One person has died (New York City), 12 people have been hospitalized and a total of 47 people have been infected with a strain of Salmonella Kiambu, according to the CDC. Epidemiological and lab evidence points to yellow Maradol papayas as the “likely” culprit of this multistate outbreak.
Thus far, one brand has been linked to the outbreak, Grande Produce, which has recalled its Caribeña brand Maradol papayas distributed between July 10 and July 19, 2017. The CDC will announce other brands once more information is available. During its investigation, an illness cluster was identified in Maryland.
Grande Produce, a distribution center located in Maryland, has stopped importing papayas from its grower and “is taking all precautionary measures to ensure the safety of its imported produce”, according to a company announcement on FDA’s website. According to Grande Produce, environmental microbial testing of its facilities has, to date, tested negative for Salmonella. “Specific sources of what health officials now believe may be two separate Salmonella outbreaks have not yet been determined,” the announcement states.
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.
Last week the CDC announced the end of its investigation involving Shiga toxin-producing E. coli (STEC) in General Mills flour and flour products. However, many consumers may still have these products in their homes, and thus the agency is warning that it expects to see more illnesses. As of September 26, 2016, the CDC recorded 63 infections with strains of STEC O121 or STEC O26 in 24 states, 17 of which resulted in hospitalizations, and no deaths. The agency continues to urge consumers to refrain from eating (this includes a simple “taste”) raw dough or batter. It is also advising against giving playdough made with raw flour to children.
CDC worked with FDA and used PulseNet to identify illnesses that were part of the outbreak. This investigation led General Mills to initiate several recalls of its branded flours (May 31, 2016, July 1, 2016 and July 25, 2016), affecting more than 10 million pounds of product.
“In an epidemiologic investigation, investigators compared the responses of ill people in this outbreak to those of people of similar age and gender reported to state health departments with other gastrointestinal illnesses. Results from this investigation indicated an association between getting sick with STEC and someone in the household using Gold Medal brand flour.
Federal, state, and local regulatory officials performed traceback investigations using package information collected from ill people’s homes and records collected from restaurants where ill people were exposed to raw dough. These initial investigations indicated that the flour used by ill people or used in the restaurants was produced during the same week in November 2015 at the General Mills facility in Kansas City, Missouri, where Gold Medal brand flour is produced,” according to the CDC’s outbreak summary.
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.
Consumers should check their pantry. As a result of newly reported illnesses connected to raw dough or batter consumption, General Mills has expanded its recall of Gold Medal flour, Wondra flour and Signature Kitchens flour to include products made last fall. The FDA and CDC have warned consumers against eating any raw products made with flour.
According to the CDC, the multi-state outbreak of Shiga toxin-producing E. Coli O121 has sickened at least 42 consumers (with 11 hospitalizations) across 21 states. No deaths have been reported. The bacteria was isolated from samples of General Mills flour that was collected from the homes of those sickened in Arizona, Colorado and Oklahoma.
General Mills has already conducted a voluntary recall of 10 million pounds of flour (unbleached, all purpose and self rising). A full list of the products included in the recall are available on FDA’s website.
STOP Foodborne Illness receives many requests to speak at conferences, trainings and meetings. I recently spoke at the Harris County Food Safety Summit in Houston, along with David, one of our Texas volunteers. David became ill from Salmonella after eating at a hospital. The event’s audience consisted of health inspectors, and restaurant owners and managers. It was a great crowd.
At this year’s Food Safety Consortium, STOP Foodborne Illness is holding a fundraiser and honoring heroes in food safety. LEARN MOREAt the United Fresh meeting, I participated on a panel with Rylee, a STOP Nevada volunteer, who spoke about her experiences as a victim of a foodborne illness. Also include on the panel were folks from The California Leafy Green Marketing Agreement to talk about our collaborative training video project. STOP Board Member Jorge Hernandez, also the Chief Food Safety Officer for Wholesome International, moderated the discussion. The video was played (available on STOP’s website). I was asked what I thought about competitive marketing advantage as it relates to food safety. To be honest, I don’t really think about that: STOP Foodborne Illness has an obligation to do what we can to prevent illness and death that stems from foodborne illness. We know that sharing personal stories makes a difference in training.
Now that I’m back in the office, our team has three requests, one for speaking and two requests from media to talk about food safety. We hear a lot about food safety culture these days, but actually taking the steps to facilitate, implement and monitor that change can be more of a challenge. We are reading about so many new technologies and practices related to food safety, which is great, but they must be accompanied by a company’s knowledge and commitment in order to be successful.
We will continue to contribute to the conversation. We are most interested in prevention and in solutions and like you, want to make a difference. We want to have fewer and fewer conversations with devastated family members about their experience with foodborne illness. Thanks again for all you do to create a strong food safety culture. How is your organization instilling a strong culture? Let us know how we can help.
The ubiquitous nature of Listeria has made it a difficult pathogen to detect, control, and find its root cause. Led by Gina Kramer, executive director of Savour Food Safety International, attendees of last week’s Listeria Detection & Control Workshop learned everything from the cost of Listeria ($1.4 million per case and $2.3–$22 billion in the United States annually) to the challenges of breaking down biofilms to the steps a company should be taking to do sanitation right and get rid of resident Listeria in their facility. Here’s a snapshot of what experts said as they addressed industry’s obligation to ensure that their facilities are constantly monitored for contamination to ensure that safe product comes out of their plants.
People equate local and organic with safer, safer, safer. That’s not true, because pathogens are agnostic. – Gina Kramer, executive director, Savour Food Safety International
Whole genome-based outbreak detection allows us to detect more quickly, with greater precision in identifying source — John Besser, Ph.D., Deputy Chief, Enteric Diseases Laboratory Branch, CDC
What’s happening in your plants? What are you taking into your processing plant? What time of year is it coming in? What is your environment—is it more urban or rural? The presence of Listeria isn’t any greater in an urban or rural environment. You might find it in different places, but there isn’t a difference in incidence. – Janet Buffer, corporate food safety manager, The Kroger Co.
Biofilm erupts like a volcano. But once it has erupted, your volcano goes dormant. And for how long? Nobody knows. That’s the problem. The biofilm can release two days later, a week, or a month later. – Dominique Blackman, general manager, Realzyme
Listeria testing is the ugly duckling in preventive controls. Companies need to ask themselves whether the method they use is able to detect potential positives in the environment. – Ted Andrews, senior director, product marketing, Roka Bioscience
Sanitation is not one size fits all. You need to have specific controls in place that look at controlling Listeria not just for equipment but periodic infrastructure and equipment and routines. Validate that they work. Train employees so they properly execute. – Jeff Mitchell, vice president of food safety, Chemstar
You’ve identified Listeria in your facility. Now what? Review touch points: This includes the air, surfaces, transportation and packaging areas. – Troy Smith, CEO, Radiant Industrial Solutions, LLC
If you get everything mostly right, what are the odds that you’ll find a pathogen in end product testing? Getting the proper data point is a big deal. – Douglas Marshall, Ph.D., chief scientific officer, Eurofins
In recent years, several food products typically considered safe by consumers have fallen victim to recalls as a result of Listeria monocytogenes (Lm). Caramel apples, ice cream, packaged salads and frozen vegetables were responsible for sickening dozens of people and killing more than 10. These products are part of an alarming group of common foods that have caused outbreaks, including milk, spinach, sprouts, peanut butter, cheese, cantaloupes and raw cookie dough. And the broad range of pathogens causing these outbreaks is just as diverse, and they continue to find creep into food processing facilities, finished food products and consumer homes.
At the 2016 Food Safety Consortium, Shawn Stevens will moderate the workshop session, Bringing the final FMSA pieces together: You have a basic preventative control program, what’s left? | Friday, December 9 | LEARN MORERegardless of sophistication or expertise in pathogen control, there isn’t a single company out there that is immune to the risk of contamination. Why? Well much of the foods (or ingredients) that we consume are grown and harvested in environments that are susceptible to contamination. Fruits, vegetables and other products, such as spices, can easily become contaminated with Lm, Salmonella or E. coli in the fields where they are grown, in transit or in the processing facilities.
Once pathogens are introduced into the processing environment, they can quickly spread and contaminate food products. Recent studies reveal that Listeria is a significant concern in these environments. For example, out of 5,000 samples from the food preparation areas of 30 retail grocery establishments, approximately 10% tested positive for Lm. These are scary numbers considering almost 16% of those who become infected with Lm will die.
In today’s new environment, FDA will be seeking justification to bring criminal charges whenever a contaminated product causes human illness. You should be nervous about this: If your company sells finished goods into commerce, those products may be selected for sampling and testing, and your company runs the risk that the results will come back positive for a pathogen of concern. And what’s more troubling is the fact that many companies do not conduct environmental testing in their food processing facilities, and so they have no idea whether pathogens (whether transient or resident) are lurking within their facilities. Thus, a microbiological profiling study conducted under the veil of the attorney-client privilege should be conducted to determine the presence of any microbiological persistence issues within a facility. Upon completion of the study, a company should invest in pathogen-reduction technologies to decrease the chances that FDA will uncover pathogens in the environment during an inspection. Finally perform a criminal protection audit to help strengthen company programs and develop protocols that will further protect against criminal exposure.
The bottom line is that if food companies do not take extraordinary measures to identify Lm in their facilities, perform a comprehensive investigation to find the root cause or source, and then destroy and eliminate it completely, the pathogen will likely persist and, over time, intermittently contaminate their finished products.
Microbiological Profiling Studies
Lesson number one from the Blue Bell Lm outbreak is that pathogens can be extremely elusive and, as a result, a simple environmental monitoring program will never save your company from being involved in an outbreak or being the focus of criminal sanctions. All food companies should be aggressively testing for Lm (or other pathogens, depending upon the product risk profile) in their facilities and must take strong action against sporadic or intermittent positive findings. Although many food companies view a single operational failure as the culprit of an outbreak, the reality is that in most cases, the cause is something far more subtle, far more persistent, and far more dangerous. In recent years, a large number of outbreaks have involved Lm and antibiotic-resistant Salmonella that was linked to products that had been processed over multiple months.
Food companies should conduct a comprehensive one-time microbiological profile for pathogens in their processing facilities. Be sure to coordinate your profiling study with a lawyer experienced in food safety to make sure that the study is designed correctly and that the results will be protected under the attorney-client privilege. Once the results are reported, the company can take care of any positive findings, identify the contamination source, implement technologies to reduce and control the contamination, and develop a microbiological control and monitoring program to ensure that the pathogen remains controlled moving forward.
Pathogen Reduction Technologies
The second lesson learned from the Blue Bell case is that, when Lm or any resistant pathogen is found sporadically in the environment, what was once regarded as effective corrective actions (i.e., re-cleaning, re-sanitizing and re-testing) are no longer enough. In addition to existing cleaning and sanitizing procedures, companies should use new pathogen reduction technologies to help control the environment.
Inexpensive air and surface treatment technology that sanitizes the food processing environment is now available. The treatment is approved for use in occupied spaces and provides 24-hour treatment of the environment. By using active air and surface treatment, food processing companies can gain a level of control and decrease the possibility that any pathogen, if introduced, will persist or establish a niche.
Puradigm, LLC, for instance, utilizes a multi- patented, NASA-based active air and surface sterilization approach to control pathogens in the food processing environment. In studies performed by Kansas State University, the company obtained a 2.9 Log reduction on environmental food contact surfaces in the food processing environment. Similar reductions for other pathogens are displayed in Table I.1
I make this observation because, given the risk created by the FDA’s war on pathogens, food companies should invest in technologies to better control pathogens in their food processing environments. Once these preventative technologies are put into place, companies can perform periodic microbiological monitoring to validate that the controls are effective and working as designed. If such solutions are employed, there is a greater likelihood that when FDA arrives to perform microbiological profiling, the agency will be less likely to find positive test results from the food processing environment, better protecting food companies from additional regulatory or criminal exposure.
Criminal Protection Audits
In addition to commissioning microbiological profiling studies in facilities and employing active air and surface sterilization technologies, food companies should also perform internal criminal protection audits. These audits should be designed to identify gaps in existing company protocols and develop written programs designed to help navigate the challenges posed by any food safety issues uncovered.
If developed correctly, the written program should provide the company with a decision-tree to follow in the event of a positive environmental finding, a series of customer complaints relating to the safety of a product, or a notification from a governmental entity of a potential food safety problem. These protocols and programs, if followed in the event of a food safety issue, can help ensure that the conduct of the company in response to any such issues will in all cases be appropriate, and that there will not be any basis upon which FDA or DOJ could support criminal charges.
The FDA (in cooperation with DOJ) has launched a war on pathogens. The agency is targeting food products at retail and engaging in microbiological profiling of all food companies. Unless companies act now to better quantify and control pathogens in the food processing environment, they are exposing themselves to incredible food safety risk, including significant brand damage (in the event of a recall) and criminal sanctions (if their product is linked to human illness). Companies must carefully consider the emerging risks facing them and take measures to decrease and eliminate their exposure.
GC/MS Evaluation of Compounds in Air Samples in a Controlled Environmental Chamber Equipped with a Puradigm Advanced Technology Cell, November 5, 2013, Dr. James Marsden, Kansas State University Food Science Institute.