How a Government Shutdown Affects Your Food Safety

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 Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through, 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

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What are Preventive Controls in the Food Industry?

Preventive controls are actions your company takes to ensure the product is safe. The FDA recognizes five types of preventive controls in the Preventive Controls for Human Food rule. They are process, allergen, sanitation, supply chain, and other preventive controls.

Food companies with more than $1 million in annual revenue are required under FSMA’s Preventive Controls for Human Food rule to conduct a hazard analysis and identify preventive controls. The company will consider biological, chemical, physical, and radiological hazards. The hazard analysis drives the discussion and decisions on preventive controls. For every hazard, there are actions the company takes to control the hazard.

Most food companies have a process preventive control and monitor time and temperature. The time and temperature are combined to control a biological hazard. Most companies have a metal detector, inspection of packaging to match the product and label allergens for an allergen preventive control, and monitoring of sanitation preventive controls for the control of environmental pathogens. FDA’s current thinking on environmental monitoring is detailed in the draft Listeria guidance. Process preventive controls and sanitation preventive controls may be designed to prevent foodborne illness, but did you know most recalls are due to the hazard of allergens? The food may be perfectly made, but if the packaging is wrong, the company will have a recall. Follow this link for just one example.

Some companies have so many redundant steps that it is difficult to name the step which is a preventive control. In this case, the food safety team should talk through their process and imagine taking away a step. I talked with a company that had multiple filters for their stream of product. To name every filter as a preventive control creates a lot of work and is unnecessary. Failure of the first filters was not a food safety issue because later filters work. The company visualized which filters were the most important for food safety by visualizing the removal of each individually. Where failure could result in a food safety hazard, the step was named as a preventive control.

If the hazard is controlled by the supplier, the receiving company must verify the hazard was controlled. An example is ice cream inclusions, like nuts. Imagine how the receiving company could verify the safety. COAs of course. Will the supplier share their food safety plan? An audit is required. Does the supplier have a validated process? Supply chain preventive controls are all about verification.

In addition to the four types of preventive controls mentioned above, the FDA also gives industry the option of other preventive control. I look at this type in two ways. First, your food safety team may disagree on naming the type of preventive control. For example, is an allergen clean a sanitation or allergen preventive control? It doesn’t matter! It only matters that it gets done. The second way that other can be used is if new scientific information emerges and does not fit into one of the four types of preventive controls. Current scientific understanding (below) means that we are always learning, and new information on hazards is always emerging. With the latest information, a company may need to reanalyze their food safety plan.

Here is the definition of preventive controls from the rule:

Preventive controls means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.”

The knowledgeable person ultimately is a Preventive Controls Qualified Individual (PCQI) in cooperation with engineers, microbiologists, and other food safety experts. The PCQI works with his or her food safety team to write the hazard analysis and identify preventive controls. The food industry has trained over 40,000 PCQIs in less than two years. PCQIs are your go-to people for food safety. If you are a small company in need of food safety expertise, the folks at ConnectFood are here to help.

Please comment on this blog post below. I love feedback! Still have questions? The ConnectFood website has free resources; click here to 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

September 18, 2017: Enforcement Date for Food Safety Plans

I am writing this on September 18th, 2017. For over a year I have trained people in workshops that this date is the FDA enforcement date for all food companies as regulated under the Food Safety Modernization Act (FSMA)’s Preventive Controls for Human Food rule. The small companies had more time for compliance, but this is it. Time is up.

Going forward from this day, all food companies in the United States earning more than $1 million in annual revenue must have a written food safety plan. The written food safety plan starts with a written hazard analysis and ends with a written recall plan. The food safety plan must meet the requirements in Subpart C of the Preventive Controls for Human Food rule. Today changes the way I teach, the way FDA enforces, and the way food companies prove food safety.

Even though today is the day, word on the street is that the FDA is a little behind on FSMA inspections. The FDA has done a great job training inspectors, providing guidance, and giving inspectors the tools they need. I hear that FSMA inspections will be more like audits: with the emphasis on review of the food safety plan and employee training records. There will be less time walking the line and more time reviewing monitoring and verification records. That being said, most FDA inspections are still for Good Manufacturing Practices, found in Subpart B of the Preventive Controls for Human Food rule. If your company manufactures a product that has been recalled by a competitor or is known to be under high scrutiny by the FDA, then you should be prepared for an inspection in the near future. If not, you may have more time to prepare.

Are you feeling overwhelmed? Did you find this blog post because your food safety plan is not finished or you feel it is lacking? I do not want you to feel alone or isolated from the resources and help you need. There are plenty of food companies still writing their food safety plans, so you are in good company if yours is not yet complete. You have landed in the right place – let ConnectFood help you get it done!

ConnectFood is a great tool to write your food safety plan. You can choose the free option, which is a good place to start, or you can subscribe for a low, reasonable cost. By subscribing, you will have access to the ConnectFood experts, like ConnectFood CEO Matthew Botos, myself, and other ConnectFood experts. If we don’t have the answer, we have a vast network of food safety experts to get you the answers you need.

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

2017 Illinois Food Safety Symposium: A Review

On August 8th and 9th, 2017, the ConnectFood team hosted the 2017 Illinois Food Safety Symposium in Bloomington-Normal, Illinois. There were nearly 250 food industry professionals that attended the two day event. ConnectFood organized and led the Symposium in order to continue the tradition, previously established by the Illinois Department of Public Health of bringing together regulators, academia, and industry professionals in order to work towards continuous improvement of the food safety environment in Illinois.

If you were unable to join us at the Symposium, we hope you enjoy this short overview of what you missed, and that you’ll be interested in attending next year!

The Symposium was started the Keynote address from Mike O’Grady, Vice President of the Bloomington-Normal Economic Development Council, and Molly Lamb, Deputy Director at Illinois Department of Public Health. Both touched on the fact that the food safety industry in Illinois is incredibly strong, but that there are many areas that are being expanded and strengthened. Matthew Botos, CEO of ConnectFood, introduced two of our exhibitors: Cheryl Hodges from Miller & Stryker, and Renee Hoggay from the National Restaurant Association, and encouraged them to speak about their products and businesses.

Matthew Botos, CEO, ConnectFood, welcoming the crowd to the 2017 Illinois Food Safety Symposium.

As participants refilled their coffee mugs and grabbed morning snacks, Dr. Robert Brackett, Director of Institute for Food Safety and Health set up for his discussion of Food Safety Modernization Act (FSMA) & Compliance. He began by introducing the foundation of FSMA – why is it necessary? In the shortest summary possible: FSMA is necessary because food supply is more complex, and an increased percentage of the population is at risk for foodborne illnesses. Dr. Brackett also covered the seven rules of FSMA: Preventive Controls for Human Foods and Animal Foods, Produce Safety, Foreign Supplier Verification Program, Accredited Third Party Certification, Sanitary Transport, and Intentional Adulteration. The first FSMA Compliance dates are right around the corner (this month, in fact): September 17-19th, 2017, so if you need help making sure you’re compliant, now is the time to act.

Dr. Bob Brackett at the 2017 Illinois Food Safety Symposium.

After lunch, Dave Park, Principal, Food Defense, LLC spoke on the topic of Food Defense. He touched base on the history of food defense, food fraud, the intentional adulteration rule, and the comparison of new regulations to HACCP. Mr. Park highlighted food defense audit failures, threats and risks, imports and refusals, and food fraud incidents. “The general Hazard Analysis and Vulnerability Assessment procedure is the same, but the perspectives and expert knowledge bases used are different.” We are told to “Remember: Food Safety + Food Defense = Food Protection.”

Dave Park speaking at the 2017 Illinois Food Safety Symposium.

Next, Matthew Botos moderated a panel regarding Distribution and Transportation of Products, featuring the expertise of Tanesia Cole, Manager of Food Regulatory Compliance at US Foods, and Jeff Newey, Manager of Deseret Transportation. Both members of the panel highlighted their individual company’s background; explaining what they ship, how their shipment process works, and the procedures that are in place to ensure safety in the distribution step. Both touched on the transportation rule of FSMA, urging folks to shift their way of thinking to match the safety regulations of the new rule.

Tanesia Cole & Jeff Newey at the 2017 Illinois Food Safety Symposium.

To close out day one, Matthew Botos, CEO of ConnectFood, and Chris Metz, CTO of ConnectFood, hosted a demonstration of the software. I won’t dive too much into detail here, but if you’re interested in a software demonstration, please contact us & we would be pleased to show you around our website. We wrapped up the day with a short reception, and set our focus on day two.

Matt Botos, CEO, and Chris Metz, CTO, ConnectFood, at the 2017 Illinois Food Safety Symposium.

Day two opened with William Weissinger, District Director at FDA Chicago District, speaking about FDA Inspections & Enforcement Then and Now: Changes Over 5 Years. Ultimately, Weissinger said that the current goal of FDA inspections is to educate while regulating, meaning that the industry shouldn’t attempt to know exactly what to expect during an inspection, as inspections are by special assignment. In addition, it was stressed that all food manufacturers (regardless of size) must be registered with the FDA. (If you need help with that, contact us.)

William Weissinger speaking at the 2017 Illinois Food Safety Symposium.

Jessica McAnelly, Chief, Division of Food, Drugs, and Dairies at Illinois Department of Public Health (IDPH), took over the podium next. She spoke on the state of public health in Illinois, which ended up being a major talking point for a lot of attendees. She spoke about new legislation and updates to the existing legislation. Allergen awareness training is included in these updates – a main change included was that the certified food protection manager must get allergen training within 30 days of employment at a high-risk restaurant. Another major announcement of this presentation was that IDPH will no longer validate hours for Food Service Sanitation Manager Certification (FSSMC) – the Certified Food Protection Manager is a required, national certification.

Jessica McAnelly speaking at the 2017 Illinois Food Safety Symposium.

After lunch, it was Eric Greenberg, Principal Attorney, Eric F. Greenberg, P.C.’s turn to chat with participants about Labeling & Nutrition. The finalized changes for the FDA for Nutrition Facts Label are as follows: calories presented more prominently, an altered format, and added sugars included. Unfortunately, these changes have been postponed indefinitely. In Mr. Greenberg’s words: “One thing’s for sure in the future: Label compliance will always be primarily the responsibility of food companies, and this is especially so given the FDA’s enforcement patterns.”

Eric Greenberg at the 2017 Illinois Food Safety Symposium,

ConnectFood team member Dr. Kathy Knutson moderated our second day panel. (You’ve probably read her outstanding blogs for ConnectFood – if not, check them out here.) This panel included members Joseph Cooper, Emergency Response Coordinator, Chicago District Office, Mancia Walker, Supervisor, Indianapolis Resident Post OHAFO 6E, and Christinae Hudson, Consumer Complaint Coordinator, Chicago District Office. They discussed Recalls & Outbreaks – what they’d seen, effective ways to handle them, and how important recall plans are for the safety of a company. A crowd pleaser that was discussed was the Blue Bell ice cream recall that was enforced across the state of Texas after the delicious ice cream was contaminated with Listeria.

Dr. Kathy Knutson and Matt Botos moderate the Recalls and Outbreaks panel.

The final speaker at the Symposium was Laurie Jahn, Senior Environmental Health Program Specialist of Lake County Health Department, talking about juice production & safety. The objectives of this presentation were to understand the methods of fresh juice processing, determine the code regulations, and present labeling requirements for bottling fresh juice. The main concerns with fresh juice are the possibilities of cross contamination and that there is no kill step, which leaves the juice untreated.

Laurie Jahn speaking at the 2017 Illinois Food Safety Symposium.

Matthew Botos wrapped up the Symposium with a final “thank you!” to everyone that joined us. If you attended the Symposium and have some feedback or need to obtain your certificate of completion, please complete this survey. As always, the ConnectFood team is always available to help you understand food safety. All you need to do is contact us.

Johanna Seidel has been a team member with ConnectFood since July 2016. She holds a B.F.A. from West Texas A&M University. She helped organize and run the 2017 Illinois Food Safety Symposium.

Johanna Seidel, ConnectFood, celebrating the completion of the 2017 Illinois Food Safety Symposium.

How Do I Write a Food Safety Plan?

Congratulations! You are looking for expert help in writing a food safety plan, and you found ConnectFood. ConnectFood developed software for an on-line food safety plan builder with you in mind, every step of the way. You are not alone. Behind the screen there is a cadre of food safety experts to help you. Through our knowledge, experience, and connections, we can help you write your food safety plan quickly. I have known Matthew Botos, CEO of ConnectFood, since 2000. I know Matthew to work tirelessly for the food industry, to travel worldwide for training and helping the food industry, and to network with government agencies from local to federal.

FDA recently published their on-line food safety plan builder for food manufacturers. Like usual, FDA is late to the party and behind industry. I have worked alongside some fine people at FDA. They work hard to steer a huge, government system. Like the Titanic, reaction time is slow and often too late.

ConnectFood has been working with the food industry to write food safety plans for over three years. My biggest concern for companies writing their food safety plans is getting their questions answered in a timely fashion. FDA has a Technical Assistance Network (TAN) which will answer questions on the rule only. Don’t expect an answer within 24 hours. At FDA pace, it would take months to write a single food safety plan. If the question is outside the realm of the rule, companies will be referred to the Food Safety Preventive Controls Alliance (FSPCA) TAN. Matthew, ConnectFood Experts, and I have access to members of the FSPCA TAN too.

Getting questions answered is one of the reasons that a Preventive Controls Qualified Individual (PCQI) is required to supervise the writing of a food safety plan. Do you know who is a PCQI? Matthew Botos, CEO of ConnectFood, and I are. Not only are we PCQIs, but we are also Lead Instructors of the workshop for PCQIs. Matt Botos also is a Trainer of Trainers. Collectively, we have delivered over 50 PCQI workshops since the end of 2015. It is pretty safe to say we know the rule. Matthew is a food engineer, and I am a food microbiologist. Along with our network of food safety experts, ConnectFood has you covered. The ConnectFood software is a cost-effective method to get your food safety plan written. ConnectFood continues to develop cutting-edge easy-to-use software for an on-line food safety plan builder that can be used to showcase food safety either on-line or printed out to be shared with clients or regulators.

ConnectFood is not just for food manufacturing. Restaurants are using the ConnectFood software to build their Hazard Analysis and Critical Control Points (HACCP) plan. While the application is a bit different, the process of building a HACCP plan is the same. ConnectFood is the perfect solution for chefs and our foodservice friends: restaurant food safety could look like HACCP, the important part is to know your product, ask yourself if you have any hazards, and have a good safety plan!.

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


Recalls: Lessons Learned

In the last year, I have worked side-by-side with industry folks as they navigate the aftermath of a recall. Every recall is unique and presents its own unique challenges, but here are some lessons I learned and can share with you. That is, most of this experience remains confidential.

Are you sure you must initiate a recall?
As a food microbiologist with expertise in lab methods, you need someone on board who understands the testing methods. You can find this expertise with your contract lab or with a consultant, if you don’t have it in-house. If you are initiating a recall due to a pathogen, you need to understand that these tests are comprised of many steps, and therefore days, before a positive pathogen test is confirmed. If that concept is foreign to you, find your person who is going to ask what method was performed and what was the result at every step. Where was the test performed and by whom? Labs make mistakes! Be absolutely certain that the positive pathogen result is true before initiating a recall. I have a story about this that is so bad, I can’t even put it in writing. Warning: be very certain.

Get yourself a good lawyer.
My cousin Vinny is not qualified to be your recall lawyer. Most companies use an outside lawyer or firm for business dealings on a routine basis. Your company attorney may be a relative or friend. This is not the person to work with you in a recall. The lawyer must have experience communicating with FDA. I have heard stories of lawyers thinking they are going to strong arm the FDA, they tell off the FDA, and the food facility just gets greater scrutiny and ends up doing even more work for the FDA. There are lawyers and firms who specialize entirely in working with the food industry and its government agencies. Hire a great recall lawyer. It is going to cost you a lot of money. Recalls cost a lot of money. If you want to fix the problem and resume operations, hire a great food recall lawyer.

Don’t move that product!
After a recall has been initiated with the codes of the recalled product, you probably will have product on site. It will be in the way. You will want to move it out of the way and into long-term storage. Don’t move that product, unless you have written permission from your state or federal recall coordinator. From my experience with product contaminated with a pathogen, that product is now considered hazardous material and must be handled as hazardous material. First, that means you must protect your workers, so that they do not become contaminated. The recall coordinator will want to know how much product was produced, where it went, and how much is under your control on-site or in company-owned warehousing. Once you have that information, you may present a plan for storage and moving the product into storage. To move the product during a recall looks nefarious, and you do not need any extra headaches during the recall.

Unfortunately, food recalls are an every-day occurrence and no company is exempt from the possibility. As much as possible, be prepared. If you are in a recall, be smart. I hope you can learn from these lessons.

The search for forms and checklists can be overwhelming. The ConnectFood website has free resources. After you sign in for free, you will have access to forms and checklists. The folks at ConnectFood are here to help! Contact us.

For more about recall plans, read part two of this blog.

Dr. Kathy Knutson 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


FDA and the State of Wisconsin Agree to Recognize Each Other’s Inspections

At the Food Safety Summit 2017 I heard an announcement that piqued my interest. The FDA and my home state of Wisconsin have an agreement for recognizing the other’s inspections. There will not be duplicate inspections! That is great news. Wisconsin Department of Agriculture, Trade and Consumer Protection (WDATCP) and the FDA Minneapolis District Office (MN‐ DO) have developed a process for sharing inspection reports, work plans and establishment inventories; read more about that agreement here.

First, I want to state the obvious. That’s the way it should be. I feel for the food companies that have more audits and inspections than there are months in the year. Inspections are time-consuming and costly to business. Food prices include the cost of audits and inspections.

This was a big announcement at one of the keynote presentations in front of a packed room. It was big, because that is not what is normally done. Even though the state and FDA inspectors use the same federal rules and have the same goals, they rarely coordinate inspections, resulting in duplicity.

The other reason this agreement makes sense is that both FDA inspectors and state inspectors are going through the same training on the FSMA rules. Matt Botos, ConnectFood CEO, and I know, because we trained them. For the last year I have had state of Wisconsin inspectors in my Wisconsin workshops and FDA inspectors in workshops across the nation. Everyone feels better knowing that FDA inspectors, state inspectors and industry are all in the room for training together. I have only had good experiences with exchange of information. I did not get a sense in the classroom that industry was shy about asking questions, which one might fear. Inspectors were honest about where they were in the process of learning and enforcing the Preventive Controls for Human Food (PCHF) rule. As I have attended training, listened and read about the roll out of other FSMA rules, I have heard over and over that FDA plans to train inspectors with industry, following the training model of the PCHF training. That is more good news.

At Food Safety Summit 2017 I confirmed that FDA is conducting 300 PCHF inspections for fiscal year 2016-2017, the year ending in September. These will be at businesses with more than 500 employees. Other inspections beyond the 300 will be GMP inspections and are designed to educate on PCHF. The food industry can relax (a bit) in the knowledge that the FDA is getting trained alongside industry and will use inspections as an opportunity to educate on FSMA.

Dr. Kathy Knutson 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

What is FDA Going to Look for When They Swab?

Swab samples taken by the Food and Drug Administration (FDA) are intended to find pathogens, if present: Salmonella, Listeria monocytogenes, or pathogenic Escherichia coli. These are three pathogens to put fear in the strongest food safety professional. I recently left a food facility where we discussed all three. If Salmonella is the old, and L. monocytogenes is the current, then pathogenic E. coli is the future.

Every Salmonella is pathogenic. Some Salmonella are associated with their source, like turtles and chickens. The majority of foodborne illness is caused by just ten out of thousands of serovars of Salmonella. When we come across a Salmonella that is not among the top ten, we take note. That was the case with the Valley Milk recall. Salmonella meleagridis was identified. This one is rare. What does that mean? It means it was unique to the product and environment. Since it is unique, it may be able to be traced to a source. All Salmonella patient isolates are tested by whole genome sequencing (WGS) and are in the PulseNet database. If there are any patient isolates of Salmonella meleagridis, the Centers for Disease Control and Prevention (CDC) will investigate the link between the patient and consumption of food with the contaminated milk product.

What is an isolate? In a sample of patient fecal matter, finished product, raw ingredient, or environmental swab there is a variety of microorganisms, mostly harmless. When the lab pulls out the pathogen from among millions of other cells, the pathogen is grown as a pure culture. This is the isolate. This is also why microbiological testing takes time. Our lab tests are designed to find one pathogenic cell among millions of harmless cells.

Salmonella is big deal. An estimated one million cases of salmonellosis occur every year in the United States. Where will FDA test your facility for Salmonella? FDA will sample dry ingredient storage, dry blending, and “dry” operations. Roasting and grinding of nuts are dry operations. Nut butters and oil-based products are made in a dry area, i.e. where there is no use of water. The facility I just left was a wet operation, except for one product where they had a dry seasoning. When FDA swabs, they could test that one area for Salmonella. For the most part, FDA is not currently focused on Salmonella. The exception to that is manufacturers of products in an industry where there have been recalls, like peanut butter.

Keep your ears open for recalls by your competitor. You can sign up for recall alerts.

Listeria is the current favorite of the FDA and CDC. For example, there was an FDA initiative to visit raw milk cheese plants for swabbing. Other foods are not immune. FDA is going to facilities and conducting intensive swabbing. When the FDA arrives with a handful of inspectors, over 100 environmental sites will be swabbed from zones 1, 2, 3 and 4 per day. Product samples will be taken. My advice is to hold all product made on those days until Listeria tests are negative. Negative results should be reported within days. If Listeria tests are presumptive, consider discarding the product. However, be prepared to wait weeks for FDA to communicate results. What do you do if you can’t hold your product? Discard it. Limit the runs on the days the FDA is swabbing. Document the disposition of the product, in case the results come back positive. Companies have decided to simply discard perishable finished product made during these inspections, rather than wait for results.

Why wait for the FDA to show up for swabbing? My advice is to conduct your own intensive swabbing exercise. Know the areas of your facility that are hot for Listeria. Do you have to test product? No. Do you have to test zone 1 for Listeria? No. For zone 1 food contact surfaces, I recommend Enterobacteriaceae counts. You could do coliform or E. coli testing instead of Enterobacteriaceae. Do you have to test for Listeria monocytogenes? No. You can test for Listeria genus. Of the 17 species of Listeria, only L. monocytogenes is pathogenic. Getting a positive Listeria genus test means the environment is conducive for L. monocytogenes.

There is a difference between Listeria genus and Listeria monocytogenes testing. First, you will get the Listeria genus results quicker. Second and if you stop testing at Listeria genus, you will not have direct documentation of the presence of L. monocytogenes, the pathogen. The key is in your corrective action. Your corrective action might be the same whether the test is a presumptive Listeria genus test or a positive L. monocytogenes test. In other words, treat the seriousness of a presumptive Listeria genus the same as a positive L. monocytogenes.

The FDA published the draft Listeria guidance in January 2017. The guidance is currently in its comment period. All draft guidance represents the FDA’s current thinking on a topic. While not mandated, FDA expects industry to conduct environmental monitoring for Listeria when ready-to-eat (RTE) foods are manufactured. There is even greater FDA scrutiny for RTE foods which can support the growth of Listeria. We are anticipating another FDA guidance document to further define RTE foods. In the meantime, refer to the Preventive Controls Hazard Guide; it is 185 pages. There are categories of food, their hazards, and examples of food in the category. This is FDA’s current thinking on hazards in food. If the food is categorized as RTE, the facility should have a Listeria environmental monitoring program.

Do you need help in designing your environmental monitoring program? I would love to help!

Every isolate of L. monocytogenes from a patient has been sequenced by WGS and is in the PulseNet database. This fact keeps food safety professionals up at night. The FDA can pull a food from the grocery shelf, isolate L. monocytogenes, inform the company to initiate a recall, and match the food isolate to a patient isolate. Check out my previous post, What I want all my students to know about Listeria.

Most E. coli are not pathogenic. We can test on-site at a food facility for Enterobacteriaceae, coliforms, or E. coli and not be in fear of growing billions of cells of pathogenic E. coli. For now, what you need to know is that patient isolates of pathogenic E. coli will be sequenced by WGS and be in the PulseNet database. In the same way that Salmonella or L. monocytogenes can be matched from food isolate to patient isolate, so will pathogenic E. coli be matched. The technology and laboratory expertise are there.

It is somewhat comforting to know that that while the number of recalls is increasing, the number of cases, i.e. patients, is decreasing. The food industry is making great strides in food safety. Because of greater surveillance and communication, the average number of cases (patients) per outbreak has decreased. The number of multi-state outbreaks has increased for the same reasons.

There is much to be hopeful about around food safety. Job security is one!

Dr. Kathy Knutson 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