ADM Milling Co. announced that it is expanding a current recall to include all five-pound bags of Baker’s Corner All Purpose Flour that is packaged for ALDI due to possible presence of E. coli. The issue was uncovered when the Rhode Island Department of Health conducted testing of the product.
The particular strain of E. coli has been connected to 17 illnesses in eight states, but the recall affects flour that was distributed in ALDI stores in 11 states (Connecticut, Delaware, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont and West Virginia.
The previous recall only affected two lots of the five-pound bags of flour. ADM Milling is advising consumers against consuming flour that has not been thoroughly cooked.
The report states that a sediment sample coming from an on-farm water reservoir in Santa Maria (Santa Barbara County, California) tested positive for the outbreak strain of E. coli O157:H7. Although this particular farm was identified in several legs of the Fall 2018 traceback investigations that occurred in the United States and Canada, as well as being a possible supplier of romaine lettuce in the 2017 traceback investigations, the FDA said that the farm is not the single source of the outbreak, as there is “insufficient evidence”. The traceback suggests that the contaminated lettuce could have come from several farms, because not all tracebacks led to the farm on which the contaminated sediment was found.
“The finding of the outbreak strain in the sediment of the water reservoir is significant, as studies have shown that generic E. coli can survive in sediments much longer than in the overlying water. It’s possible that the outbreak strain may have been present in the on-farm water reservoir for some months or even years before the investigation team collected the positive sample. It is also possible that the outbreak strain may have been repeatedly introduced into the reservoir from an unknown source,” stated FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas in a press announcement.
Although the exact route of contamination cannot be confirmed, the FDA hypothesizes that it could have occurred through the use of agricultural water from an open reservoir, which has increased potential for contamination.
The investigation teams also found evidence of “extensive” wild animal activity and animal burrows near the contaminated reservoir, as well as adjacent land use for animal grazing, all of which could have contributed to the contamination.
Considering the significant effect that the past two E.coli outbreaks involving romaine lettuce have had on both the public as well as the produce industry, FDA made several recommendations on preventive measures that leafy greens growers and industry can take to avoid such pathogenic contamination, including:
Assessing growing operations to ensure they are in line with compliance to FSMA and good agricultural practices
Making sure that any agricultural water that comes into direct contact with the harvestable portion of the crop, food contact surfaces and harvest equipment is safe and sanitary
Address and mitigate risks associated with agricultural water contamination that can occur as a result of intrusion by wild animals
Address and mitigate risks associated with the use of land near or adjacent to agricultural water sources that can lead to contamination
Conduct root cause analysis whenever a foodborne pathogen is identified in the growing environment, agricultural inputs like water or soil, raw agricultural commodities, or “fresh-cut” ready-to-eat produce
For the broader industry:
The development of real-time procedures that enable rapid examination of the potential scope, source and route of contamination
All leafy green products should have the ability to be traced back to the source in real time, and information include harvest date. In November, FDA requested voluntary labeling [https://foodsafetytech.com/news_article/cdc-alert-do-not-eat-romaine-lettuce-throw-it-out/] to help consumers identify products affected during an outbreak
The adoption of best practices in supply chain traceability
Various polymers are used in food contact applications that include food packaging and disposable gloves. More than 30 different types are used in packaging and up to six in disposables gloves. In terms of safeguards for the U.S. food supply as well as user safety, it is worth noting that 87% of the production of packaging polymers is based in the United States and subject to FDA regulation and monitoring. On the other hand, all (100%) of the 100 or more glove factories supplying the United States are based in Southeast Asia, according to a report by the British Medical Association and are not subjected to the same FDA monitoring or scrutiny.1
Packaging production is carefully overseen by the FDA, is included in FSMA, and covered in the HACCP process. Toxicology of food packaging is carefully prescribed and subject to strict enforcement action from production to storage.
Glove factories, however, are generally self-regulated, with FDA compliance required for a rough outline of the ingredients of the gloves rather than the final product. Few controls are required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance. A clear opportunity exists for accidental contamination within the glove-making process. More significantly, because of the geographic and economic implications in workforce and workplace conditions, intentional contamination potential is greatly increased. Polymer gloves utilized in food processing and service have been implicated in 15–18% of foodborne illness outbreaks in the United States.2
There is a striking difference in the requirements for these two different types of food contact polymers. Food packaging is extensively regulated, gets tested within the context of completed food product and has production primarily in the United States under close supervision. Disposable gloves, on the other hand, rely on self certification, often with testing results only on glove constituents, and little or no oversight of factory process and conditions. It seems as though this is a glaringly obvious but little accounted for risk to the U.S. food sector.
As a result, based on the root cause analysis of food cross contamination, a selection of tests and certifications, some of which are unique to the glove industry, are being implemented by one particular glove supplier. These tests ensure that their gloves coming into the United States are made in clean, well-run factories, free of any type of contamination and are consistent in material makeup to original food safe specifications. This glove fingerprint testing program consists of a number of proprietary risk reduction steps and targeted third-party testing methods, includes gas chromatography combined with mass spectroscopy (GC/MS, surface free energy determination, in vitro cytotoxicity analysis, and microbial viability-linked metagenomic analysis.
With a great deal of faith placed on a glove supplier’s ability to deliver disposable gloves sight unseen, I believe these tests are essential to further reduce the food safety risks associated with them. Objective…Zero surprises!
Michaels, B. (2018). Determination of the % of Foodborne Illness Outbreaks Attributed to Glove-Related Cross-Contamination. Unpublished report
The author would like to acknowledge Barry Michaels, an international scientific consultant on food safety, infectious disease transmission and glove use, who has assisted in the fingerprint testing program discussed in this column.
It is hard to believe that nearly nine years have passed since I joined Stop Foodborne Illness to lead the organization. I will be retiring at the end of May 2019, and many memories will journey with me for the rest of my days on planet earth. I have learned so much through constituents, colleagues and new-found friends. It is so humbling and such a deep honor to serve our constituents. I hold deep gratitude for the individuals and families who give so much during their time of grief while working to improve food safety; they give so freely of their time to share their stories to make a difference for others. It is only for their stories and their sharing that the organization exists. Engaging with food safety professionals throughout the food industry in an effort to improve food safety has been gratifying, and working alongside food safety advocates and consumer groups has been humbling. The staff members at Stop Foodborne Illness are relentless in their commitment and hard work, and they will be remembered. I hope that we leave a mark, a legacy that moved the needle in some small way towards the improvement of food safety. And I hope that the momentum will continue, that there will be people who will not be sick because of the work that has been done under my leadership alongside others, and that the needle will continue to advance forward so that others don’t have to experience the intense and deep pain that comes from being ill or watching a loved one suffer.
I would like to thank Stop’s Board of Directors, who have spent countless hours devoting their time and efforts in their commitment public awareness.
Thank you to everyone who has served as a guide, mentor and friend over the years. You will be remembered. Thanks for all that you do to advance food safety!
Editor’s Note: We would like to that Deirdre for her contributions to Food Safety Tech over the years in the Food Safety Culture column and for her service to the industry. We wish her the best of luck! Deirdre’s cause will continue, as the publication will continue to welcome contributors to this special column.
Yesterday FDA issued an update on the E.coli O157:H7 outbreak linked to romaine lettuce grown in California. The agency’s traceback investigation continues, and it is working with the Public Health Agency of Canada (PHAC) and Canadian Food Inspection Agency (CFIA), as there is a similar outbreak in Canada.
FDA stated that the contaminated lettuce likely originates from the Central Coast growing regions of northern and Central California (Counties of Monterey, San Benito, San Luis Obispo, Santa Barbara, Santa Cruz and Ventura).
“Traceback information from four restaurants in three different states so far has implicated 10 different distributors, 12 different growers, and 11 different farms as potential sources of rthe contaminated lettuce. The information indicates that the outbreak cannot be explained by a single farm, grower, harvester, or distributor.”
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.”
“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.”
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.
We were asked if we think FSMA is driving strong food safety cultures. Our answer is: Yes, but there’s more to the story.
For the dozens of impacted families that advocated for years on behalf of the thousands of individuals who are sickened and die each year from foodborne illness, FSMA marked a sea change in accountability for preventing foodborne illness. And it demonstrated that the consumer voice can impact a Washington legislative process often perceived as impenetrable to the everyday citizen. It’s also true, however, that even before FSMA, leading companies had been implementing modern preventive measures in response to unacceptable illness outbreaks and consumer demands. And food safety thought leaders were writing about food safety culture and working to drive it. We thus see FSMA reinforcing the movement to strengthen food safety cultures rather than being the primary driver.
After all, a genuine food safety culture is as much about people and motivation as regulation. The people in food companies driving strong cultures are motivated at a personal level by knowing the severe harm deadly pathogens in food can inflict on illness victims and their families. And they are motivated at a business level by the realization that the success of a food company hinges on continuously meeting high consumer expectations for food safety. These personal and business motivations are the original and continuing drivers of strong food safety cultures.
The 2011 enactment of FSMA was made possible by the coming together of consumers, food safety experts, and industry leaders who agreed that application of the best available science to prevent problems is the responsibility of everyone. This agreement and the enactment of FSMA powerfully demonstrated how far our food safety culture had come since the uphill battles of 25 years ago over accountability for keeping E. coli O157H:7 out of ground beef and mandating HACCP for meat, poultry and seafood. There is now consensus that adoption of modern preventive controls is a basic responsibility of everyone producing food.
Food safety culture is about much more, however, than simply doing the basics of preventive controls. It’s about staying on top of change in the hazards that occur in our food system and in the means available to minimize them, and being committed to continuous improvement in response to these changes. FSMA took the breakthrough step of making continuous improvement a regulatory requirement by tying the definition of preventive controls to current expert knowledge about how to control hazards and requiring controls to be updated regularly as new knowledge emerges. In this way, FSMA reinforces the movement to strengthen food safety culture and makes it everyone’s responsibility.
But it all still comes back to motivation. Stop Foodborne Illness has long contributed to that motivation by sharing the stories of individuals and families who have experienced devastating loss and lasting harm from foodborne illness. Companies seeking to strengthen their cultures invite Stop constituents to tell their stories in employee training sessions and meetings with senior executives. In this new era of food safety, we see great opportunity to expand collaboration with food companies to help drive the widest possible implementation of best practices, continuous improvement and strong food safety cultures. In this effort, FSMA is our important ally.
Bush and Taylor co-chair the Board of Directors of Stop Foodborne Illness, a non-profit consumer organization that represents victim of foodborne illness and their families.
Last month Chipotle Mexican Grill closed a location in Powell, Ohio after nearly 650 reported illnesses were tied to the location. The outbreak was caused by Clostridium perfringens, a type of bacteria that thrives at room temperature—in other words, food at this particular Chipotle location may have been kept at unsafe temperatures.
Strictly Necessary Cookies
Strictly Necessary Cookies should be enabled at all times so that we can save your preferences for these cookie settings.
We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.
If you visit and/or use the FST Training Calendar, cookies are used to store your search terms, and keep track of which records you have seen already. Without these cookies, the Training Calendar would not work.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
A browser cookie is a small piece of data that is stored on your device to help websites and mobile apps remember things about you. Other technologies, including Web storage and identifiers associated with your device, may be used for similar purposes. In this policy, we say “cookies” to discuss all of these technologies.
Data generated from cookies and other behavioral tracking technology is not made available to any outside parties, and is only used in the aggregate to make editorial decisions for the websites. Most browsers are initially set up to accept cookies, but you can reset your browser to refuse all cookies or to indicate when a cookie is being sent by visiting this Cookies Policy page. If your cookies are disabled in the browser, neither the tracking cookie nor the preference cookie is set, and you are in effect opted-out.
In other cases, our advertisers request to use third-party tracking to verify our ad delivery, or to remarket their products and/or services to you on other websites. You may opt-out of these tracking pixels by adjusting the Do Not Track settings in your browser, or by visiting the Network Advertising Initiative Opt Out page.
You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.
The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.