departments are now more often following up on single reports of illness and reports of illness that are inconsistent with most foodborne illness incubation periods. This is creating a large burden for already short-staffed departments, but in response to what the public now expects. In the past, they might have replied to the ill guest and explained that they’d received no other reports, that most foodborne illness has a longer incubation period and refer the illness to personal physicians if a follow up is clinically appropriate. But today, we’re finding many health departments dispatching inspectors for even a single complaint that doesn’t appear consistent with incubation periods for that meal.

There’s increasing pressure on health departments to go public with illness events – even if the illness is no longer ongoing or creating a public health risk. The foodborne illness legal community has made it clear that they believe the public has the right to know about any and every foodborne illness. And some health departments are responding to that pressure – without their being an on-going public health risk; which would have been the trigger in the past.

Guest complaints about illness are occurring more frequently. Every single one of our clients is reporting an on-going uptick in guest reports of illness. We’re not clear if it’s that consumers are more aware of illness, more concerned or more likely to associate it with a restaurant or food service provider. But the entire industry is seeing an increase in guest reports of illness. And every guest assumes it was the last meal they ate.

How you handle any guest complaint about illness is even more critical than it was a few months ago. Here’s why: if you don’t’ respond to the guest quickly and listen with authentic empathy, that guest is far more likely than ever before to tweet about you, write a bad review, post on social media or contact the media. You need to act quickly and it doesn’t matter if it’s a weekend or holiday. Waiting until Monday morning is not an option.

Noro season is year-round now… it’s no longer the winter vomiting disease like it is called in some places. Noro virus outbreaks continued in California (and elsewhere) until after the school year ended. We need to be alert to Noro all of the time.

Fourth of July
Fourth of July was an unusually quiet day in the restaurant, quieter than anticipated (meaning more prep done than needed). The next day, two employees called out sick. A day later, two guests (small parties) called the restaurant reporting illness and later that day, two more larger parties emailed their reports of illness through the corporate website. It took another 24 hours to match these multiple illness reports through three different channels. It didn’t trigger a full-blown response and implementation of the noro sanitizing protocol.
THE FINAL TALLY: 40+ guests reporting sickness and nearly half of the staff.
THE LESSON: Coordination of reporting mechanisms so that you see a potential problem and respond at the earliest point when you can have the greatest impact in minimizing risk.

Employees continue to work sick. There are so many reasons that employees work sick and it has little or nothing to do with paid sick time. They work sick because they’re not very sick, they don’t understand that any gastrointestinal upset may be a sign of foodborne illness, they don’t want to disappoint their manager or they don’t want to let their team down. They’re working sick for altruistic reasons without understanding the potential ramifications. We have a long way to go in educating managers and employees about what “sick” looks like, what can happen from working sick and why we need to work together long term to change this set of behaviors.

Employee Exclusion Policies need to be revisited. Someone is shedding the Noro virus for twenty-four hours prior to become symptomatic and then at very high levels for three days after symptoms end. Sick employees need to be excluded for much longer than they currently are in most restaurants and food service establishments to control Noro outbreaks.

Employee Illness on Days Off are as critical to crisis prevention and response as illness on work days. You need to know if an employee was sick on a scheduled work day or on a day off. As we discussed previously, they were shedding the Noro virus before they got sick and for days after. Your illness response plan needs to include a very robust tool for employee illness reporting – one that is as easy to use seven days a week and raises an alert to management when there are two or more sick employees.

It’s time to redraft and recommunicate the definition of a potential crisis in your organization. In the past, we previously used the following definitions of what defined a potential crisis for a restaurant or foodservice group:

  • Two or more employee illness reports (for same time period and symptoms)
  • Two or more guest complaints (from different parties for same time period)
  • One confirmed employee illness (with a communicable disease)

Your new definition must be broader and reflect the lower trigger points for action. It may include one guest complaint from a large party, illness in a neighboring school, social media buzz about illness from your location and / or a health inspection in response to a guest complaint of alleged illness.

The takeaway: the lessons learned continue to evolve and new ones emerge with each new outbreak. Making sure we identify and share these lessons across the industry and your organization is critical for being prepared to first identify and then quickly respond to the next threat that comes your way.

Stanley Rutledge, Stop Foodborne Illness
Food Safety Culture Club

What’s the Point?

By Stanley Rutledge
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Stanley Rutledge, Stop Foodborne Illness

I’m surprised when I meet people who ask me, “What’s the point?”

What’s the point of…contacting people who’ve been impacted by foodborne illness? Sharing those peoples’ stories with industry?

Turns out, most of these people are speaking out of inexperience. For them, foodborne illness is a day or two spent home in bed, or the bathroom. They honestly aren’t aware that every year, for the families and friends of 3000 people*, foodborne illness is a destructive force much like the recent hurricane. It forces many people out of the lives they’re living into dire, and often extreme, situations where they’re required to rely on strangers and others for help. And before they reach a “new normal”—whatever that means—they face a myriad of physical, mental, financial, and social consequences. Unlike the hurricane, however, people who are victims of foodborne illness get no advance warning and are powerless to stop its effects, or even prepare for them.

At Stop Foodborne Illness we know the transforming power of story—of being able to recount an experience so powerful that it set you on a path different from where you started. For us, sharing those stories on an industry level is empowering for everyone involved. I’m always saying that everybody knows they need to wash their hands, but when that knowledge transitions from your head to your heart, then you have habits changing and behavior being modified.

Last month, a constituent from Wisconsin had the opportunity to share her story with about 120 employees of a fruit processing plant also located in Wisconsin. The following is an email we received afterwards that so clearly explains why we do what we do at Stop:

“You did an absolutely wonderful job. The impact on the group was exactly what I had hoped. Rest assured that you are making a difference by telling your story, and I know that was emotional and hard for you. Many people came up to me and said how different it makes them think of things now, having heard someone speak so close to home that almost died.

I can’t thank you enough.”

*The CDC estimates that every year in the United States, 3000 people die from foodborne disease, and that 128,000 people are hospitalized.

Randy Fields, Repositrak
FST Soapbox

Update: Non-FSMA Food Safety Litigation

By Randy Fields
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Randy Fields, Repositrak

The keynote panel at the 2017 Food Safety Summit in May had, as any food safety professional would expect, a focus on how companies are coping with FSMA and the increased scrutiny they may face. There was unanimous belief on the panel that enforcement is coming and all trading partners need to be prepared, but there was also a look beyond FSMA adoption to what will come next.

First, though, where do we stand with FSMA-related litigation?

Shawn Stevens, one of the leading food industry lawyers, told attendees that it’s important for all retailers, wholesalers, suppliers and affiliates to understand that FDA was commanded by Congress to stop foodborne illness and the impact it has on Americans, plain and simple. His advice is for food pros to learn all aspects of FSMA and do it quickly, saying the goal now is to avoid making the operational mistakes that may result in criminal exposure for the company and its executive leadership team.

Going forward, the industry will not only have to comply with FSMA, but it will also need to address recalls, risk mitigation and other complex food safety issues not directly related to FSMA. Foodborne illness outbreaks will still cause legal claims that can be compounded by personal injury suits and potentially impact a retailer’s reputation negatively. Also, there are trends in organic foods, GMOs, gluten-free items and more that will impact the retailer, supplier and ultimately may result in more litigation.

Jeffrey Steger, assistant director of the Consumer Division at the U.S. Department of Justice (DOJ), reported that companies shouldn’t expect a waning of the federal government’s support of non-FSMA enforcement actions. The DOJ gets involved in cases where there is significant harm to consumers, where food company executives had prior knowledge, and where legal action will protect the integrity of the regulatory system and prevent future harm. It has pursued many high-profile food industry prosecutions to date and he believes this trend will continue.

The importance of the FSMA regulations and the responsibilities placed on the food industry shouldn’t be understated in the context of food-related litigation. But there are other new developments in the marketplace and the extended supply chain that are impacting retailers like transparency in packaging, labeling of social responsibility programs, the move toward clean labels and facility auditing requirements.

Recent research by the Food Marketing Institute indicates retailers and suppliers that connect with shoppers in support of food safety are well positioned to build shopper trust and loyalty. The converse must also be true—companies that have their reputation dragged down due to involvement in food safety litigation will surely be poorly positioned to build shopper trust and loyalty.

Retailers and suppliers need to address all food safety-related issues or risk becoming defendants in a lawsuit or further government regulation. To accomplish this goal and, more importantly, to keep their customers safe, food companies need to nurture an enterprise-wide food safety culture that extends from the executive suite to store personnel –all retail employees must be responsible for food safety. Only then will customers recognize the company as being committed to food safety, and only then will the company get ahead of any potential food safety-related litigation.

Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

How Do We Incentivize Behavior Change?

By Deirdre Schlunegger
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Deirdre Schlunegger, CEO of STOP Foodborne Illness

In March, I presented and participated in a session regarding produce safety at The Global Food Safety Conference in Houston. In April, I was the keynote speaker at the BRC conference in Orlando, Florida. I asked: What incentivizes the human spirit and how do we draw on people’s creativity and their ability to have empathy and to solve problems?  Which interventions are more or less likely to stimulate one’s ability to care about food safety as it relates to human beings? Knowledge alone seldom changes behavior. The imagination benefits from stimulation—for example, listening to personal stories. For change to happen, there must be an emotional connection to the idea of achievable outcomes.

This past year we spoke at a large food company. During a pre-call to discuss what the presentation might look like, one man said that nearly 20 years ago, he heard Nancy Donley speak about her son Alex, who died at the age of six from a foodborne illness. He said since that time, he has never looked at food safety the same way, and he takes every single infraction dealing with food safety as a possible consequence for someone’s life. A rational understanding of what a better outcome might look like will often involve a deeper understanding and a connection with an issue and with the individuals related to that issue. Change is difficult. We often don’t learn until we risk collapse or fail. In a moment of crisis, we are presented with a unique opportunity for change. This idea could stand to be finely calibrated, as there are moments that are too painful to activate learning as one struggles with a deep sense of hopelessness, and there are moments when change lies outside the realm of possibilities. An analytic perspective without access to emotional content is unlikely to provide the conditions for change, but a link between the head and the heart may initiate transformation.

I met Will Daniels, formerly of Earthbound Farms after an emotional presentation he made at a conference. He spoke about a young boy who died from the spinach outbreak and he referred to his children of nearly the same age. He also presented the sequence of events that led to and followed the outbreak in a very factual and logical way. This link between his head and his heart delivered a presentation that was impactful, emotional, factual and sincere. A cold analysis of a problem is seldom sufficient, nor is the condition of people when they are stuck in an overwhelming emotional state. The challenge is to find middle ground and put together thinking and feeling in a context where a coherent narrative will be created. For individuals to change their behavior, we must influence not only their environment, but their hearts and their minds. What we do know about change and people’s readiness to change is that it has much to do with timing and ripeness. The crucial question is whether issues are close enough to the surface to break into the public discourse or to have an impact on a system. As a protective mechanism, people resist the pain of engagement and hold onto old assumptions, often adopting a deluded narrative. People may find that blaming others, scapegoating, externalizing the other party, denying the problem, jumping to conclusions, or launching a distracting issue might restore stability and feel less stressful than facing and taking responsibility for a complex challenge.

We often see change in companies and their policies after they have experienced an outbreak, not before. Over the years we have seen this with several companies whose confidence was high prior to an outbreak, as they had never had a problem before and felt as if they were immune. The challenge is to allow for conditions in that there is sufficient pressure to change but there is also a safety net in place. There is a real tension between the pressure to change and the conditions that allow for necessary creativity, flexibility and imagination to get us through a crisis.   Businesses that are transparent in their admittance to a problem often are better able to create change in a safe environment. In other words, “yes, we have a problem and what are we going to do to change course?” Crisis isn’t necessary but in reality, catastrophic events often precede modifications in policy and practice. Creating a head/heart connection during planning and training may deliver a sense of urgency to help individuals remember “the why” behind food safety.

Until we prepare for a future with a sense of urgency and commitment and fully integrate “the why behind food safety”, we will merely repeat errors of the past. It takes courage and true leadership to carry out a vision, a future that doesn’t deny or divorce itself from the past but uses it in such a way that opens the door to progress. We have improved our narratives and are better at risk analysis and detection, and I believe we will continue to improve.

Department of Justice seal

Seeking Deterrent Effect, DOJ Targets Cases that Have Big Influence

By Maria Fontanazza
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Department of Justice seal

As the Department of Justice (DOJ) continues to prioritize prosecution against food companies that have been involved in recalls and foodborne illnesses, many often wonder how exactly the department decides which companies it will pursue and why. The most notorious recent example is the case against the Peanut Corporation of America (PCA) in which the sentencing of the company’s executives was said to have set a precedent for the industry. One of the reasons the DOJ went after PCA was due to its widespread distribution of food and the fact that the illnesses and deaths were all over the country, according to Michael Blume, director of the consumer protection branch of the DOJ.

“Did any of you hear about [PCA] before the outbreak?” Blume asked the audience at the GMA Science Forum last week. “Consumers have very little ability to protect themselves from foodborne illness. PCA was in all kinds of brands—crackers, Kelloggs, [etc]. For those reasons, we were much more concerned about preventing these kinds of outbreaks and what could the DOJ do about it.”

When assessing contenders for criminal prosecution, there are several common factors that encourages the DOJ to dig deeper:

  • The amount of harm. Has the sale of contaminated food has led to a great deal of illnesses or deaths?
  • Has the company had problems in the past? If it is a first time occurrence, the DOJ is less likely to pursue a case, but if there is a history, “we’re going to look harder,” said Blume. For example, if a government agency or another party has identified a problem, and then the FDA also sees the problem and issues a 483. Then five years later, the company still has not fixed the problem.
  • Similarly, if the DOJ sees that the company has identified internal problems and has chosen not to fix them, and as a consequence, these actions lead to the sale of contaminated food.
  • Where does the company sit in the market? “We can’t [pursue] every case, we have to think about what case will be most impactful,” said Blume. “What case will signal to the rest of industry that there are things they need to think about? If it is a company that people think have a good reputation, etc—to give a signal to industry—there are things that even the very best in industry can run afoul.”
  • If there’s evidence that the company has misled any party. This doesn’t apply to a government body only—it could also be the company’s vendors.
  • The general culture. Although this concept is intangible, the DOJ considers a company’s reputation in the industry and the relationship it has with regulators. Are they trying to fix issues and maintain compliance? That will make a difference and will be weighed in the company’s favor versus companies that choose to ignore problems.

“The DOJ thinks very hard about charging individuals. If there’s a criminal investigation targeting a company, you have to be concerned about who acted within the company and what their role was.” ­– Michael Blume, DOJ

Of course, food companies would like to avoid the heavy hand of the DOJ and for that, Doug Fellman, partner at Hogan Lovells US, LLP, offered several points of advice:

  • Be on guard for red flags that suggest a compliance-related environment in which the company is at risk for having problems. If employees are raising concerns at the facility or about the manufacturing process, don’t let people write those individuals off.
  • Be careful about how any decisions will look in hindsight. Stop on a real-time basis and look at how it will appear in retrospect.
  • If in a recall situation, decisions must be made quickly. Be careful that any decision making won’t to come back and bite the company when someone looks at it with the benefit of time.
  • Always be truthful and candid with the regulators.
  • Ask yourself whether you really know the conditions at the facility. Do people have visibility to what’s happening there?
  • Beware of emails. “Emails form the basis of almost every case I have,” cautioned Fellman.

Should the DOJ show up at your facility, it’s important to be polite and act professional towards agents. Although this may seem obvious, whether or not the agents immediately encounter pushback makes a difference, advised Blume. That said, it’s important to have protocols in place in the event that the DOJ shows up either at a company facility or even at an employee’s doorstep. “We get great evidence from a knock at someone’s door who doesn’t know what to say or when we do an inspection and people don’t know what to do,” said Blume. It’s prudent to discuss in advance when to seek the advice of a lawyer, because the more prepared a company is in handling such an issue, the less likely it is to make incriminating statements.

Reduce Foodborne Illness Causing Microorganisms through a Structured Food Safety Plan

By James Cook
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In 2011 three U.S. government agencies, the CDC, the FDA and the USDA’s Food Safety Inspection Service (FSIS) created the Interagency Food Safety Analytics Collaboration (IFSAC). The development of IFSAC allowed these agencies to combine their federal food safety efforts. The initial focus was to identify those foods and prioritize pathogens that were the most important sources of foodborne illnesses.

The priority pathogens are Salmonella, E. coli O157:H7, Listeria monocytogenes and Campylobacter. To research the most important product sources, the three agencies collaborated on the development of better data collection and developed methods for estimating the sources of foodborne illnesses. Some of this research was to evaluate whether the regulatory requirements already in effect were reducing the foodborne pathogens in a specific product matrix. The collection, sharing and use of this data is an important part of the collaboration. For example, when the FDA is in a facility for routine audit or targeted enforcement, they will generally take environmental swabs and samples of air, water and materials, as appropriate, which are then tested for the targeted pathogens. If a pathogen is found, then serotyping and pulsed-field gel electrophoresis (PFGE) fingerprinting is performed, and this is compared to the information in the database concerning outbreaks and illnesses. This data collection enables the agencies to more quickly react to pinpoint the source of foodborne illnesses and thereby reduce the number of foodborne illnesses.

The IFSAC strategic plan for 2017 to 2021 will enhance the collection of data. The industry must be prepared for more environmental and material sampling. Enhancement of data collection by both agencies can be seen through the FSIS notices and directives, and through the guidance information being produced by the FDA for FSMA. Some examples are the raw pork products exploratory sampling project and the FDA draft guidance for the control of Listeria monocytogenes in ready-to-eat foods.

Starting May 1 2017, the next phase of the raw pork products exploratory sampling project will begin. Samples will be collected and tested for Salmonella, Shiga-toxin producing E. coli (STECs), aerobic plate count and generic E. coli. In the previous phase, the FSIS analyzed 1200 samples for Salmonella for which results are published in their quarterly reports. This is part of the USDA FSIS Salmonella action plan published December 4, 2013 in an effort to establish pathogen reduction standards. In order to achieve any objective, establishing baseline data is essential in any program. Once the baseline data is established and the objective is determined, which in this situation is the Health People 2020 goal of reducing human illness from Salmonella by 25%, one can determine by assessment of the programs and data what interventions will need to take place.

The FDA has revised its draft guidance for the control of Listeria monocytogenes in ready-to-eat food, as per the requirement in 21 CFR 117 Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Foods, which is one of the seven core FSMA regulations. Ready-to-eat foods that are exposed to the environment prior to packaging and have no Listeria monocytogenes control measure that significantly reduces the pathogen’s presence, will be required to perform testing of the environment and, if necessary, testing of the raw and finished materials. Implementing this guidance document helps the suppliers of these items to cover many sections of this FSMA regulation.

The purpose of any environmental program is to verify the effectiveness of control programs such as cleaning and sanitizing, and personnel hygiene, and to identify those locations in a facility where there are issues. Corrective actions to eliminate or reduce those problems can then be implemented. Environmental programs that never find any problems are poorly designed. The FDA has stated in its guidance that finding Listeria species is expected. They also recommend that instead of sampling after cleaning and/or sanitation, the sampling program be designed to look for contamination in the worst-case scenario by sampling several hours into production, and preferably, just before clean up. The suggestion on this type of sampling is to hold and test the product being produced and to perform some validated rapid test methodology in order to determine whether or not action must be taken. If the presence of a pathogen is confirmed, it is not always necessary to dispose of a product, as some materials can be further processed to eliminate it.

With this environmental and product/material testing data collected, it is possible to perform a trends analysis. This will help to improve sanitation conditions, the performance of both programs and personnel, and identity the need for corrective actions. The main points to this program are the data collection and then the use of this data to reduce the incidence of foodborne illness. Repeated problems require intervention and resolution. Changes in programs or training may be necessary, if they are shown to be the root cause of the problem. If a specific issue is discovered to be a supply source problem, then the determination of a suppliers’ program is the appropriate avenue to resolve that issue. Generally, this will mean performing an audit of the suppliers program or reviewing the audit, not just the certificate, and establishing whether they have a structured program to reduce or eliminate these pathogens.

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