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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 https://www.linkedin.com/in/kathyknutsonphd.

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 https://www.linkedin.com/in/kathyknutsonphd.

Cyber Security; the Threat is Real but Manageable

I got my socks scared off me. It is really not surprising, because I was at a Food Defense workshop, by the way at my alma mater, the University of Minnesota. The day started out predictably and smoothly. In the afternoon things turned dark, when John Hoffman of the Food Protection and Defense Institute spoke about the challenge of cyber security in the food industry.

If you work in the food industry, think of every device you have that is connected to your company network and then every access point to the internet. There are hackers out there who can get in to your data, and they will, if you do not actively monitor and stop them. If you work for a large corporation, there is a hacker out there right now trying to get in to your system. The hacker may be hired by your competitor or a foreign government. They are not phishing; it is targeted hacking. Scared yet?

Let’s think about our devices. At every step from Receiving to Shipping there are electronic devices to document data and store information. Think of supplier information, warehousing records, lab data, batching, packaging codes. Can you access that data from anywhere on the network? Can you monitor data from home? If you can get on the network, so can a hacker. If I have your email address, can I guess the email address of the President or CEO? I actually did that once. It was easy. A colleague of mine had a new job, and I didn’t have his new email address yet. I looked on the website of the company to find email addresses of others and guessed his email. Easy.

Where do you have a security camera? Is the recording separate, so that no one can hack in? I don’t normally watch spy movies, but I have seen by-passing of security cameras in enough movies to know it is not a unique concept. One of my favorite movies, National Treasure, uses the override of a security camera to steal the Declaration of Independence.

Where is the electronic image stored? Who has access to not only the folder but the network where it is stored? Really think through how security cameras are used for recording images, monitoring of the data, storage of the data, and how are you going to be certain it is not hacked. You must have continuous monitoring for intrusion of the data.

Luckily, my colleague at ConnectFood, Chris Metz, ConnectFood’s CTO, had recently warned me to remain diligent on using a unique password for every account and using systems like LastPass to manage it. Also, one of the biggest mistakes companies make is the misconception that just because their files and trade secrets are on their local drives, they are safer than in cloud storage because they seem more tangible. This is unfortunately not true as many companies do not properly invest in proper encryption and firewalls to keep hackers or ‘backdoor’ viruses from accessing their files and are not able to detect an intrusion since they don’t have monitoring in place. Even though hacks of larger storage providers make the news in a more sensational way, the hacks of smaller systems of everyday companies happen far more frequently and rarely if ever get reported. Using 3rd party cloud storage providers for the majority of companies is still by far the best option to protect their data because of the large investments made by those providers in several tiers of security and intrusion detection. Armed with this mindset, I came to the food defense/Intentional Adulteration (IA) workshop in Minneapolis.

Matt Botos, ConnectFood CEO, developed a food defense program after 911 while Director of the Illinois Center for Food Safety and Technology. There was no government mandate then- just the need to protect the food supply. Now we have FSMA. The Intentional Adulteration rule is the seventh rule under FSMA to be enforced. Luckily, industry has time as enforcement dates start to roll out in 2019. Then, FDA intends to tack on an Intentional Adulteration inspection quick-check to a food safety plan audit and inspection. It will be years after 2019 and with appropriate funding before full Intentional Adulteration inspections will be done.

Watch this blog for more information. And as always, contact the folks at ConnectFood with your questions and food defense issues.

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 https://www.linkedin.com/in/kathyknutsonphd.

Risk-based Preventive Controls

If you are new to the food manufacturing industry or at least new to food safety, you may not know that the food industry heavily relied on finished product testing to determine safety. It wasn’t until the US manned space program was developed in the 1960s that industry looked at building safety in to the process. Now we look more at farm-to-fork and identify preventive controls outside of processing, as well as within processing. Because of this all-inclusive trip down the food highway, some managers have a difficult time choosing the controls most important to food safety.

One analogy I use is my frightening drive from Green Bay to Chicago one January. I worked until 6:30 pm and left Green Bay in the dark. As I drove out of Green Bay and into the darker countryside, it started to rain. The rain mixed with buckets of snow that alternated between rain and snow for the first hour of my drive. I was in a hurry, driving fast, and actually hydroplaned at least once. As fast as I was going, I was still being passed by semis and other trucks. By the time I reached Milwaukee, the rubber of the driver’s side wiper was flapping around and giving me a marginal view.

In this scenario, what were the most important controls for a safe drive? I stopped in Milwaukee to install a new wiper. My tire tread kept me on the road. The lights were working, as was the engine. I used my seatbelt. The air bags were assumed to be in working condition. The brakes worked. The gasoline is analogous to utilities. My cell phone was charged, if needed as a communication tool.

It was not important how much trunk space I had for my bags. It was not important that the radio worked. Optional features like automatic windows or adjustable mirrors were not important.

Similarly, much of your process is not related to safety. In the hazard analysis for our food safety plans, we are asked to identify hazards and their preventive controls. When you are deciding if a preventive control is needed, imagine taking it away. In my driving scenario, my safety would be compromised without working wipers, lights, tires, engine, seatbelt, air bags, and brakes. These parts of driving received my utmost focus that night. What, if taken away, will compromise safety?

I cannot take credit for the following analogy to define risk vs. severity, but it is a good one. When we are out walking in the world, there is a risk of getting hit and hurt by a car. It is a hazard we all experience. When I leave a building and walk through the parking lot to my car, the probability or severity of getting hit and hurt is small. It hasn’t happened yet! If I do get bumped by car, my injuries might not even be treatable. Now let’s say I walk across an LA highway-six lanes going each way. The risk of getting hit is high, and the injuries will be severe. Think about it; it is the same hazard!

Since I scored high in Harmony on the StrengthsFinder survey, I like my team to be happy and get along. If you have food safety teammates who want to list every hazard in the world in your hazard analysis, keep the peace, and go ahead and list them! Then, your team will debate the risk vs. the severity. By the way, at the end of Chapter 1 in the book for Preventive Controls for Human Food, there is a nice definition for your team of both risk and severity. If loss of control results in a class I recall due to an allergen or pathogen, then the hazard is automatically severe and must have a preventive control. Other hazards, while theoretically possible, may be concluded to be of low risk and low severity. These hazards to not require a preventive control.

As a team:

  • Identify hazards.
  • Define risk vs. severity.
  • Debate and assign risk and severity to each hazard.
  • Identify hazards requiring a preventive control.

The folks at ConnectFood are here to walk across the farm-to-fork path together, hand-in-hand.

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 https://www.linkedin.com/in/kathyknutsonphd.

Good Manufacturing Practices (GMPs)

When I am teaching the Preventive Controls for Human Food workshop, I am often asked about Good Manufacturing Practices (GMPs). Do we still have to follow GMPs? Yes! GMPs are the foundation of a food safety system. Without GMPs or by not following GMPs, food safety cannot be achieved.

Basics done well have not changed!

A successful GMPs program requires buy in from management and commitment. In the food industry, we have seen the mindset of management change from the Quality department being a cost center to the Quality department being a necessary business expense. Quality departments have grown in personnel and budgets.

A successful GMPs program includes prerequisite programs. Some of these programs support the work you do at your facility and some of them overlap with GMPs. Prerequisite programs are procedures for the handling of ingredients and packaging from receiving to finished product at shipping, and everything in between, all with the goal of food safety. For example, your company may have a procedure for hiring and training new personnel. Prerequisite programs work hand-in-hand with GMPs and are a part of every successful company.

Let’s review where to find GMPs. GMPs have been around for ages in the food law in Part 111. Now, you will find GMPs in the FSMA rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. GMPs are a section in the Human Food rule, 21 CFR 117. In Title 21 of the Code of Federal Regulations (CFR), you will find all the rules enforced by the Food and Drug Administration; this rule is Part 117. In Part 117, there are seven sections called subparts:

Subpart A – General Provisions
Subpart B – Current Good Manufacturing Practice
Subpart C – Hazard Analysis and Risk-based Preventive Controls
Subpart D – Modified Requirements
Subpart E – Withdrawal of a Qualified Facility Exemption
Subpart F – Requirements Applying to Records That Must be Established and Maintained
Subpart G – Supply-chain Program

The FDA has dedicated one of seven subparts in the Human Food rule to GMPs; Subpart B is a big deal. Notice how GMPs are before Subpart C, which requires a facility to conduct a hazard analysis. The result of the hazard analysis is to identify hazards and then create preventive controls for each hazard. Even if a facility identifies no hazard or maybe one hazard requiring a preventive control, it doesn’t change the fact that you still need GMPs.

Even if you do not find a hazard, you still need GMPs.

The challenge in the food industry is to meet the GMPs requirement. Every facility is unique and will approach GMPs in diverse ways. The crucial step is to address GMPs to create a food manufacturing environment that results in safe food. Here is an outline of Subpart B (remember 117 means 21 CFR Part 117):

§117.10 Personnel
§117.20 Plant and grounds
§117.35 Sanitary operations
§117.37 Sanitary facilities and controls
§117.40 Equipment and utensils
§117.80 Processes and controls
§117.93 Warehousing and distribution
§117.95 Holding and distribution of human food by-products for use as animal food
§117.110 Defect action levels

Each facility must create programs to address the GMPs. Programs include training of personnel in food safety, sanitation procedures, and a pest control program. For optimal application, each program should have a written standard operating procedure (SOP) and means for record keeping. This includes sanitation SOPs or SSOPs. We say, “if it is not documented, it didn’t happen.” Inspectors and auditors will ask to see your documentation of GMPs.

The search for GMPs forms and checklists can be overwhelming. The ConnectFood website has the resources you need. After you sign in for free, you will find information under cGMPs. Do you have questions about GMPs? The folks at ConnectFood are here to help! Contact us.

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 https://www.linkedin.com/in/kathyknutsonphd.