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.
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.
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
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.
The following infographic outlines the state of foodborne disease in the United States and current entities/legislation that are working to prevent illness.
How LIMS (laboratory information management systems) can help with documenting environmental monitoring
The full infographic from Autoscribe Informatics is available on the company’s website.
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.
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.”
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 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.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.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.
Anyone who has attended a food safety conference in the last few years has experienced some type of whole genome sequencing (WGS) presentation. WGS is the next big thing for food safety. The technology has been adopted by regulatory agencies, academics, and some food companies. A lot has been said, but there are still some questions regarding the implementation and ramifications of WGS in the food processing environment.
There are a few key acronyms to understand the aspects of genomics in food safety (See Table I below).
PFGE
Pulse Field Gel Electrophoresis
Technique using restriction enzymes and DNA fragment separation via an electronic field for creation of a bacterial isolate DNA fingerprint; PFGE is being replaced by WGS at CDC and other public health laboratories
WGS
Whole Genome Sequencing
The general term used for sequencing—a misnomer—the entirety of the genome is not used, and depends on the analytical methodology implemented
NGS
Next Generation Sequencing
NGS is the next set of technology to do WGS and other genomic applications
SNP
Single Nucleotide Polymorphisms
A variation in a single nucleotide that occurs in specific position of an organism’s genome; Used in WGS as a methodology for determining genetic sameness between organisms
MLST
Multilocus sequence typing
A methodology for determining genetic sameness between organisms; Compares internal fragment DNA sequences from multiple housekeeping genes
16S
16s RNA sequencing
A highly conserved region of the bacterial genome used for species and strain identification
Joseph Heinzelmann will be presenting: Listeria Testing Platforms: Old School Technology vs New Innovative Technology during the 2016 Food Safety Consortium | LEARN MOREIn 1996, the CDC established the PulseNet program for investigating potential foodborne illness outbreaks. PulseNet has relied on using bacterial DNA fingerprints generated via PFGE as comparisons for mapping potential sources and spread of the outbreaks. Due to a number of advantages over PFGE, WGS is quickly becoming the preferred method for organism identification and comparison. Moving to WGS has two critical improvements over PFGE: accuracy and relatedness interpretation. Like PFGE there are nuances when defining the difference between two very closely related organisms. However, instead of defining restriction enzymes and comparing the number of bands, the language changes to either single nucleotide polymorphisms (SNP) or the number of alleles. The other important aspect WGS improves is the ability to determine and interpret the relatedness of organisms more broadly. The frequent Listeria outbreaks and incidence from 1983-2015 provide an insight to what the future might hold with WGS implementation.1 The incidence report shows the increased ability to quickly and more accurately define relatedness between clinical cases creates a link of potential cases much faster.
WGS also provides key practical changes for outbreaks and recalls in the food industry. Sequencing provides a much faster response time and therefore means the outbreaks of foodborne illness decrease, as does the number of cases in each outbreak. As the resolution of the outbreaks increases, the number of outbreaks identified increases. The actual number of outbreaks has likely not increased, but the reported number of outbreaks will increase due increased resolution of the analytical method.
Figure 1: (Permission for use of slide from Patricia M. Griffin, M.D. – Center for Disease Control and Prevention)
WGS continues to establish itself as the go-to technology for the food safety agencies. For example, the USDA food safety inspection service recently published the FY2017–2021 goals. The first bullet point under modernizing inspection systems, policies and the use of scientific approaches is the implementation of in-field screening and whole genome sequencing for outbreak expediency.
Agencies and Adoption
The success of FDA and CDC Listeria project provides a foundation for implementation of WGS for outbreak investigations. The three agencies adopting WGS for outbreak investigations and as replacement for PulseNet are the CDC, FDA and USDA. However, there are still questions on the part of the FDA for when WGS is utilized, including under what circumstances and instances the data will be used.
In recent public forums, the FDA has acknowledged that there are situations when a recall would be a potential solution based on WGS results in the absence of any clinical cases.2 One critical question that still exists in spite of the public presentations and published articles is a clear definitions of when WGS surveillance data will be used for recall purposes, and what type of supporting documentation a facility would need to provide to prove that it had adequate controls in place.
A key element is the definition between agencies for sameness or genetic distance. The FDA and FSIS are using a SNP approach. A sequence is generated from a bacterial isolate, then compared with a known clinical case, or a suspected strain, and the number of different SNPs determines if the strains are identical. The CDC is using the Multilocus sequence typing (MLST) approach.
Simple sequence comparisons are unfortunately not alone sufficient for sameness determination, as various metabolic, taxa specific and environmental parameters must also be considered. Stressful environments and growth rates have significant impact on how quickly SNPs can occur. The three primary pathogens being examined by WGS have very different genetic makeups. Listeria monocytogenes has a relatively conserved genomic taxa, typically associated with cooler environments, and is gram positive. Listeria monocytogenes has a doubling time of 45–60 minutes under enrichment conditions.3 These are contrasted with E. coli O157:H7, a gram negative bacteria, associated with higher growth rates and higher horizontal gene transfer mechanisms. For example, in an examination of E. coli O104, and in research conducted by the University in Madurai, it showed 38 horizontal gene elements.4
These two contrasting examples demonstrate the complexity of the genetic distance question. It demonstrates a need for specific definitions for sameness within a microbiological taxa, and with potential qualifiers based on the environment and potential genetic event triggers. The definitions around SNPs and alleles that define how closely related a Listeriamonocytogenes in a cold facility should be vastly different from an E. coli from a warm environment, under more suitable growth conditions. Another element of interest, but largely unexplored is convergent evolution. In a given environment, with similar conditions, what is the probability of two different organisms converging on a nearly identical genome, and how long would it take?
MLST vs. SNP
As previously stated, the three agencies have chosen different approaches for the analytical methodology: MLST for CDC and SNP of the FDA and USDA. For clarity, both analytical approaches have demonstrated superiority over the incumbent PFGE mythology. MLST does rely on an existing database for allele comparison. A SNP based approach is supported by a database, but is often used in defining genetic distance specifically between two isolates. Both approaches can help build phylogenetic trees.
There are tradeoffs with both approaches. There is a higher requirement for processing and bioinformatics capabilities when using a SNP based approach. However, the resolution between organisms and large groups of organisms is meaningful using SNP comparison. The key take away is MLST uses a gene-to-gene comparison, and the SNP approach is gene agnostic. As mentioned in Table 1, both approaches do not use every A, T, C, and G in the analytical comparisons. Whole genome sequencing in this context is a misnomer, because not every gene is used in either analysis.
Commercial Applications
Utilizing WGS for companies as a preventive measure is still being developed. GenomeTrakr has been established as the data repository for sequenced isolates from the FDA, USDA, CDC and public health labs. The data is housed at the National Center for Biotechnology Information (NCBI). The database contains more than 71,000 isolates and has been used in surveillance and outbreak investigations. There is a current gap between on premise bioinformatics and using GenomeTrakr.
The FDA has stated there are examples where isolates found in a processing facility would help support a recall in the absence of epidemiological evidence, and companies are waiting on clarification before adopting GenomeTrakr as a routine analysis tool. However, services like NeoSeek, a genomic test service by Neogen Corp. are an alternative to public gene databases like GenomeTrakr. In addition to trouble shooting events with WGS, NeoSeek provides services such as spoilage microorganism ID and source tracking, pathogen point source tracking. Using next generation sequencing, a private database, and applications such as 16s metagenomic analysis, phylogenetic tree generation, and identification programs with NeoSeek, companies can answer critical food safety and food quality questions.
CDC’s Robert Tauxe will be honored by STOP Foodborne Illness at a fundraiser during the 2016 Food Safety Consortium.
STOP Foodborne Illness is honored again this year to be given the opportunity by Food Safety Tech to hold a fundraising event at the Food Safety Consortium on Tuesday, December 6 at 7 p.m. in Schaumburg, Illinois (Chicago area). We are honoring 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 with the Advancing Science for Food Safety Award; Scott Horsfall, representing The California Leafy Green Marketing Association with the Food Safety Training Award; and Jeff Almer, whose mother died from foodborne illness for the Food Safety Hero award. We will have a silent auction, music and food. This is a time to pause and thank those who have positively influenced our food safety system and we hope you will join us.
STOP Foodborne Illness is a national nonprofit public health organization dedicated to the prevention of illness and death from foodborne pathogens.
Advocating for sound public policy
Building public awareness
Assisting those impacted by foodborne illness
Scott Horsfall
Dan Sutton
Jeff Almer
Last year’s Food Safety Heroes were Nancy Donley, former spokesperson for Safe Tables Our Priority and STOP Foodborne Illness and Frank Yiannas, vice president of food safety at Walmart.
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.
At the 2016 Food Safety Consortium, STOP Foodborne Illness will have a fundraiser to honor heroes in food safety. |December 6, 2016, 7–9 pm | LEARN MOREIn 2012 STOP Foodborne Illness established a relationship, which evolved into a partnership, with the California Leafy Green Marketing Agreement (LGMA) organization. On my first visit to LGMA, I met key staff members and observed a mock audit. We had good initial conversations. Scott Horsfall, CEO of LGMA, and I continued to talk and a second visit ensued, this time with individuals who had been ill with E-Coli from Leafy Greens. Everyone was a bit nervous, but it was a productive and even healing experience. We visited farms and processing plants, heard from farmers and shared a lovely meal outdoors with the farmers. On the last day, we sat in a room with tables configured in a large square and each person took turns introducing themselves, talking about why they were at the table, what roles they had in the leafy green business, and the visitors shared personal heart wrenching stories of illness and death from foodborne illness. There was not a dry eye in the room during and after this encounter. Every farmer vowed to do everything possible to prevent pathogens from making their way into the market place. This was a profound experience for everyone involved.
The following year, Scott proposed that STOP Foodborne Illness and LGMA jointly create a video for training purposes. That project came to life in the summer of 2014. It is a video and a project that LGMA and STOP Foodborne Illness professionals are deeply proud of and love to share with others (the video comes in several versions and is available in Spanish). Scott and I continue to speak about the partnership and look for additional ways to collaborate.
Food safety is about collaboration and finding solutions and preventing illness and death from foodborne pathogens. This week I spoke with a mother whose daughter died a year ago from foodborne illness (not from produce). I told her that I so badly wish that we could have prevented her beautiful daughter’s death and vowed to continue this important work. We are not there yet: Each of us must be completely committed to getting to a place where we don’t hear these stories. And we will get there by keeping the “why” at the forefront and continuing to develop critical strategies that reduce and work to eliminate the problem. Thank you to all who are dedicated to creating and sustaining a safe food supply and a special thanks to LGMA. You can see the LGMA video, “Video: The Why Behind Food Safety”, on our homepage.
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