Tag Archives: foodborne illness

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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I.M. Healthy SoyNut Butter, recall

Latest Count: 16 Ill, 8 Hospitalized in E. Coli Outbreak Linked to SoyNut Butter

By Food Safety Tech Staff
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I.M. Healthy SoyNut Butter, recall

According to the latest numbers from the CDC, 16 people have been infected with E. coli O157:H7 after reportedly consuming I.M. Healthy brand SoyNut Butter. 14 of the 16 people infected in the multi-state outbreak are younger than 18 years old; 8 people have been hospitalized, five of which developed hemolytic uremic syndrome; and no deaths have been reported.

Yesterday The SoyNut Butter Co. expanded its recall to all varieties I.M Healthy Soynut Butters and Healthy Granola products.

“Epidemiologic evidence indicates that I.M. Healthy brand SoyNut Butter is a likely source of this outbreak. I.M. Healthy brand SoyNut Butter may be contaminated with E. coli O157:H7 and could make people sick.” – CDC

Illnesses began on January 4, 2017 and continued to February 21, 2017. The CDC notes that it can take two to three weeks for a person to become ill, thus any illnesses that occurred after February 13 may not be reported yet. The center is advising consumers to throw out all of the recalled products and that childcare centers, schools and institutions refrain from serving these products.

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

Telling the Story of Foodborne Illness

By Deirdre Schlunegger
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Deirdre Schlunegger, CEO of STOP Foodborne Illness

If you are looking for someone who has been ill or has had family members who were ill or died from a foodborne illness to come and speak at your food safety training, give Stanley Rutledge or myself a call, or send us an email. Individuals want to tell their stories, they want to make a difference, and they want to have an impact.   The stories are powerful and their stories are “the why” behind food safety. People who have attended the trainings tell us they never forget the people they meet and the stories told—they think about them everyday in their work and especially when making decisions that impact food and public safety.

Tauxe, STOP Foodborne Illness
Deirdre Schlunegger of STOP Foodborne Illness presents the Advancing Science for Food Safety Award to Robert Tauxe, M.D., MPH, deputy director of the CDC’s Division of Foodborne, Waterborne and Environmental Diseases at the National Center for Emerging and Zoonotic Infectious Diseases.

In the fall, I was on a phone call with a man from Smithfield Foods. We, along with a few others from the company, were planning an upcoming training and speaking engagement. He said that he would never forget listening to Nancy Donley talk about her son, Alex. Dr. Robert Tauxe told me a similar story about hearing Nancy in a public forum talk about her son. Rylee Gustafson, recently through STOP Foodborne Illness, spoke at The Partnership for Food Safety Education and told her story. Now a college student, she spoke about the long-term impacts of her illness—the diabetes, the damaged pancreas, the voice and vision problems, and the high blood pressure. The room was silent and so many people came up to her afterwards to thank her for sharing.

These stories illustrate that this is real: It does happen and when the person who was involved is standing before you reliving their story, you Will remember! Of course, we have fact sheets and a lot of other information on our website for your use, but there is nothing that is more direct, thought provoking and memorable than listening. If you want to read some of the stories, visit our website.  You can contact Stanley at srutledge@stopfoodborneillness.org or me at dschlunegger@stopfoodborneillness.org

Thanks for all that you do for food safety!

Hank Lambert, Pure Bioscience

Tech Spotlight: How Chipotle Fights Norovirus

By Food Safety Tech Staff
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Hank Lambert, Pure Bioscience

Watch another video: Antimicrobial Technology Mitigates Pathogen Risk Throughout the Supply ChainChipotle was plagued with several foodborne illness outbreaks in 2015. Norovirus was one of them. As part of the company’s commitment to addressing its food safety issues, it enlisted the help of technology from Pure Bioscience. In the following video, Hank Lambert, CEO of Pure Bioscience, explains how and where Chipotle is using the Pure Hard Surface technology in its establishments to mitigate the risk of norovirus.

FDA on Enforcement: Our Goal is To Help, Not Punish

By Maria Fontanazza
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Over the past year and a half, much attention has been given the federal government’s commitment to prioritizing prosecution of food companies that engage in criminal behavior. In some instances, this has been used as a scare tactic, shining a spotlight on the executive responsibility of company executives.  Although focusing on executive liability isn’t necessarily a bad thing, Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, wants food manufacturers to know that FDA isn’t out to get them.

During yesterday’s opening keynote presentation at the 2016 Food Safety Consortium, Ostroff commented on FDA’s approach to enforcement. “I often have to scratch my head as why this has been such a tremendous concern in a regulated industry…sitting at FDA, we have not had any change in our thinking and approach about liability,” said Ostroff. “FDA pursues legal action against companies that are clearly negligent and clearly violating the law.” He emphasized that FDA’s goal moving into the FSMA compliance phase hasn’t changed; it’s about implementing a food safety system focused on preventive controls.

Ostroff encouraged attendees to look at the areas in which their food safety system is vulnerable, take proactive action and build redundancies into their system. “The best defense is to comply with the new requirements, and document how you are creating a food safety culture where everyone understands the expectations,” he added. “If you’re making a good faith attempt—our goal is to help you accomplish that goal, not to punish you for the attempts that you’ve made in good faith.”

The deputy commissioner also commented on the agency’s progress since FSMA’s seven rules were finalized in May, pointing out that these rules are foundational, and additional rules are to come. These rules will address lab accreditation, traceability related to imported products and a reportable food registry tool.

“If when we visit we identify very significant food safety hazards that we think pose an imminent risk of foodborne illness, we will have to take action.” – Stephen Ostroff, M.D.

Other key areas Ostroff discussed regarding agency progress and initiatives included:

  • Initial compliance date for FSMA Preventive Controls Rule (for large companies). FDA wants to be a partner in assisting companies with the preventive controls requirements. “That for us will require a lot of work on the part of those who are going to be conducting these inspections, but our goal is to help you and tell you in which areas you’re doing quite well and in which areas you can do better,” said Ostroff, adding that many of the aspects of the preventive controls rule are very similar to what many companies have already done.
  • Foodborne outbreaks. With several outbreaks in the 2015–2016 timeframe (ice cream–Listeriosis; cilantro–cyclospora; cucumbers­–Salmonellosis; Mexican-style fast food–E.coli O26; flour–E.coli O121), the Inspector General expressed concern over the FDA recall process and criticized the agency for not having  better defined timeframes. In response to that report, FDA implemented the SCORE (Strategic Coordinated Outbreak Response and Evaluation) team, which guides concrete action plans for measures that the agency must take in the areas of recalls, for example. The team consists of decision makers from key operations and enforcement offices with a goal of expediting the evaluation of compliance and enforcement options. Since April, SCORE has addressed flour contaminated with peanut protein, facilities contaminated with Listeria, Salmonella in pistachios, and baby food that was not manufactured in compliance with infant formula regulations.
  • Antimicrobial resistance. The issue is “getting attention at the highest levels of government,” said Ostroff, adding that the best way to address antimicrobial resistance is to not have to treat it in the first place—and to do this is through reducing the incidence foodborne illness. The agency is moving forward in several areas here, including addressing non-judicial use of food animals and veterinary settings; enhancing NARMS data and isolate collection; and collecting data on antimicrobial sales by species.
Attendees listen to Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, give the keynote presentation at the 2016 Food Safety Consortium.
Attendees listen to Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, give the keynote presentation at the 2016 Food Safety Consortium.

During the Town Hall part of the presentation, Ostroff was asked, with the finalization of the FSMA rules, are they cast in stone? His answer: Not necessarily. “It took five years to get in place…because we did it in a very systematic way with a lot of stakeholder input. When you put together rules that are this complicated, there’s no guarantee that you got everything right,” he said. “[We] have to recognize that sometimes some of the flaws don’t become apparent into you implement them. You always have to be of the mindset that if everything didn’t work out exactly the way things were anticipated…we always have to be open to the fact that as we move forward and implement the rules, we might have to make course corrections.”

STOP Foodborne Illness

STOP Shines Spotlight on Commitment to Fight for Safe Food

By Food Safety Tech Staff
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STOP Foodborne Illness

Last night STOP Foodborne Illness recognized food safety heroes for their dedication to food safety. The fundraiser was held during the 2016 Food Safety Consortium.

Jeff Almer, STOP Foodborne Illness
Jeff Almer received the Food Safety Hero award for his work in bringing attention to the Salmonella outbreak involving Peanut Corporation of America. The illness took the life of Almer’s mother. Almer received the award from Gina Kramer, executive director of Savour Food Safety International.
LGMA, STOP Foodborne Illness
Dan Sutton (left) and Scott Horsfall (right) accepted the Food Safety Training Award on behalf of California Leafy Green Marketing Association from Deirdre Schlunegger (middle), CEO of STOP Foodborne Illness.
Tauxe, STOP Foodborne Illness
Robert Tauxe, M.D., MPH, deputy director of the CDC’s Division of Foodborne, Waterborne and Environmental Diseases at the National Center for Emerging and Zoonotic Infectious Diseases received the Advancing Science for Food Safety Award.