Just when we thought the E.coli O157:H7 outbreak involving romaine lettuce was over: Today CDC issued a Food Safety Alert informing consumers not to eat ANY romaine lettuce. Retailers and restaurants shouldn’t serve any either.
“Thirty-two people infected with the outbreak strain of Shiga toxin-producing E. coli O157:H7 have been reported from 11 states.
Illnesses started on dates ranging from October 8, 2018 to October 31, 2018.
Thirteen people were hospitalized, including one person who developed hemolytic uremic syndrome, a type of kidney failure. No deaths have been reported.” – CDC
The agency is urging against the consumption of romaine lettuce because they haven’t been able to identify a common grower, supplier, distributor or brand.
Could we be in for another widespread outbreak? Just last week during a panel discussion at the Food Safety Consortium, the FDA and CDC said that when the last outbreak occurred they knew it would get bad really quickly.
This year’s multistate outbreak of E.coli O157:H7 infections linked to romaine lettuce affected 210 people, killing five. Although the outbreak was officially declared over by the end of June, questions still remain as to the exact source. Given the widespread nature of the outbreak and the speed with which illnesses occurred, there are many lessons to be learned from the case.
During last week’s annual Food Safety Consortium, industry stakeholders from the FDA, CDC and produce associations gathered to discuss agency action upon learning of the outbreak and where there is room for improvement.
The investigation began in April 2018 when the New Jersey Department of Health contacted the CDC about a cluster of E.coli O157:H7 illnesses from people who said they ate salads at various locations of the same restaurant chain. Three days later, the agency was able to confirm eight O157 isolates from six states with the same patterns using PulseNet. And five days after that, the CDC posted a notice on its website about the investigation of 17 cases across seven states.
“We knew right away that this was going to get bad and that it would get bad quickly,” said Matthew Wise, deputy branch chief for outbreak response at the Outbreak Response and Prevention Branch of the CDC. “We saw illnesses ramp up quickly.” He added that the agency saw a lot of illness subclusters, all with romaine lettuce as the common ingredient.
The epidemiological evidence clearly indicated chopped romaine lettuce, and it appeared that all the affected romaine was coming from the Yuma, Arizona growing region, noted Stic Harris, director of the Coordinated Outbreak Response & Evaluation Network at FDA. But then things got even more confusing, as an Alaskan correctional facility was also investigating a cluster of cases. This allowed the agency to trace the source directly back to Harrison Farms as the sole supplier to the correctional facility. However, as the multi-agency investigation continued, they uncovered that the source was not just one farm. “There were three dozen farms in the Yuma region that supplied romaine lettuce,” said Harris, adding that we may never know which exact farm, and even if it was one farm, that was the source of the outbreak.
During June, July and August, the FDA sent a multidisciplinary team of 16-18 people to conduct an environmental assessment of the affected area. Upon taking 111 samples, they found 13 different Shiga toxin-producing E. coli strains, but only three matched the strain of the outbreak. Water from 14 locations, including discharge, reservoir and canal water, was also tested. The environmental assessment found pervasive contamination in the water. But here was the big problem, said Harris: “There was no smoking gun. We don’t know how the E.coli got into the water, and we don’t know how the water got onto the lettuce.” He added that additional research is needed, and that government and non-government work must continue to identify the source.
There are several challenges associated with the complexity of this type of produce outbreak, said Harris and Wise:
The production lot information disappears at the point of service
Having a commingled product hinders traceback
Records present a challenge because agencies try to look at each company and their individual records, and every company has their own way of doing things—this takes time
The breadth of the impacted area—trying to do an environmental assessment for that area was staggering work
People who eat lettuce eat it often
Many people don’t remember what type of lettuce they ate
The product has a short shelf life
Communication: The packaging isn’t transparent on where it’s grown
Scott Horsfall, CEO, California Leafy Green Products Handler Marketing Agreement, chimed in on the challenges posed by the complexity of the outbreak. “If you compare these numbers with the 2016 spinach outbreak…they’re very similar [in the] total number of illnesses [and] number of states involved. But in [the spinach outbreak], it led to a specific farm. What we saw this time was very different.”
When it comes to food safety compliance, learning lessons the hard way is never a good practice. Violations, non-compliance and documentation mishaps put a major damper on your business. From delays in production to the dreaded recall, these mistakes can cost thousands, if not millions, of dollars. Don’t learn these lessons the hard way. See our Case Studies and learn how companies are avoiding these costly mistakes with TraceGains.
One of the large successes in dealing with the outbreak is that the agencies issued public warnings quickly, said Wise. The produce industry also came together to form the Leafy Greens Food Safety Task Force. In addition, FDA is expanding its sampling for the coming harvests, according to Harris. “I think that in terms of the speed of the environmental assessment, we need to be quicker with that. We apparently hadn’t done one in quite a long time at FDA,” he said.
Harris and Wise also stressed that for industry to work more effectively together, they need to work with the FDA and CDC before there is an outbreak.
“This outbreak was a frustrating experience for all of us,” said Horsfall. “We have to communicate more and better when we can. And as an industry, stop these outbreaks from happening.”
Just in time for Thanksgiving, consumers are worrying about whether the turkey they are buying for the holiday is contaminated with Salmonella. A multistate outbreak of drug-resistant Salmonella linked to raw turkey products has been going on for months, but now USDA is facing increasing pressure to name any associated turkey brands. According to the CDC, “a single, common supplier of raw turkey products or of live turkeys has not been identified.”
As of the agency’s last update (November 5), 164 people across 35 states have been infected with the outbreak stream of Salmonella Reading. 63 people have been hospitalized, and one death has been reported. Three people reported living in households where raw turkey pet food was given to pets.
Thus far the CDC isn’t advising retailers to stop sell raw turkey. It is stresses that consumers should follow the basic food safety steps to prevent Salmonella infections, including proper handwashing, cooking the turkey to the proper temperature (including reheating the meat), keeping food prep areas clean, proper thawing of turkey in the refrigerator and avoiding feeding pets raw food.
CDC states that if the information becomes available, it will provide notification related to the supplier(s) related to the outbreak.
“It’s been quite a year for outbreaks,” said John Besser, Ph.D., deputy chief, enteric diseases laboratory branch, at CDC, referring to the pathogens that have plagued a variety of consumer products in 2018. “Out of this group, there are a lot of the things you’d expect, but also some brand new unexpected [products affected] like shredded coconut and Honey Smacks cereal.”
Despite the number of outbreaks that have hit the food industry in 2018, “this is a really exciting time to be in public health and food safety, because there are a lot of tools we can use to help make food safer,” said Besser. Most of the diseases that impact the food industry are preventable if their source can be identified, and using big data can have a tremendous impact on improving food safety.
Yesterday John Besser informed attendees at the 2018 Food Safety Consortium about CDC’s latest efforts in foodborne disease surveillance, which he defines as the
systematic collection, analysis and interpretation of health data. The agency is actively working to identify unrecognized gaps in the food supply chain and provide the industry with information it can use to make products safer. “The most important reason for detecting outbreaks is so we can identify the problem and fix it,” said Besser.
There are two ways that CDC detects outbreaks. The first is via the “citizen reporters” who are observant and alert the agency. (This is actually how E.coli O157 was discovered). The second is through pathogen-specific surveillance where CDC takes lab information and links cases that are geographically diverse. These cases are often widely dispersed and are the most effective way to find food production and distribution problems, and are often easier to address than local issues, according to Besser.
He went on to review the successes of PulseNet and the promise of whole genome sequencing (WGS) and metagenomics. The CDC’s PulseNet nationwide WGS implementation project is underway and will result in a “tsunami of data”, with the timeline as follows:
January 15, 2018: Listeria monocytogenes
October 15, 2018: Campylobacter jejuni/coli
January 15, 2019: Diarrheagenic E.coli (including STEC)
March 15, 2019: Salmonella enterica
Metagenomics will continue to play a large role in enabling unbiased sequencing of all nucleic acids in an environment. It will help to directly characterize sequences from samples, food and people (i.e., the gut), and could aid in pathogen discovery.
“I think within just a few years, it’s going to be the standard for tests,” said Besser. “My prediction is that you’ll be able to do this test in the production environment.”
RizePoint, a leading provider of brand, quality, and safety management software (QMS), will be exhibiting at Food Safety Consortium (FSC) in Chicago from November 13–15, 2018.
FSC is the first event where the company is demonstrating the new functionality for frictionless supplier onboarding and upgraded supplier quality management (SQM). This product enhancement helps managers in any industry onboard, track, and communicate with suppliers and vendors to help ensure regulatory and company standards compliance. Demonstrations will take place in booth 121 during exhibition hours.
“This expanded supplier quality solution further demonstrates RizePoint’s commitment to foster brand protection. We have enhanced the supplier onboarding experience, improved communication with suppliers, and made tracking compliance documents simple and easy.” – Frank Maylett, RizePoint
The update to the RizePoint enterprise compliance SaaS solution also includes:
Creating clear and simple onboarding workflows
Configuring forms and surveys based on your specific business needs
Building reports and dashboards that help you see into the health of supplier compliance
Setting due dates with automated alerts for expiring qualifying documents
Automating CAPA with triggered alerts and communications
RizePoint offers a robust software solution that helps companies keep brand promises through their quality and compliance efforts. Our customers gather better data, see necessary actions earlier, and act faster to correct issues before they become costly liabilities. Considered the industry standard for food service, hospitality, and retail, RizePoint mobile and cloud-based solutions serve millions of audits every year. RizePoint is headquartered in Salt Lake City, Utah. For more information, visit RizePoint.com.
About Food Safety Consortium
The Food Safety Consortium is a premier educational and networking event for food safety solutions. Attracting the most influential minds in Food Safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore five diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. Learn more about FSC at http://foodsafetyconsortium.net/.
Yesterday FDA released the initial phase of its findings of a 10-year nationwide study that looks at the relationship between food safety management systems, certified food protection managers, and the occurrence of risk factors and food safety behaviors/practices, and how this contributes to foodborne illness outbreaks in retail establishments. This first phase collected data from 2013–2014; subsequent data collection will be from 2017 and 2021. The entire span of the study is 2013–2023.
Restaurants had the most effective control over ensuring there is no bare hand contact with RTE foods as well as cooking raw animal foods (including meat, poultry and eggs) to the required temperature
Unsafe food behaviors in fast food and full-service restaurants. Improvement needed in:
Employee hand washing (knowing when and how to do it)
Proper temperature control of foods that require refrigeration to limit pathogen growth
Study results will be used to help advise retail food safety initiative and policies, industry partnerships and specific intervention strategies that target foodborne illness risk factors. It will also aid in providing technical assistance to state, local and other regulatory professionals. FDA put together a factsheet with highlights of the study.
“FDA and the CDC informed Conagra Brands that a sample of Duncan Hines Classic White Cake Mix that contained Salmonella Agbeni matched the Salmonella collected from ill persons reported to the CDC. This was determined through Whole Genome Sequencing, a type of DNA analysis. The sample was collected by Oregon health officials. Based on this information, Conagra Brands is working with FDA to proactively conduct a voluntary recall of Duncan Hines cake mixes from the market. The FDA is conducting an inspection at the Conagra Brands-owned manufacturing facility that produced the cake mixes. The FDA is also collecting environmental and product samples.” – FDA, November 7, 2018
After a retail sample tested positive for Salmonella, Duncan Hines issued a recall of four varieties of its cake mixes. The sample that tested positive for the pathogen was the Classic White cake mix, but out of an “abundance of caution”, the company recalled its Classic Butter Golden, Signature Confetti and Classic Yellow cake mixes that were manufactured during the same period of time.
“Several of the individuals reported consuming a cake mix at some point prior to becoming ill, and some may have also consumed these products raw and not baked. Consumers are reminded not to consume any raw batter. Cake mixes and batter can be made with ingredients such as eggs or flour which can carry risks of bacteria that are rendered harmless by baking, frying or boiling.” – Conagra Brands
The recalled products have a “Best If Used By Date” ranging from March 7 to March 13, 2019 and were distributed to U.S. retailers as well as exported internationally (on a limited basis). Consumers are advised to return the recalled products to the store in which they were purchased.
Yesterday FDA released the final guidance on its mandatory recall authority under FSMA. Although the agency has only taken a mandatory recall action once since 2011—in April, FDA issued a recall of Triangle Pharmanaturals Kratom Products—the FDA’s authority to recall products “plays an important role in ensuring that potentially dangerous food products are removed from the marketplace,” states the agency in a release. “The agency remains committed to working with firms to facilitate the orderly and prompt voluntary removal of potentially dangerous products from the food supply. FDA Recall Coordinators are available to assist firms during the recall process.”
FDA Commissioner Scott Gottlieb, M.D. also released a statement about the agency’s commitment to keeping unsafe products off the market. “When issues arise that would put consumers at risk, we won’t hesitate to mandate the removal of a product from the market using the full extent of our authorities. It’s our responsibility. And it’s critical to our mission to ensure the safety of Americans,” stated Gottlieb in a press release. He added that most companies are cooperative in closely working with FDA to initiate voluntary recalls.
FDA will be making additional moves to enhance its recall policies, according to Gottlieb.
This week CERTUS announced that it achieved AOAC Performance Tested certification for its rapid pathogen detection platform, the CERTUS System. The system uses SERS nanoparticle technology and real-time detection to provide users with faster results versus sending the samples to a third-party via mail.
AOAC validation gives small-to-mid size processing facilities an assurance on the reliability and efficiency of CERTUS’s in-house environmental Listeria monitoring process, according to CERTUS.. The company’s system has been certified for use on stainless steel, concrete, plastic and ceramic surfaces. The CERTUS system provides 98% accuracy by targeting organisms without destroying them and reducing the effect of substances commonly found in environmental food samples on assay results.
“We’re extremely proud and put tremendous value on achieving AOAC certification within two years of beginning our journey to help protect food production beyond a shadow of a doubt,” said CERTUS President John Coomes in a press release. “Recognition by AOAC, coupled with our robust R&D team and strong financial backing, demonstrates that we are moving quickly to bring unmatched, precise solutions to food processors across the industry.”
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