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Food Recalls: Why We Take Them Seriously

In January 2021 a food retailer recalled cartons of their ice cream due to metal fragments in the product. Only one consumer reported metal pieces found in their ice cream; however, due to this incident, as many as 11,000 cartons were recalled due to the concern that there could be metal fragments found in other cartons that were shipped out during the period of production and quality control. A popular microwaveable meal was also recalled recently due to possibility of plastic and glass contamination. Last year, there was also an E.coli outbreak due to Romaine lettuce. This article focuses on how severe recalls can be but the majority of recalls do not pose a threat to human health.

What is a food recall? A food recall is when a food manufacturer must remove their product for consumers to purchase due to reported cases of illnesses caused from the product. Food recalls are common and there have been countless cases of illnesses that have been linked to recalled products. These recalls have affected customers greatly by ways of adverse health consequences, or – in some extreme cases – even leading to death. When individuals go inside a grocery store or market, it is often not their first priority to think about the consequences of what may happen if they were to purchase tainted goods.

There are many reasons why food recalls occur: Biological hazards, misleading claims, chemical hazards, physical foreign objects, and undeclared allergens are all primary reasons. Food can also be recalled if health inspectors spot faults within a food plant and they want to prevent individuals from getting sick. Due to the following reasons, consumers should take major precautions when it comes to food recalls. Food recalls, if they are not followed, have the potential to be detrimental and can lead to further outbreaks of contamination towards healthy individuals. 

As a consumer, what should you do and look out for? It is possible for any food or product to be recalled suddenly. So before running to grab groceries, take a minute to research and keep up-to-date with what goods are under active recall. There are a lot of resources online to do this! Depending what product it is, the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA), have links on their main websites to trace current recalls. When grocery shopping, look at the physical state of the product. One should ask themself – Is it damaged? If yes, then choose another. For individuals that have allergies, read the labels! There can always be undeclared allergens and misleading claims to look out for. Lastly, rinse the produce before use. Not all raw produce goes through a vigorous sanitation process. Food should be disposed when they are recalled. There is also another choice, which is to go back to the store and return the product for a refund. If product is consumed after finding out about the recall – do not panic! Food recalls are often done as a precautionary measure. There are a lot of other precautions to look out for, but these are some of the vital safety measures.

How serious are food recalls actually? Food recalls have become fairly common nowadays, but you should never underestimate the seriousness of the recall. Consumers should double check what they are purchasing to consume and ask themselves: “Is it safe to eat?”

A note from ConnectFood CEO Matthew Botos: When teaching Preventive Controls for Human Foods we look at recall plans as a building block in our overall food safety system. After completion of a company’s hazard analysis and understanding what needs to be monitored and why it needs to be monitored, we create a living recall plan. We must emphasize that an effective recall plan can reduce the financial impact for the company by facilitating rapid retrieval of adulterated products. An effective recall plan can also reduce the number of people who become ill. It is important to note that not all recalls are food safety issues but can come from other issues such as quality, mislabeling, etc. Knowing your product, knowing where that product is distributed, and having a capable team will keep the food supply safe with a recall plan.

If you’re looking for assistance with recall documentation for your facility or products, ConnectFood can help! Contact us today to schedule a consultation for your recall plan, or take a look at our subscription tiers for more services.

About the Author:

Daniela Jugueta received a B.S. degree from SUNY Buffalo State College. She is currently pursuing a M.A.S. degree in Food Safety and Technology in the Food Science and Nutrition department, Illinois Institute of Technology. She is also an intern for ConnectFood as a Food Safety Specialist.

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Food Safety, Jobs in the Time of COVID-19

How badly did I NOT want to put Coronavirus (Covid-19) in the title of this article?
This article is focused on the best practices that we should all be practicing in our food facilities, global pandemic or not. I was torn on the addition of “Covid-19,” but decided to go with the most important things keeping our food manufacturing and food preparations running and keeping jobs and creating commerce: food safety. This article is focused on the best practices that we should all be practicing in our food facilities, global pandemic or not.

“We have always had best practices in sanitation (SSOPs) and good manufacturing practices (GMPs) that are the foundation of our food safety plans.” Said one manufacturer. “Working with organizations like ConnectFood allows us to continue to refine our best practices and paperwork and have continuous improvement on our already stellar best practices.” ConnectFood food is not the only organization (nor anywhere near the largest) tackling global food safety issues and the impact Covid-19 has on our manufacturing.

The above quote is what I really want to talk about. ConnectFood works with thousands of companies to help them understand Good Manufacturing Practices (GMPs), Standard Sanitation Operating Procedures (SSOP’s), and food safety. In a time of crisis, the most important thing to continue is communication. Do all of your employees fully understand the areas of your GMPs and their impact on food safety and human health?

Covid-19 is not a foodborne illness issue, but transmission can be impacted by sanitation and personal hygiene best practices (GMPs).

We can keep producing safe, healthy food with a safe, healthy workforce in this environment. Having all organizations working together in the fight to keep manufacturing growing, collectively we can use the resources set out by Industry, Academia, and Government.

Constant education in a food manufacturing facility is the way we address new, current, and part-time employment. It is the way we address corrective actions. Sanitation and hand washing is not a new concept, but in a time like this we need to make sure all members of our companies understand the importance. Your company should have these practices in place, so a refresher course on the procedures may be wise during this time of heightened awareness for human health for all and encourage your employees to take these best practices home.

Some other questions that we are fielding refer to food that was manufactured in other countries that have been on the news for transmitting cases of Covid-19. The main question has been, “is that food safe?” My response was that if you felt comfortable eating that food in the past, you should continue to use that product from a trusted manufacturer.

What happens if there is an issue?
If public health is notified that a household has had contact or a potential infection, follow guidance from clinicians and your department of public health. In a manufacturing setting, if an employee does not feel “well” they should stay home just as with any illness to prevent spreading it throughout the facility.

Keeping the food supply safe and operating is crucial to all communities around the world so that households not only have food for active healthy lifestyles and the ability to pay bills, but also to enjoy themselves. I suggest to you that food safety plays a monumental role in this and how we address the current Covid-19 situation.

Speak with your employees frequently, but especially more so in a time of crisis or on an allotted timetable. We can all work together to keep a safe and healthy food supply. This includes keeping people at work and in jobs that make a difference.

Here are some links that I found helpful while researching Covid-19:
FDA Resource: https://www.fda.gov/food/food-safety-during-emergencies/food-safety-and-coronavirus-disease-2019-covid-19
USDA Resource: https://www.usda.gov/media/press-releases/2020/03/17/usda-ensures-food-safety-during-covid-19-outbreak

Stay safe, stay healthy, and don’t forget to wash your hands!

About the Author
Matthew Botos is the CEO of ConnectFood. ConnectFood offers an online food safety plan generator to help companies comply with Food Safety Regulations and the Food Safety Modernization Act. ConnectFood provides On-Demand plan reviews and writing services from a national network of food experts. Matthew Botos is the former Director of the Illinois Center for Food Safety and Technology, a non-profit consortium of Illinois food companies, regulatory personnel and academics focused on food safety and the advancement of science and technology for both local and global food sources. Mr. Botos is currently on the Food Safety and Preventive Controls Alliance (FSPCA) International Subcommittee. He is also one of approximately 40 approved Train the Trainer instructors of the FSPCA Lead Instructor program launched in October 2015 and has taught over 1,000 of the nation’s leading food safety experts.

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Romaine Recall – Round 2

CNN Lets ‘Food Babe’ Spout Pseudoscience on Lettuce Outbreak
There’s another wonderful headline. Everyone has something to say about Romaine lettuce and pathogenic E. coli. Everyone I know anyway. I do not spout pseudoscience, but I have previously written about our first Romaine recall of 2018 here, and I use credible sources for my information like CDC and FDA.

The United States is currently in a second E. coli O157:H7 outbreak linked to Romaine.
Our friends to the north in Canada are with us in this outbreak too. The CDC reported on November 26, that 43 cases in the US have been diagnosed across 12 states, with 16 hospitalizations and no deaths. The illness for at least one person has resulted in hemolytic uremic syndrome (HUS), i.e. kidney failure. The outbreak started the beginning of October, and more cases are expected to be reported.

Romaine is currently not harvested from Arizona.
The first 2018 outbreak of pathogenic E. coli was traced to Romaine grown in Arizona. It took some time to detect, but the source of the Romaine for the current outbreak is California, not Arizona. In fact, the search has narrowed to six counties in California where Romaine was grown and harvested.

Where was my Romaine grown?
In the last outbreak, family members were asking me if they really had to throw away the old Romaine in the refrigerator and the fresh Romaine they just bought at the store. Yes! All Romaine was discarded in the supply chain. Growers, processors, stores and restaurants are understandably upset at having to dispose of Romaine again. Thanks to government and industry working together, FDA is urging processors to label Romaine with used by dates, harvest location and harvest date.

Do you remember the outbreak of 2017?
Yes, we were in a similar spot a year ago with an E. coli outbreak in the United States and Canada. Data pointed to leafy greens, but the source of the outbreak was never found, and a recall was never announced by the FDA. Canada’s traceback investigation landed on Romaine as the source. In the US, there were 25 cases across 15 states with the outbreak starting the beginning of November. By the end of February, two people had HUS and one person had died. Canada saw 42 cases and one death.

Are all these E. coli the same? No, and Maybe.
No. The FDA states that the E. coli O157:H7 from the first outbreak of 2018 and from Arizona Romaine is different genetically from the E. coli O157:H7 of California, like non-identical twins. Close, but not the same.
Maybe. However, when comparing the E. coli O157:H7 of the current outbreak to the E. coli O157:H7 of the outbreak this time last year, they are identical twins:

    Genetic analysis indicates that illnesses reported in this current outbreak are caused by the same strain of E. coli O157:H7 seen in a previous outbreak that occurred in fall of 2017 that affected consumers in both Canada and the U.S.

Smart people are working on this problem in the United States and Canada. In the meantime, toss away any Romaine you have in your refrigerator. Recalls are stressful situations. The Preventive Controls for Human Food rule under FSMA requires a written recall plan.

ConnectFood can help you meet the requirement of the rule and be prepared for a potential recall. The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting LLC
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she has delivered over 20 workshops to the food industry. With 35+ years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an active communicator at all levels of an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in the prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd.

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FDA Will Initiate A Recall if a Company Does Not

“FDA Seizes Food and Medical Products Held Under Insanitary Conditions at an Arkansas Grocery Warehouse.” This FDA News Release grabbed my attention. I have known since my first year of Food Science courses that FDA has the authority to seize product but does so rarely. After the Department of Justice filed the complaint in a U.S. District Court, armed marshals of the U.S. Marshals Service entered the Alma, Arkansas warehouses to detain products and keep products from entering interstate commerce. Does this sound like too much authority? This is from the FDA News Release:

    The complaint alleges that an inspection of J and L Grocery that the FDA conducted in September and October 2018 revealed insanitary conditions including multiple live and dead rodents, rodent nesting, live racoons, live cats, a dead possum, animal feces, and urine-stained products in and around the company’s seven warehouses and sheds used to store food, medical products and cosmetics.

The FDA got its hand slapped when the Office of Inspector General published findings in a 53-page report in 2017 detailing:

    FDA could not always ensure that firms initiated recalls promptly and that FDA did not always
    (1) evaluate health hazards in a timely manner,
    (2) issue audit check assignments at the appropriate level,
    (3) complete audit checks in accordance with its procedures,
    (4) collect timely and complete status reports from firms that have issued recalls,
    (5) track key recall data in the RES [Recall Enterprise System], and
    (6) maintain accurate recall data in the RES.

Remarkably, FDA agreed with the findings and started addressing the deficiencies before the final report was published. FDA was given more authority under the Food Safety Modernization Act (FSMA). My previous blog post described the first uses of FDA’s FSMA authority, including the first mandatory recall for a dietary supplement, kratom.

FDA has stepped up the game by publishing FDA Statements from FDA Commissioner Scott Gottlieb [author’s note: I find these FDA Statements very helpful], a final guidance of Questions and Answers Regarding Mandatory Food Recalls, and two draft guidance documents – Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls and Public Warning and Notification of Recalls. These documents coming from FDA allow us to get inside the head of FDA, learn the expectations for a recall, and work cooperatively with FDA in recall situations. I have been present at the start of recalls with industry and have been brought in for root cause analysis after the announcement of recalls. During crisis management in the food industry there is always the question of what FDA will do. Through these documents, FDA is telling us what they plan to do. Here is part of the Commissioner’s statement:

    The guidance further outlines how the FDA will give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall, as the law requires. It offers more detail about the evidence or circumstances the FDA may consider when deciding to move forward with a mandatory food recall and provides clarity around situations when the FDA would deem a food product a serious health risk. Providing this additional clarity can enable the FDA to make more robust use of this recall authority.

Recalls are stressful situations. The Preventive Controls for Human Food rule under FSMA requires a written recall plan. ConnectFood can help you meet the requirement of the rule and be prepared for a potential recall. The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

From Dr. Kathy Knutson, a photo from the U.S. Department of Justice, Marshals Service.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting LLC
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she has delivered over 20 workshops to the food industry. With 35+ years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an active communicator at all levels of an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in the prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd.

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Recalls

Last week we talked about the importance of mock recalls. It was inferred that companies find mock recalls painful, but maybe some companies love them. That being said, mock recalls are crucial to the survival of a company if a full recall is necessary. “The Preventive Controls for Human Food regulation requires the development of a written Recall Plan when a hazard analysis identifies a hazard requiring a preventive control.” The rule discusses “reviews definitions of recall classes, required elements of a Recall Plan, who to notify when a recall is necessary, how to conduct effectiveness checks and methods that can be used to dispose of affected product.”

Recently I received a call and a company had an adulterated product from a source overseas. The call started with an attorney and ended with company management over a series of conversations in just days. The outcome was a Class III recall, and it was not a danger to human health – just an ingredient that was not for use in the United States. The company took all of the right actions and, even though a tremendous amount of work was put in over a short period of time, the proper actions were followed. This is why mock recalls are so important for the viability of a company. Knowing what to do and having an internal team and external advisors can and will save time, money, and possibly a brand if handled correctly.

“Recalls are actions taken by an establishment to remove an adulterated, misbranded or violative product from the market. In other words, a product for which FDA or a state could take legal action against the company would be subject to recall. If a company withdraws a product that does not violate food law or the product has not entered the marketplace, these situations dealing with quality issues are not usually considered recalls but may be considered a stock recovery or market withdrawal. Three classes of recalls are defined based on the potential health effects.

    • A Class I recall is the most serious and involves product that has a reasonable probability of causing serious injury, illness or death.
    • Class II recalls may cause temporary illness that typically resolves in full recovery. For Class II recalls, death and other serious consequences are not likely.
    • Class III recalls are not likely to cause illness but are still in violation of the law. Typically, a company voluntarily conducts a product recall, either on their own accord or at the request of FDA or a state.

FDA has the authority to require a company to conduct a recall in Class I situations.” (Preventive Controls for Human Food Curriculum)

The largest factor in determining a recall is understanding your hazard analysis. If you do not understand where a person is reasonably likely to become injured or ill then your company cannot fully implement a product’s recall. There are many factors that work in conjunction with one another to establish when a recall should be implemented. You must understand your process and what products are coming in as ingredients and what products are leaving your facility. A Class I, II, or III recall may not even be your company’s fault from the beginning. For example, a company could receive an adulterated ingredient or could have been shipped the wrong labels. However, a company could also be at fault because they did not properly check their labels or they could not have followed another preventive control that allowed for a product to be potentially harmful to the consumer.

I have been involved in a Class I recall where the manufacturer had data that led the regulatory authority to believe that a raw material came from a supplier that had a pathogen in the raw material. At this point, the game changes because a company must find and isolate any potentially adulterated product. They must then work with the recall team to make sure that specific product has not been sent to the consumer until such time as proper testing and evaluation of the product has been conducted. These recalls are time consuming and are tough decisions that must be made – but ultimately the safety and the security of the food supply in the most important factor.

Recall teams are critical to the process of deciding when a recall is necessary and what is to be done in case a recall is, in fact, initiated. “The owner, operator or agent in charge of a facility is accountable for the safety of the food and must ensure that a Recall Plan is written. A recall coordinator and recall team are typically identified ahead of time. The recall team should include all functions necessary to collect accurate and complete information. For example, production, shipping, quality assurance, sales and administrative personnel should be considered as members of the recall team. If the firm has multiple locations, the team may include corporate team members from different departments (e.g., safety, quality assurance, distribution, etc.). Each recall team member should have clearly defined roles.”

A recall plan must have a hazard analysis and dedicated team to make sure that an effective recall, if necessary, can be completed with maximum efficiency. There are many ways to have your written documentation to prepare for a recall and there is an abundance of work that must be completed before, during and after a recall. If you have a recall you must be prepared for one and understand the impact, you must be ready to act and you have to have programs in place to implement documented corrective actions. connectfood.com has recall planning tools available for companies, so if you need help we are here for you to contact at connectfood.com.

About the Author
Matthew Botos is the CEO and Founder of ConnectFood. ConnectFood offers a step-by-step, “Do-It-Yourself” food safety plan generator to help companies comply with the Food Safety Modernization Act and On-Demand plan reviews from a national network of food experts. Mr. Botos is currently on the Food Safety and Preventive Controls Alliance (FSPCA) International Subcommittee. He is also one of few approved Train the Trainer instructors of the FSPCA Lead Instructor program launched in October 2015 and has taught over 800 of the nation’s leading food safety experts.

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E. coli Outbreak Update Linked to Romaine Lettuce

It has been two weeks since the CDC updated the case count and epi curve on their website. The reasoning is good, because the outbreak of E. coli O157:H7 associated with Romaine lettuce is mostly over and data are arriving more slowly. There is no Romaine lettuce from the Yuma, Arizona growing region being harvested. All Romaine lettuce from the Yuma growing region is beyond its shelf-life and is no longer being consumed. The public health community is waiting for the reporting of any new cases and the fate of those stricken with the illness. It is sad to report that the death count raised from one to a total of five souls.

A look at the epi curve shows a normal distribution of cases, a week where the number of cases dwindled to single digits and days without new cases, great signs that the outbreak will soon be declared over by the CDC. An onset time of three weeks is possible coupled with time for medical diagnosis and reporting to CDC means there may be more cases reported. The case count currently is 197.

There are several striking features of this E. coli O157: H7 outbreak:

    • 89 people have been hospitalized. A hospitalization rate of 45% is high.
    • Similarly, the rate of patients developing hemolytic uremic syndrome (HUS), a form of kidney failure, is high at 13% for 26 people.
    • E. coli O157:H7 with the same DNA fingerprint and associated with Romaine lettuce caused illness in Canada.
    • Illnesses have been reported in 35 states, including Alaska.

While the CDC continues to monitor the outbreak and many organizations, including the FDA, are investigating, one of the most striking features is that no Romaine lettuce is available for pathogen testing. Because of the typical, long onset time for the illness, any unconsumed Romaine is long discarded. Most outbreak investigations will gather samples from consumer homes, restaurants and grocery stores. In this outbreak, the implicated product availability is very limited. The outbreak investigation is very difficult as illustrated in the traceback model created by the FDA and showing some of the traceback for Romaine lettuce. With no common point of service, distribution center or processor, the source of contamination may be found in the growing region.

All this news should cause us to take a hard look at our own recall plans. If your company is audited, mock recalls are conducted at some frequency, and there are always learnings from mock recalls. If you are under compliance for the Preventive Controls for Human Food rule, a written recall plan is required as part of the food safety plan. I encourage you to take time now to review and update the recall plan. From my experience of working with companies on recall investigations, it is better to take time now to be prepared than to be figuring this out during a recall. The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

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E. Coli Outbreak in Romaine Lettuce: What You Should Know

May 2, 2018 Update
Both the FDA and CDC published updates on the pathogenic E. coli outbreak today. Sadly, one death was reported. This blog post was published earlier in the day and has been updated below the original post.

Romaine Recall: What You Should Know

There is an outbreak of pathogenic E. coli in the US. The Centers for Disease Control and Prevention (CDC) through PulseNet, a national database, recognized the outbreak in March 2018 with the initial CDC announcement on April 10, 2018. With the initial announcement, there were 17 cases across seven states with the largest number identified by the New Jersey Department of Health.

What do we know about the outbreak?

    • The pathogen is Shiga toxin-producing Escherichia coli O157:H7.
    • The likely source is Romaine lettuce.
    • The Romaine lettuce is from the Yuma, AZ growing region.
    • Illnesses started March 13th, 2018.
    • 22 states.
    • 98 cases ranging in age 1-88.
    • 46 hospitalizations, including.
    • 10 patients with hemolytic uremic syndrome, a form of kidney failure.
    • 0 deaths reported.
    • 65% of cases are females.
    • Dozens of farms in the Yuma, AZ region are being investigated.

How do we know what we know?

    • When a clinical isolate from a patient is identified as E. coli O157:H7, the result is reported to the state department of health. The state reports the result to the CDC. The isolate is tested by pulsed field gel electrophoresis (PFGE) and the data are entered in the national PulseNet database. The CDC monitors the database and sees the matches across multiple states. There are differences in strains of E. coli O157:H7, and PFGE is used to show matches of the same strain. The outbreaks isolates are also tested by whole genome sequencing (WGS), a method to fingerprint the strains.
    • Health departments conduct food surveys of patients to learn foods eaten. For this outbreak, 64 of 67 patients interviewed reported eating Romaine the week before the illness started.
    • The Yuma, AZ growing region provides Romaine to the US during the winter growing months.
    • The CDC epi curve shows the first case had an illness start date of March 13th.
    • The CDC Case Count Map shows the number of cases per state.
    • E. coli O157:H7 was traced back and found from one farm in Yuma, AZ, after cases developed at a correctional facility in Alaska where whole-head Romaine was shipped. This one farm has not been called the sole source of the outbreak, and the investigation continues in the Yuma, AZ growing region

What do we expect?

    • Illnesses started after April 7th may not be reported yet, so the number of cases will increase. The timeline for the illness and outbreak is:

      1. Onset time is 1-8 days.
      2. Duration of the illness is 5-10 days.
      3. Medical diagnosis can be 2-3 weeks.
      4. PFGE and WGS conducted.

    • Watch for another CDC update on the number of cases and hospitalizations.
    • The investigators will locate the source of E. coli O157:H7. The isolates will be tested by PFGE and WGS. The results from the source will be compared to the patient isolates to detect matches.
    • The number of cases will taper off and the outbreak will be over, due to the end of the Romaine growing season in Yuma, AZ.

What can you as a consumer do?

    • Do not eat Romaine from Yuma, AZ or if the growing location is unknown.
    • Do not eat salad blends containing Romaine, if the growing location is unknown.
    • Do not eat salads, if you do not know if the salad contains Romaine.
    • As we start the summer season, follow the rules of clean, chill, cook and combat cross-contamination.
    • Finally, my favorite rule is, “When in doubt, throw it out.”

Updated information from the CDC and FDA, May 2, 2018

    • The last reported illness started on April 21, 2018.
    • The number of states has increased to 25.
    • The number of cases has increased to 121.
    • The number of hospitalizations has increased to 52.
    • The number of patients with hemolytic uremic syndrome is 14, up from 10.
    • California reported one death.
    • CDC investigations are ongoing.
    • As expected, the growing season is over for the Yuma growing region as reported by the Arizona Leafy Greens Marketing Agreement on April 27, however, Romaine has a 21-day shelf life which puts Romaine with consumers until mid-May or longer.

Because of the timeline for illness and outbreak detailed above, additional cases are expected. I want to note that growers who participate in the Arizona Leafy Greens Marketing Agreement implement strict procedures for food safety. The grower who sourced to Alaska is an active participant in the Agreement and highly regarded for compliance in food safety. Participants must have a food safety plan, employee training in food safety, pass an audit and pass inspections. I hope that the source of the contamination is discovered, and the growers will come back even better than they already were. Food safety is not competitive, and we are all in this together.

Correction: The original blog stated that E. coli O157:H7 was found from one farm in Yuma, AZ. That is not correct as the FDA continues to investigate the source of the pathogen along the supply chain. FDA traced the source of the Romaine shipped to Alaska back to one farm in Yuma, AZ.

The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

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FDA Uses New Authority Under FSMA to Order a Mandatory Recall

This week was a historic week for the federal Food and Drug Administration (FDA). Three times since the signing of the Food Safety Modernization Act (FSMA) in 2011, FDA has used its new authority, i.e. new tools to prevent illness or injury from food. In 2012, FDA suspended the facility registration of Sunland, Inc. of Portales, New Mexico, a manufacturer of peanut butter. In 2013, FDA sent a Notification of Opportunity to Initiate a Voluntary Recall to Kasel Associates Industries, Inc., a manufacturer of pet treats. This week, FDA ordered a mandatory recall of kratom products from Triangle Pharmanaturals, LLC of Las Vegas, Nevada.

The FDA used its authority under FSMA to order a recall. This is a big deal. In all the history of food safety and the FDA, this is the first time the FDA has announced a mandatory recall. There have been thousands of recalls in FDA’s history, and before this week, every single recall has been voluntary and announced by the company.

What were FDA’s options before FSMA? Traditionally, FDA has followed up inspections with Form 483. Observations are detailed on Form 483, and the company must respond with corrective action to each observation. FDA has written soft letters, had phone conversations and sent email messages to communicate. Beyond communication and for more action, the FDA sends Warning Letters and can go to federal court to seek either an injunction to halt sale of product or an order for seizure of product. Product seizure can be taking product off store shelves or stopping finished product from entering commerce. Those are a lot of options! In the three cases stated above, FDA used many tactics to communicate and work with the companies, before getting to the last straw.

Case 1. Sunland peanut butter sold finished product containing Salmonella.
A little research on Sunland shows a long history of peanut butter recalls and FDA communication from 2009 to 2012. Just a year and a half after President Obama signed FSMA and four years before the food industry came under compliance and enforcement, the FDA exercised its new authority. For my readers who favor less government and less rules, look at what FDA did before pulling Sunland’s registration:

    1. 2007: Form 483 following inspection 10/25/2007
    2. 2009: Form 483 following inspection 3/10/2009
    3. 2010: Form 483 following inspection 9/23/2010
    4. 2011: Form 483 following inspection 3/25/2011
    5. 2012: Form 483 following inspection 10/29/2012

For the 2012 inspection, FDA was on-site for one month and listed the details of ten observations. Given authority under FSMA, FDA was able to stop production of Salmonella-laden peanut butter. The Centers for Disease Control and Prevention (CDC) reported the Salmonella outbreak from Sunland peanut butter covered 20 states and was responsible for 42 cases. Children under 10 were 61% of the cases, and 28% of cases were hospitalized. We know that diagnosed and reported illnesses represent a small portion of all persons with illness from an outbreak. Dozens of companies using peanut butter in their products went through subsequent recalls because of the peanut butter recall. I know, because it was my job to follow recalls and post them to ConnectFood’s Twitter.

Case 2. Kasel dog treats recalled after Salmonella found.
FDA has authority for enforcement and compliance over animal food. In February of 2013 Kasel was manufacturing dog treats and was re-inspected. In a 2012 inspection, Salmonella was found in the dog treats, in the processing environment, and on food contact surfaces. FDA inspectors cited problems with Kasel’s Good Manufacturing Practices including building repair, pest control and cleaning and sanitizing procedures. The dog treats had either a one-year or two-year expiration date. Kasel was given two days to initiate a voluntary recall after receiving FDA’s Notification of Opportunity to Initiate a Voluntary Recall, and Kasel complied by announcing a voluntary recall on February 19, 2013. Here’s my favorite sentence from the Notification: If you do not voluntarily cease distribution and conduct a recall in the time and manner described in this section, FDA may, by order, require you to immediately cease distribution of the affected pet treats. Fast-forward to 2018. FDA is rigorously inspecting animal food manufacturers, and we have seen a wave of pet food recalls [author’s note: choose Animal Health for from the drop down menu of recall categories], primarily of raw pet food.

Case 3. Triangle Pharmanaturals’ kratom products contain Salmonella.
Remember all those options available to the FDA? It seems the FDA used them and got no response from the company in return. FDA sent Triangle Pharmanauturals a Notification of Opportunity to Initiate a Voluntary Recall with no response from the company. All companies in the past which have received this letter from the FDA have followed up with a voluntary recall, because this is the first company which has not! This is the evidence I have gathered against Triangle Pharmanaturals. There is currently (April 2018) a multi-state outbreak of Salmonella. During interviews in March of people ill from Salmonella, when specifically asked, 40 of 55 reported consuming kratom before getting sick. Salmonella has been isolated twice from Triangle Pharmanaturals’ products by the state of Oregon and four times by FDA. Triangle Pharmanaturals’ competitors have recalled their kratom products. As I am writing this, I received updated recall information to include 38 states and 132 confirmed cases.

These three companies have in common that their products contained Salmonella. To me as a microbiologist, that is interesting. More importantly, their company names are forever tied to the history of FDA in the fight of foodborne illness. Personally, I am thankful for the work of the FDA and CDC.

The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

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Enforcement Reports for Class II and Class III Recalls Offer Help to the Food Industry

I subscribe to alerts for Class I recalls from the Food and Drug Administration (FDA). The message goes to my email with a link to the press release. It’s a great automated system, and the number of alerts is small enough to manage daily in email. The FDA recalls more than just food – their recalls include biologics (medical products), animal health products (pet food), medical devices, drugs, cosmetics and tobacco. I didn’t sign up for everything, and the subject of the emails I receive helps me decide which ones I can delete without opening… efficient.

Class I recalls are announced when there is a large possibility a consumer will become ill or be injured from a food they have ingested; think of glass shards or pathogens in food. This is where the food industry spends research dollars and companies take measures to prevent biological, chemical, and physical hazards. Class I recalls are the ones we see in social media, which are heavily communicated on the news and posted about on the FDA website. Class I recalls must be entered into the Reportable Food Registry. Do you know what hazard is the number one cause of Class I recalls? The answer is… allergens: a chemical hazard. You cannot put too many resources into allergen management if your product contains an allergen.

I was recently reminded by a colleague to keep up with the Class I notices (done!) and enforcement reports. Hmmm, enforcement reports? In FDA’s words:

    “All recalls monitored by FDA are included in the Enforcement Report once they are classified and may be listed prior to classification when FDA determines the firm’s removal or correction of a marketed product(s) meets the definition of a recall. Once FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification.”

“Classified” does not mean the recall is top secret! There are three classes; Class I is discussed above as the most serious among the classes. A Class II recall is a situation where the probability of illness or injury is remote. Only the manufacturer can make the call on if the recall will be classified as Class I or II based upon the specifics of what went wrong. The situation has a possibility of illness or injury, but the chances are so small that the conditions for illness or injury are unusual or unlikely. A Class III recall is not likely to cause any illness or injury. Period. It absolutely will not happen. The fourth option in an enforcement report is “pending.” This means the FDA is still considering the class for the recall. You would think this is pretty straight forward, but recalls are one big bell curve. Class I and Class III extremes are easy to get right, but there is a huge bump in the middle for Class II. This leads me to the FDA website.

Enforcement reports are posted weekly. When you go to the previous link, click on the week of interest, then sort with the ‘Product Type’ dropdown menu for ‘Food’ or another category. Dietary supplements are posted under ‘Food,’ even though they are not food and are separately regulated. If you really want a scare, choose the category of ‘Drugs’ to see all the problems in that industry, or see pending recalls of drugs. In addition to the Class I recalls, the other classes are of interest as well.

We use enforcement reports to keep up with our industry. What problems do others in your commodity experience? When we read the Class II and Class III recalls, we see what problems are occurring in our industry. Are you in dairy, flour, nuts, or produce? Look for companies with similar commodities as both your ingredients and your products. As part of reviewing your written food safety plan, the food safety team is required to keep up with current science and potential hazards. One way to know what is going on in your commodity is to keep up with enforcement reports.

Have you heard all the recalls of pet food? These are not coming to my email, so I need to update my alerts. The ConnectFood website has free resources, including the ability to create a recall plan for your facility and products using the online software. The folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

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FDA Listeria Draft Guidance for Ready-to-Eat Foods: Part 2

I first learned that Listeria monocytogenes is a foodborne pathogen in 1985 during the Jalisco cheese outbreak in Los Angeles and Orange Counties in California. There were 29 deaths from 86 documented cases. The veterinary world was very familiar with Listeria in cattle, long before food microbiologists. Industry and the federal Food and Drug Administration (FDA) took this emerging pathogen seriously. Since 1985, there has been active research and investigations at universities and food companies. We know that Listeria is ubiquitous, and current lab methods improve our chances of finding Listeria.

FDA Listeria Draft Guidance for Ready-to-Eat Foods: Part 1, published previously at connectfood.com, discussed Listeria testing on food contact surfaces (FCS) and non-food contact surfaces (NFCS) and from finished product. We encourage you to study FDA’s draft guidance, Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry. Here, I present three concepts needed to understand the information in the guidance.

A positive Listeria test from a FCS assumes the presence of Listeria in your product.

The guidance for ready-to-eat food recommends FCS be sampled after three hours of production and five FCS samples be collected per week per line. First consider these sample sites. The FCS sites should be after the final kill step. It does no good to sample FCS sites before the final kill step. If the test is positive, the assumption is that the final kill step killed the pathogen. The FCS sites are before the final product is sealed in packaging. Think about the distance where your product travels after the final kill step to where the package is sealed. In that distance, think about where the product is open to the environment. Listeria is an environmental pathogen. What I mean is if the product is in tubing, the product is not exposed to the environment, and these would not be FCS sites for Listeria. I am thinking about an ice cream plant. The mix travels through tubing until carton filling. The distance the product travels from the end of the tube to the carton is small, and the distance the open carton travels until sealed is small. Compare that to a large bakery. After leaving the oven on conveyor belts, the baked goods travel open to the environment for cooling and the addition of toppings. I have seen distance as long as 50 yards with the transfer onto multiple conveyor belts.

Once you have your FCS sites identified and if a FCS test is positive, it is assumed the product is positive, even without direct sampling and testing of the product. This makes sense. If a FCS is positive, the product touched the FCS. At that point it’s a chicken-and-the-egg discussion of whether the product contaminated the surface or the surface contaminated the product. It doesn’t matter until you do your root cause analysis. What you do know is that you have contaminated product.

A positive Listeria test from an environmental sample has an isolate identified as Listeria innocua or another Listeria species; consider Listeria monocytogenes as present.

Listeria monocytogenes is one of 17 species of Listeria. Only the species Listeria monocytogenes is considered a foodborne pathogen. When your contract lab tests for Listeria genus or spp., a positive test does not tell you the species. Further testing can identify the species, if needed. It is very common for the lab to report negative for Listeria monocytogenes and report the presence of Listeria innocua instead. In no way can you rest easy with a positive Listeria test and negative Listeria monocytogenes test. When the lab reports a positive Listeria test, consider Listeria monocytogenes present.

Consider the sampling site and technique. Let’s use the example of a drain swabbed with a sterile sponge. Assume Listeria monocytogenes is there. Perhaps the sponge did not swab the location of the pathogen. Perhaps the sponge did not get through the layers of goo where the pathogen is harbored. There are many reasons for missing the pathogen in the procedure for swabbing. If the test is positive for a different Listeria species, the conditions at that site are conducive for the presence of Listeria monocytogenes. Corrective action must be done in the same way as if the test were positive for Listeria monocytogenes.

Consider the variety of microflora at the site. The site was not sterile and does contain diverse types of bacteria at different numbers and proportions to each other. Listeria monocytogenes is the wimpy kid on the playground. Listeria innocua outcompetes Listeria monocytogenes not just 10-to-1, but as much as 20:1 or 50:1! The mere chance of finding Listeria innocua instead of Listeria monocytogenes is simply greater. Listeria monocytogenes may have been present in the sample, in the testing, and simply not detected.

An environmental sample tests positive for Listeria genus or Listeria species (spp.); react as if the sample were positive for Listeria monocytogenes.

You will direct the lab in what method to use and at what point to stop the testing. Work with the contract lab in making this determination. After a positive test for Listeria genus or spp., you have the option to continue testing to identify the isolate of Listeria. This costs more money and time. Will you do something different with that information? No! It is not necessary to confirm the presence of Listeria monocytogenes from a positive Listeria genus or spp. test, when your corrective action is the same. Think this through before testing. Know the action the plant will take when a Listeria genus or spp. test is positive. Expect to get positives from zones 3 and 4. FDA inspectors should not have a problem with seeing occasional positive tests. Since Listeria is ubiquitous, you are expected to find it. The important part is what you do as corrective action. Follow-up testing should be negative to prove Listeria is eliminated from the site and the area adjacent to the site.

As you work through the FDA Listeria guidance, the ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

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