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.

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

All of us have our personal culture in which we live. How we spend our time at home and on the weekend creates our culture. The time we spend with our neighbors, friends, family and church defines us. Think of the clothes we wear, the food we eat and our traditions. Now think of the culture at your work. Think of the clothes we wear, the rituals in our procedures, and the food we make for customers. What is the status of your food safety culture?

When the FDA inspector visits your facility, the inspector will be looking for evidence of a good food safety culture. If you work in food safety or quality management, you work hard. You wear many hats. When the FDA inspector comes, your records will be inspected, and your employees will be observed. You prepare for that. You have good, organized records. You have good training programs for your employees. Most companies are confident in addressing records and training and making the evidence appear for the inspector. While the inspector is reviewing records and observing employees, the inspector is looking for evidence of a food safety culture. This is touchy-feely and sometimes hard to document. The culture is who you are and how you work together.

What does food safety culture look like? Start with your employees. Are the uniforms clean? Is their footwear of good quality and cleanable? How is their personal hygiene? Do all employees practice good handwashing? These observations plus good recordkeeping lay the foundation of a favorable food safety culture. These parts of a food safety culture are obvious to most and will be discussed more in this blog. In a second blog, I discuss 5 Signs You Don’t Have a Food Safety Culture.

Training records are complete for each employee.
Under the Food Safety Modernization Act (FSMA)’s PCHF rule, training records are required for every employee. The FDA inspector will review your training records as part of a FSMA inspection. Companies earning more than $1,000,000 annually must have a PCQI, and most PCQI will provide a certificate from their training. Going beyond the PCQI, all other employees are qualified individuals, i.e. qualified to do their job. Ensure that your training records are complete, up-to-date, and show how an employee is qualified to do their job.

Your company uses signage.
Show me the sign! We have all seen the sign in the public bathroom stating employees must wash hands before returning to work. I think we get a little numb to the handwashing command. In fact, you cannot invest enough time and resources for proper handwashing. Besides handwashing, we use signs to direct employees to do many things. Signs are great! I am a huge proponent of signs. First, a picture says a thousand words; use pictures on your signs. Make the signs language appropriate for your employees. Use universal symbols as much as possible. Use color. If your employees are getting numb to the signs, move the signs. Change it up. Change the color. Change the shape.

As I travel to different food factories and am escorted into operations, I am always impressed by well-used and maintained handwashing stations, perfectly placed in a transition area and before entering operations. I like to see reminder signs. I love to see posted directions on the proper method for washing hands. My biggest pet peeve with handwashing is people not rinsing and wetting their hands before applying soap. Rinse first! Also, how many of us lather the full length of two “Happy Birthday” songs? That is the minimum time for just the lathering step.

Your company has obvious means for employees to report problems and offer suggestions.
Do you have a suggestion box in the lunchroom? As you observe employees in operations, do they freely discuss concerns with each other and supervisors? There should be an obvious and free exchange of information at all times. A red flag is when an employee is asked a question they should know and states they do not know. Does your company have team meetings with operators? Team meetings should include all shifts and facilitate communication among operators.

I worked with a company where the President sat at the conference table with his Vice Presidents and Managers. Over and over, I witnessed the President shutting down the excuses for food safety shortcomings. He was preaching food safety culture. Sanitation doesn’t have enough thermometers. Buy more. It’s not practical to record data in real time. Find a technology that works in real time. Occasionally a foot foamer is not working. Have a back-up ready to go.

Matthew Botos, CEO of ConnectFood.com, tells us, “Food Safety is ‘Basics Done Well’. As described, risk management best practices start at the top and filter all the way down to every employee and vendor. Food Safety is everyone’s responsibility. There are many tools out there to help companies.”

It is difficult to present a favorable food safety culture and sometimes more difficult to measure. The topic of a food safety culture is new and will develop over time in the food industry. As we continue to talk to each other about food safety culture, we will know it when we see it, and we will be able to measure it.

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

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

A government shutdown looms on today’s horizon

January 19, 2018. There are many federal agencies working for the American people on food safety. Three examples are the Centers for Disease Control and Prevention (CDC) is responsible for monitoring public health, identifying outbreaks, and investigating the source of outbreaks. The Food and Drug Administration (FDA) publishes and enforces laws and guidance for ingredient suppliers and food manufacturers and inspects food companies for compliance with the Food Safety Modernization Act (FSMA) and Good Manufacturing Practices (GMPs). The United States Department of Agriculture (USDA) has parallel duties in food safety to FDA. USDA has jurisdiction over animal products, and FDA gets all the other foods.

CDC. The US is currently in an outbreak of Listeria monocytogenes from potentially from Romaine lettuce. CDC is working closely with Canada, where the outbreak was first identified. There have been deaths. South Africa is currently investigating the largest outbreak of Listeria monocytogenes the world has ever seen. When last I saw, there have been 67 deaths. CDC personnel are certainly in communication with health officials in South Africa to monitor the outbreak and collaborate with food safety officials. Then there is flu season. CDC is responsible for monitoring the cases and number of deaths to track the impact of the flu. With a government shutdown, these non-essential duties and communication may cease, putting millions of Americans in harm.

FDA. FSMA has six laws currently under enforcement. Both the food industry and FDA have been ramping up compliance to the laws. FDA inspectors have been trained and are out doing FSMA inspections. FDA inspections where a user fee is levied will continue. FDA posts recalls daily. With a government shutdown, will recalls be deemed essential duties for the FDA? Will the recalls be announced? Will FDA arrive at the food factory to investigate? Will FDA meetings on recalls be postponed?

USDA. One significant difference between FDA and USDA is that animal slaughter, with subsequent meat packing operations, has mandatory supervision by a USDA inspector. Without the USDA inspector, there is no animal slaughter.

For more details on the affect of a shutdown, go to this PBS article.

Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact Us

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

As I sit drinking my Jamaican Me Crazy morning coffee, I open the newest FDA recall announcement, and it is for Death Wish Coffee’s Death Wish Nitro Cold Brew. First, that’s an unfortunate name given that the recall is for the potential of botulism which is deadly. Putting that aside, I have been waiting for the first recall or outbreak of cold brew coffee. I have been telling anyone who listens that it is only a matter of time before there is a recall or outbreak. The business of food safety is secure.

The beauty of coffee is that it is made with hot water. Most of us have seen on TV or, in some cases, in person the harvesting, gathering, and shipping of coffee beans. The process is nasty. Mud, birds, and rodents are intimately involved in the process. The beans are roasted, but microbiologists like to say, “dirt in, dirt out.” Some of us don’t say “dirt.” After the beans are roasted, they are ground. Have you ever ground beans at the grocery store? I bet that piece of equipment never gets cleaned. What about at commercial roasters? How often does the equipment get cleaned? Or at your gas station/ convenience store? You get the picture.

Again, the beauty of coffee is that it is made with hot water. Folks, this is a needed kill step. FDA recently gave us Chapter 6 of the Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry in draft form. Chapter 6 is Use of Heat Treatments as a Process Control. Every food manufacturer should review this guidance.

This recall of coffee is of canned cold brew coffee. There was no kill step for Clostridium botulinum, and there is the potential for botulism. The company is faced with the fact that they cannot can cold brew coffee without destroying the flavor profile. Smart on their part is to announce that they have suspended the production of this product. It is also smart to work with a process authority like ConnectFood CEO Matthew Botos. There are nonthermal ways to approach the manufacture and packaging of cold brew coffee. That will cost upward of a million dollars, so profit margin needs to be high.

This is what we do at ConnectFood. We support; we educate. Right now though, I need more coffee.

Please comment on this blog post below. I love feedback! Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.