Tag Archives: outbreaks

September 27, 2016

New Whole Genome Sequencing Test Monitors Threat of Pathogens

By Maria Fontanazza

Today food companies will have access to a new whole genome sequencing (WGS) test that could help them prevent dangerous pathogens from getting into their products. Released by Clear Labs, the test takes a detailed approach to identifying pathogen strains in samples, providing information about their geography and from which food groups they originate.

In an exclusive interview with Food Safety Tech, Mahni Ghorashi, co-founder of Clear Labs, explains how he expects the company’s new test, which has a five- to seven-day turnaround time, will offer companies with a more accurate yet less expensive alternative to protecting consumers by actively monitoring their supply chain for emerging pathogens.

Food Safety Tech: What differentiates this WGS test from current available solutions?

Mahni Ghorashi: No one has been able to provide the food industry with modern whole genome sequencing techniques for food safety. What we’re releasing is a quantum leap in terms of what’s been available on the market today. Whole genome sequencing has been largely siloed to regulatory bodies like FDA and CDC to trace outbreaks and inform investigations—the technologies and techniques that they’re using are actually fairly old; they’re some of the original WGS techniques that emerged on the next-gen sequencing platform. We’ve taken the most advanced techniques on the NGS platform for human disease exploration and personalized medicine and adapted them for food industry.

What gives our WGS test a competitive advantage over legacy-based methods is two fold:

1. Clear Labs has a 2-million+ entry-curated database of genomic information and sequences for the accurate ID of food ingredients (pathogenic organisms and microbiomes). Its accuracy and the confidence level that comes behind our matching is a huge step above anything that’s available in the public domain today.

2. Being able to place pathogenic strain information in the context of overall food ingredients and samples. The whole genome sequencing test we developed has been specifically catered for the food industry, and for food samples in particular, [versus] FDA’s GenomeTrakr, CDC’s PulseNet, or other food safety labs that are offering full genomic sequencing of pathogen strains—they’re using some of the earliest methods to do this. On the NGS platform, we’re able to put those strains in the context of food ingredients and suppliers: Specifically, [matching] bacterial strains with food ingredients [and] suppliers.

FST: Does this test target specific foods?

Ghorashi: Our platform particularly shines in complex foods. The value of next-gen sequencing and DNA barcoding over PCR-based technologies, which is the gold standard in food safety, is its stability to break down complex food ingredients into all of their known parts, and to look in a universal and unbiased way into food samples. It’s untargeted, so you don’t have know what it is that you’re looking for—and that’s the real power.

FST: What impact do you anticipate for this test, especially in the context of FSMA?

Ghorashi: Our customers are using [the test] for monitoring ingredient supplies and the effectiveness of preventive and sanitary controls [and] to match specific pathogen strains to specific food ingredients. They are using it for proactive testing for FSMA compliance—there’s a lot of movement in this direction and hefty budgets are being allocated to put new preventive controls in place in response to FSMA; whole-genome sequencing will play a big role, and we anticipate large-scale partnerships with agencies and private industry on that front. And the most obvious use case is that it’s being used for techniques to mitigate or reduce the risk of product recall and outbreak.

We’ve been able to significantly reduce the price point on whole-genome sequencing, and all of our tests across the board, because we’re intimately familiar with how the inner workings of these platforms and how to best optimize them for scale and cost efficiency. We think the test will be more accurate and leaps and bounds ahead of what’s available, as well as cost competitive. We’re excited about the work we’re doing and its impact on food safety. I don’t think the food industry—retailers and manufacturers—have ever had access to these kind of tools and they’re being made available just in time for FSMA, as the industry moves towards a more proactive approach to food safety and [takes] preventive measures in their supply chains. Hopefully we’ll soon be living in a world where outbreaks, illness and the financial toll are a thing of a past.

Clear Labs also just released a microbiome test that helps companies associate microbiomes with specific food ingredients.

Mahni Ghorashi: The microbiome test we’ve developed is able to sequence samples from the human gut and from food, and look at how the microorganisms are interacting. Our customers for this test have been large brands that have advanced R&D departments and academic research centers that are looking for how diet research and the microbiome interact together and how new product development can help us move toward personalized diets when it comes to prebiotic and probiotic diets.”

The impact of the microbiome and the correlations between bacteria of the human gut and the bacteria in the food we eat. The prevailing thesis at the moment is that the microbiome has a significant impact on our health when it comes to disease risk and diet, inflammation and mood disorders. We’re seeing very forward thinking brands like Nestle, ConAgra and Mars putting a lot of attention on the impact of the microbiome when it comes the development of new products, [such as] prebiotics and probiotics, or even specific food products as it pertains to the microbiome. We believe that this intersection— nutrigenomics and the personalized diet—is going to be a massive market, and we’re at the early stages of that.

August 11, 2016

IBM Research Uses Data to Accelerate Source of Contamination During Outbreaks

By Food Safety Tech Staff

No Comments

Using electronic retail scanner data from grocery stores, IBM Research scientists may have found a faster way to narrow down the potential source food contamination during an outbreak. Researchers from the firm conducted a study in which they were able to show that, using just 10 medical exam reports of foodborne illness, it is possible to pinpoint an investigation to 12 food products of interest in a only a few hours. A typically investigation ranges from weeks to months.

The study, “From Farm to Fork: How Spatial-Temporal Data can Accelerate Foodborne Illness Investigation in a Global Food Supply Chain”, demonstrated a new way to accelerate an outbreak investigation. Researchers reviewed the spatio-temporal data (i.e., geographic location and potential time of consumption) of hundreds of grocery products, and analyzed each product for shelf life, consumption location and the probability that the product harbored a pathogen. This information was then mapped to the known location of outbreaks.

“When there’s an outbreak of foodborne illness, the biggest challenge facing public health officials is the speed at which they can identify the contaminated food source and alert the public,” said Kun Hu, public health research scientist, IBM Research – Almaden in a press release. Rsearchers created a system to devise a list that ranked products based on likelihood of contamination, which would allow health officials to test the top 12 suspected foods. “While traditional methods like interviews and surveys are still necessary, analyzing big data from retail grocery scanners can significantly narrow down the list of contaminants in hours for further lab testing. Our study shows that big data and analytics can profoundly reduce investigation time and human error and have a huge impact on public health,” said Hu.

The researchers point of out their method isn’t a substitute for proven outbreak investigation tools but rather serves as a faster way to identify contaminated product(s). According to the study, researchers assert that their methodology could significantly reduce the costs associated with foodborne illness, outbreaks and recalls. Thus far IBM Research’s approach has been applied to a Norweigan E. coli outbreak in which there were 17 confirmed cases of infection. Public health officials used the method to devise a list of 10 potential contaminants from the grocery scanner data of more than 2600 products. From there, lab analysis traced the contamination source to batch and lot numbers of sausage.

The study was published in the Association for Computing Machinery’s Sigspatial Journal.

June 16, 2016

Study Makes Connection Between Outbreak Data and Foodborne Illnesses

By Food Safety Tech Staff

No Comments

Outbreak illnesses and sporadic illnesses have similar traits. In addition, outbreak data can be used to assess the foods that are most frequently connected to particular foodborne illnesses. This analysis, all according to a recent study by the Interagency Food Safety Analytics Collaboration (IFSAC), could aid in improving the progression of science as well as provide a better understanding of the role of sporadic foodborne illnesses and their relation to an outbreak.

Scientists from IFSAC published the paper, “Comparing Characteristics of Sporadic and Outbreak-Associated Foodborne Illnesses, United States, 2004-2011”, in a July 2016 issue of Emerging Infectious Diseases. They collected data from the CDC’s Foodborne Diseases Active Surveillance Network (FoodNet) and compared outbreak illnesses with sporadic illnesses.

Available on the CDC’s website, key findings of IFSAC’s analysis include:

Campylobacter, Listeria monocytogenes, and E. coli O157 outbreak illnesses are not significantly different from sporadic illnesses with respect to patients’ illness severity, gender, and age.
Salmonella outbreak illnesses are not significantly different from sporadic illnesses with respect to illness severity and gender. For age, the percentages of outbreak and sporadic illnesses that occur among older children and adults are also similar. The percentage of outbreak illnesses in the youngest age category (0-3 years) was significantly lower compared to other age groups.

June 14, 2016

Retail Food Safety Forum

Navigating the Complexities of Common Foodborne Illnesses

By Dave Shumaker

2 Comments

Did you know there are more than 250 different types of foodborne illnesses? And while that number may seem daunting, especially when one in six Americans become ill from consuming contaminated foods or beverages each year, there are a few foodborne germs that are responsible for the majority of illness outbreaks, according to the CDC.¹ What are these illnesses? What are their symptoms? What can you do to help reduce the risk of an outbreak happening at your restaurant?

The CDC estimates that approximately 48 million people get sick from a foodborne illness each year, with 128,000 hospitalizations and 3,000 deaths. And of these numbers, there are two common illnesses that stand out—norovirus and Salmonella. In fact, these two pathogens account for nearly 70% of all foodborne illness outbreaks in the United States.

Norovirus

Norovirus is responsible for 58% of domestically acquired foodborne illnesses and nearly half of all foodborne disease outbreaks due to known agents.² Of these instances, most norovirus outbreaks occur in a food service setting, particularly restaurants.

Oftentimes, infected employees are the cause of these types of outbreaks. For example, individuals who are exhibiting symptoms come to work and contaminate food by touching either ready-to-eat foods or food-contact surfaces with their bare hands, which can lead to cross contamination.

Norovirus spreads easily and quickly, so people can contract it by not only by consuming contaminated foods or beverages, but also from having direct contact with individuals who are infected with the virus or touching surfaces or objects that have norovirus on them as well. In addition, norovirus outbreaks can also occur from foods that are contaminated at their source.²

In this video about Norovirus, I discuss the actions you can take, which includes practicing good hand hygiene, to reduce the risk of a norovirus outbreak negatively impacting your restaurant.

Salmonella

Each year in the United States, Salmonella is responsible for 1 million foodborne illnesses, 19,000 hospitalizations and 380 deaths.³ In fact, the pathogen accounts for 11% of all foodborne illnesses in the United States.

People become infected with Salmonella by either eating contaminated food that has not been properly cooked or has been contaminated after preparation.⁴ Salmonella is often found in raw food products that come from animals such as eggs, meat, and unpasteurized milk and dairy products.

While Salmonella is fairly common, measures can be taken to help reduce the risk of infection, such as through proper cooking and holding temperatures. In addition, proper disinfection and sanitization of food contact surfaces (i.e., countertops and cutting boards) helps reduce the risk of cross contamination. Practicing good hand hygiene before eating, and before and after preparing food can also help prevent the spread of this bacterium.

No one ever thinks their restaurant will fall victim to a foodborne illness outbreak, but it can happen and these outbreaks are more common than you may think. It is critical for you to share information about foodborne pathogens and prevention with your staff. This type of education and training can have a significant benefit to your restaurant.

References

Centers for Disease Control and Prevention. Foodborne Germs and Illnesses. Accessed May 8, 2016. Retrieved from http://www.cdc.gov/foodsafety/foodborne-germs.html
Centers for Disease Control and Prevention. Burden of Norovirus Illness and Outbreaks. Accessed May 8, 2016. Retrieved from http://www.cdc.gov/norovirus/php/illness-outbreaks.html
Centers for Disease Control and Prevention. Salmonella. Accessed May 17, 2016. Retrieved from http://www.cdc.gov/salmonella/
Vermont Department of Health. Salmonella. Accessed May 23, 2016. Retrieved from http://healthvermont.gov/prevent/salmonella/Salmonella.aspx

June 2, 2016

Deadly Outbreaks and the Role of Metagenomics

By Maria Fontanazza

No Comments

Americans consume 350 billion pounds of food each year, with one out of six people falling victim to foodborne illness, and 3000 dying. The significant amount of Listeria outbreaks hitting the industry (most recently, the staggering number occurring in produce) has left many food safety and quality assurance professionals searching for better methods of prevention and detection. Using big data, specifically metagenomics, to improve food safety and detect potentially deadly outbreaks is indeed where the future is headed.

DID YOU KNOW? The estimated U.S. cost of one case of Listeriosis is $1.4 million. Listeria is a prime concern due to the high percentage of fatalities that occur as a result of contracting Listeriosis. And what’s worse is the fact that many of the cases are preventable.

During Food Safety Tech’s Listeria Detection & Control Workshop this week, John Besser, Ph.D., deputy chief of CDC’s Enteric Diseases Laboratory Branch, outlined how the agency is leveraging metagenomics to find unrecognized problems in the food supply. Perhaps the most important element of disease surveillance is that it enables the detection of new issues, especially those whose presence was previously unknown.

Pathogen-specific surveillance allows the detection of more outbreaks, which will in turn make the food supply safer, because it will enable industry to understand the root causes of outbreaks and help them address problems much sooner. The CDC is focused on genome-based outbreak detection because of its ability to achieve faster detection—and with greater precision in identifying the source. The method has also helped the agency solve outbreaks with fewer cases occurring, and it concurrently helps rule out sources.

PulseNet, a nationwide database (comprised of 87 labs in the United States) that links cases most likely to share a cause for illness, has prompted food safety improvements across a variety of products, including sprouts, peanut products, leafy greens, flour, melons, eggs and poultry. Combine this capability with the Listeria initiative, which was launched in the mid-2000s, and the CDC has been able to find more (and smaller) outbreaks than ever before. In fact, there’s been a dramatic increase in the number of outbreak cases that have been solved (with the food source being identified). During the pre-whole genome sequencing (WGS) stage (September 2012–August 2013), only one outbreak was solved; in year one of the WGS project (September 2013–August 2014), four cases were solved; in year 2 of the WGS project (September 2014–August 2015), nine outbreaks were solved. In these respective time periods, the median number of cases per cluster dropped from six to four to three. In addition, the number of cases linked to a food source jumped from 6 to 16 to 93 during this respective time period.

Besser also discussed the role of metagenomics, or the study of total genetic material recovered directly from environmental samples. A couple of years ago, this was science fiction and wasn’t possible, he said. But as we look to the future, metagenomics will become a lot cheaper as computers become more powerful—and at break-neck speed. He referenced IBM Research, who earlier this year announced a project being conducted in conjunction with Mars, Inc. and Biorad for sequencing the food supply chain (calling it the “largest-ever metagenomics study”).

Read Food Safety Tech’s interview with IBM Research about the next-generation sequencing project, “Preventing Outbreaks a Matter of How, Not When”

Metagenomics enables the profiling of communities of microbiomes anywhere in the food supply chain. And the method is fast—it can potentially shave weeks off the process of identifying clusters of interest. In addition, it can increase the value of interviews conducted with patients who have fallen ill (Think about it: Do you remember what you ate two weeks ago? What about a month ago?).

Currently there are several limiting factors surrounding metagenomics: Cost; sequencing read length and error rate; specific software (and pipelines); computing processing power and bandwidth; and the signal-to-noise factor. However, with the rapid rate in which technology has been improving in this space, the high likelihood of these issues being addressed and resolved in the not-so-distant future will present exciting opportunities in outbreak prevention and detection.

May 27, 2016

FST Soapbox

Insurance and Food Safety: A Primer for the C-Suite

By Randy Fields

No Comments

Food safety risk is now a greater concern for retailers and manufacturers than ever before due to the combination of FSMA and increased consumer concerns. Supply chains are more complex, product recalls and foodborne illness outbreaks occur more frequently, and the new normal is prevention rather than inspection. Wrap that all up with advanced technology and the 24-hour news cycle, and consumers are acutely becoming aware of food safety issues as soon as they occur.

What this means for all of the participants in the global food supply chain is that you should review your insurance policies and look for gaps in coverage where you may be exposed. While no two recalls are the same, and foodborne illness outbreaks impact affected companies in different ways, certain trends have emerged to help better understand the claim friction points that frustrate companies after a food safety event.

Two of the most important tools to mitigate food safety risk are contaminated product insurance (CPI) and product recall insurance (PRI). Inventory, cost of refunds and recall expenses are three of the largest recall loss items suffered by companies. Combined, they are the largest percentage of loss (nearly 50%) and represent a substantial portion of uncovered loss for any insured under CPI/PRI. The sole basis for this frustrating friction point is simple—lack of traceability.

CPI/PRI only covers losses that result directly from a covered insured event. If a company is unable to support its claim that costs are directly related to the event and the resulting recall or outbreak, it will not be reimbursed under a CPI/PRI policy. And, as such, loss amounts are generally not covered under general liability and property policies either, so a significant portion of a company’s loss remains uncovered.

Here’s a recent claim example to illustrate the impact on a company that lacked the capability to properly trace its products. An insured purchased a CPI policy with a $2 million Accidental Contamination limit. An event occurred involving a contaminated food product, which triggered that coverage. During the review, the insured provided spreadsheets supporting nearly $1.1 million in customer credits for product shipped and either returned by the customer for disposal or destroyed by the customer. Unfortunately, based on a review of the information provided in support of the spreadsheets, the accountants found that the insured was unable to properly trace and support its claim that the returned or destroyed product was affected by the insured event recall. Under these circumstances, the accountants were only able to confirm $187,000 in losses. The result: The company was unable to recover nearly $1 million in potentially covered losses because it lacked traceability. These outcomes are not uncommon.

The insurance industry understands food safety risks and the need to evolve products to meet the needs of food industry clients. Companies can’t totally mitigate all food safety issues, but understanding the risks is the best way for a business to protect itself. Insurance industry leaders are working in partnership with their food sector clients to ensure that risks are better understood and that the client has appropriate systems in place to help mitigate them.

Insurance companies are tailoring their products to ensure that policies are developed to address the recall risks caused by regulatory changes and help companies ensure compliance as well as an understanding of the regulatory requirements. However, food companies may increasingly find coverage and limits adjusted lower for government recalls in high-risk environments. Insurers are also a key player in the promotion of food safety standards, and some offer favorable rates to food industry clients who are graded top tier for safety.

Some insurers go a step further, allowing clients to allocate a portion of their premium for pre-incident risk-analysis and crisis-response services. Top insurers provide clients access to a network of crisis management specialists as part of their food safety coverage. They should offer risk management guidance in areas such as food safety risk, regulatory compliance, supply chain management and product security.

One of the most critical risk mitigation tactics is developing long-term relationships with trusted, but verified, suppliers, distributors and other key partners. It is also important for companies to undertake regular site visits to their manufacturers or suppliers, and commission third-party audits to maintain reliability and transparency.

Not if, but when a product recall occurs, a company faces a myriad of risks. As with food safety, preventive planning can pay off significantly. By proactively working with insurers, trading partners and technology vendors you can reduce if not eliminate the negative impact of the event.

May 23, 2016

Supplier Accountability Focus of Latest Protest Against Chipotle

By Food Safety Tech Staff

No Comments

The labor union International Brotherhood of Teamsters has been holding nationwide protests at Chipotle locations this month, taking issue with one of the restaurant chain’s suppliers. The supplier at the focus of the demonstrations is California-based produce company Taylor Farms, which supplies tomatoes and peppers to Chipotle, according to Teamsters.

“Over the past five years, Taylor Farms has had more than 20 food recalls for problems such as Listeria, Salmonella and E. coli. In November 2015, Taylor Farms products containing celery and sold at Costco and other retail outlets were recalled for possible E. coli 0157:H7 contamination,” according to a Teamster news release. “At Taylor Farms’ plant in Tracy, Calif., the company has also committed safety and health violations and violations of laws that protect workers’ rights. Recently, the company settled extensive labor rights violations that involved payments of $267,000 to illegally terminated workers and a required posting in which the company promises to never again violate a long list of employee rights.”

The Teamsters protested at 12 Chipotle locations across the country, following 30 previous protests at Chipotle over the past several months.

Teamster Vice President Rome Aloise points the finger at Chipotle for allowing Taylor Farms to “have a total disregard for consumers’ and workers’ health and safety, as well as workers’ rights,” he said. “Chipotle claims to serve ‘Food With Integrity’, but where’s the integrity when it turns a blind eye to its supplier’s behavior? Chipotle must not cut and run – which would hurt Taylor Farms workers – it must carry out its social responsibility and demand Taylor Farms treat workers fairly and with respect.”

Taylor Farms has not released a statement addressing the protests.

April 11, 2016

Food Safety Attorney

The Criminal Offensive Begins

By Shawn K. Stevens

No Comments

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.

March 29, 2016

Food Safety Attorney

FDA’s Tactics to Reduce Outbreaks and Recalls

By Shawn K. Stevens

1 Comment

The advent of PulseNet in the late 1990s enabled more effective identification of outbreaks, even as many of them overlapped. The database brought to light the fact that many of the products sold in commerce nationwide contained ingredients that were at risk of contamination with dangerous pathogens. In many instances, these ingredients were in products from a single lot or batch and then sold by a single supplier to dozens of customers. From there, they were used in hundreds of products that would be distributed into thousands of retail locations.

Attend Food Safety Tech‘s Listeria Detection & Control Workshop | May 31–June 1 in St. Paul, MN | LEARN MOREFDA created the Reportable Food Registry (RFR) as a way to prevent the shipment of contaminated ingredients into the food supply. If received ingredients or products test positive for contaminants, the RFR requires that the company inform FDA. The agency uses the reports to take regulatory action against the original supplier and requires that all ingredients or products from all potentially affected lots be recalled from commerce. Because the RFR allows FDA to immediately begin tracking and containing ingredients testing positive for pathogens, its introduction in 2009 resulted in a significant spike in recalls.

Driven by the recalls triggered by PulseNet and the RFR, a national perception about an extremely unsafe U.S. food supply began to emerge. The public and media demanded that Congress take action, and so FSMA was born. The regulations require all FDA-regulated food companies to develop and implement written preventative control programs designed to control pathogens and other hazards in food. As a result, food companies will face heightened regulatory risk, scrutiny and exposure.

To further decrease the incidence of outbreaks and recalls, FDA is implementing regulatory enforcement initiatives that include sampling food products at retail for the presence of pathogens; conducting microbiological profiling of food processing facilities during routine inspections; and exploring criminal sanctions against companies that have been linked to positive samples in food products or production facilities associated with an outbreak or foodborne illness.

Microbiological Sampling in Retail

FDA is sampling products intended for human consumption as well as those for animal consumption. As testing continues at the retail level, the likelihood of more food products testing positive for the presence of pathogens is much higher. When positive product samples are found, FDA will take immediate action against the company that processed the product and require the company to recall all affected product. The agency will also demand access to the production facility at issue and conduct extensive environmental sampling, including from drains, floors, walls, production equipment, and finished products, in an effort to find the same strain as the sample testing positive at retail. If product or environmental samples test positive, FDA will perform genetic DNA testing on the isolates and compare the DNA fingerprints against those of the isolates collected from sick case patients in PulseNet over the past 15 years. If a match between the DNA fingerprint and an illness(es) in PulseNet is found, the agency will presume that these illnesses were caused by product originating from that particular facility. FDA will also demand access to all food production and microbiological testing records from previous months, or years, and critique those records.

Microbiological Sampling in Food Production Facilities

In accordance with FSMA, FDA will inspect all food production facilities (drains, floors, walls, food processing equipment, and finished products) that process high-risk ingredients or food products within the next three years (lower risk facilities will be inspected within the next five years). The agency is also performing extensive microbiological profiling of the food processing environment in all production facilities during routine inspections. If a positive sample is found, FDA may require the company to recall the affected product. It is expected that the level of sampling will intensity in the coming months and years as a result of FSMA mandates. And as the extensive microbiological sampling in food production facilities continues, FDA will perform genetic DNA testing on any positive samples collected, once again comparing the DNA fingerprints of samples against those of sick case patients over the last two decades. If a match is found, FDA will take the same course of action as in retail and presume all illnesses were caused by a food product originating from that specific facility. When that occurs, in addition to the potential recalls that may be required, the food companies at issue may become the target of a criminal investigation as well.

My next column will cite recent examples of FDA’s criminal offensive against food companies.

March 22, 2016

Out with the Old: From Dirty Rags to Cleaner, Safer Technology in Retail

By Maria Fontanazza

No Comments

Across the board, increased employee awareness and training has become a big issue in food safety. The foodborne illness outbreaks that hit Chipotle Mexican Grill has put retail and restaurant establishments on high alert, yet this is just another example of the reactive culture in which we operate, according to Matt Schiering, vice president and general manager at Sani Professional.

Matt Schiering, Sani Professional — “Think about your own restaurant experiences. Guests don’t want to see or be confronted with a greyish brown rag [that is used to] wipe a table, then wipe a seat, then wipe an adjacent table. It just screams unclean,” says Matt Schiering of Sani Professional.

Food Safety Tech recently hit the road with Schiering and John Caton, regional sales manager at Sani Professional, to experience first hand how one company is communicating its message to customers. Breaking with tradition has been an important part of promoting cleaner technology: The use of the rag and bucket as a means to clean both the front of the house (tables, chairs, counters, etc.) as well as the back of restaurants and retail establishments, while still fairly common, has outlived its effectiveness, and frankly, says Schiering, “screams unclean”. Caton and Schiering continued the conversation with their customers about how using disposable wipes for cleaning, sanitizing and disinfection helps prevent the spread of contamination, along with the cost savings associated with using such products. The company takes a multi-prong approach to promoting awareness among its current and potential clients, from deploying a sales force that directly interacts with quality assurance and food safety professionals in establishments to offering how advances in sustainable technology can help them stay ahead of the curve to driving consumer advocacy.

Food Safety Tech: How is Sani Professional raising the level awareness of the disadvantages of the traditional cleaning method (the rag and bucket method) in the retail environment?

Matt Schiering: There are a few ways to raise the level of awareness. The first and foremost is “feet on the street”. We’ve deliberately moved toward a direct-to-customer sales force, which gives us the opportunity to interface directly with QA, food safety and operations to show them a simpler, more efficient, more effective, and guest appealing way versus the traditional rag and bucket. The first win is one for the user (the employees of a given establishment), because associates have shown us time and time again that they do not like the mixing and measuring, and the errors that are often associated with that process. They don’t like the dirty rag itself—having to fish it out of the bowl and then present it or be seen with it in the front of the establishment. It’s a win for the operator (the manager), because with our system, there’s no longer any heightened heart rate when the health inspector shows up. One of the most common violations is the water in the buckets being out of spec or the rags themselves not being inside the bucket per regulation. And perhaps most importantly, it’s a win for the guest. Think about your own restaurant experiences. Guests don’t want to see or be confronted with a greyish brown rag [that is used to] wipe a table, then wipe a seat, then wipe an adjacent table. It just screams unclean.

As we talk about the evolution in perception, away from traditional methods, we believe that speaking directly to the consumer has to play a role. There has to be a degree of consumer-driven advocacy for a better way. – Matt Schiering

FST: Regarding employee training, how should retailers be more proactive in ensuring their employees are engaging in proper food safety practices and aren’t spreading foodborne illnesses?

Schiering: It varies by chain. Unfortunately, we live in a reactive culture—and that goes well beyond the restaurant industry.

Oftentimes a problem precedes a protocol or other means of addressing said problem. Chipotle is one example: They’ve taken an exhaustive look at restructuring their food safety protocols as a result of a myriad of foodborne illness-related issues that they suffered in the preceding months. The [retailers] who are doing it best are the ones who build it into their establishment in the first place where it’s not predicated by some sort of problem. That involves training materials, in-service lessons, and online training (i.e., ServSafe certifications). Waffle House, for example, has Waffle House University where food safety is a key component to that system.

We envision ourselves as part of that process. We take a microcosm—the notion of proper food handling, prevention of cross contamination related foodborne illness—and provide an innovative and easy-to-use solution, and all the training and collateral materials associated with the solution that explain the proper use. We also provide test kits so that if the health inspector wants an in-the-moment proof that our product is doing what the label says it does, [the retailer] can provide that at a moments notice. It becomes more of a service proposition than simply a product-driven solution.

FST: Where do you see sustainable products fitting into the space?

Schiering: This also boils down to education, because the perception of disposables is that they’re wasteful, when in fact they needn’t be any more costly than existing solutions.

If you’re using a linen service, there’s a cost associated with renting towels, but there’s a higher cost associated with wasting towels. So if a towel ends up in a gym bag or in the trash because of overuse and/or abuse, there’s a significant upcharge for not returning that towel to the rental agency. That’s what we call the hidden cost or the dirty little secret of rag and bucket sanitizing. When you factor that in, and everyone [retailers] experiences that type of loss, and you look at the fact that sanitizing wipes kill pathogens trapped in the wipe as well as whatever it is coming into contact with at the surface, thereby enabling it to be used on multiple surfaces without causing cross contamination—the cost aligns very closely. And of course it’s a more value-added guest experience than a dirty rag being used from table to table, which is not preventing cross contamination.

Speaking to the environmental piece: At the moment, we’re actually fairly well ahead of the industry. It varies chain to chain—some chains are doing a better job than others, because it’s part of their corporate culture. But by providing solutions that are leveraging either recyclable substrates or compostable substrates, we provide greater opportunity to reduce the environmental impact often associated with disposable products. If a retailer is working with a waste management partner that can handle industrial compostable products or non-solid state recyclables, we have solutions that are appropriate for those operations, so that we’re not just adding to landfills but rather essentially recycling and/or regenerating the products that are being used, and at no greater cost.

Most retailers haven’t gotten there yet. It speaks directly to corporate culture and corporate mission of the end user. We deliberately target customers who are a little bit ahead of the curve when it comes to “green technology or “green behavior”. And so when the rest of the industry catches up, we’re more than ready to serve them with products that meet those needs.

FST: Where do consumers fit into the picture, especially has industry moves away from traditional methods in food safety?

Schiering: About a decade ago, consumers started demanding that retailers like Walmart, Target, and local grocers provide a means of sanitizing shopping carts when they walk into their local retail establishments. There were myriad news reports about the germs and potential for contamination and illness arising from the often used and rarely cleaned implements—these vehicles for placing your groceries. We answered the call a decade ago, and at one time it was a significant piece of our business. It continues to be a marketplace we serve, albeit a much commoditized one. But the rise in that solution would not have taken place if not for consumers advocating for a better way.

We’re starting to create a presence on Facebook and other social media outlets to remind consumers that it’s up to them in many cases to ask for, if not demand a more effective, more pleasing way of ensuring their safety in dining establishments. Unfortunately, incidents like what we saw at the large Mexican food service retailer do ultimately play a part in that consumer advocacy, albeit a negative one, because we are a reactive society. But by presenting a positive message and sharing alternatives in the absence of citing examples or shaming retailers through the problem, we believe that will be one of the keys to changing perceptions at the retail level.

Norovirus

Salmonella

References

Multiple Non-public Cases

Microbiological Sampling in Retail

Microbiological Sampling in Food Production Facilities

How We Use Cookies