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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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Examine Your Facility During a Hard Rain

If you are in a drought, just have me visit, because I seem to bring rain storms. At first, I was frustrated by rain and having to navigate to a facility new to me. But when touring food plants after or during a rain storm, it is a blessing. Now I pray for rain! Examine Your Facility During a Hard Rain was a slide title in a presentation by Kevin Lorcheim of ClorDiSys Solutions, Inc., during the workshop Key Elements of a Food Safety System. Hearing Kevin talk, plus there was an 80% chance of rain that afternoon, got me thinking about my visits to food plants.

The next time you get a hard rain, I encourage you to walk your entire facility and perimeter outside. When inside, you are going to look up at the ceilings. Search for any evidence of water getting in and dripping down. Are the ceiling tiles bowed and holding water? Do you see evidence of water from stained ceiling tiles or hanging light covers? Are tile tracks rusted? Pay particular attention to pipes and I-beams coming down from the ceiling and any water coming down.

The next level down is the dripping lines. In most facilities and when it rains, there will be excessive condensate dripping down from cold lines. Pay extra attention to areas over the open product, in packaging, in dry ingredient and packaging storage and in final product storage. While you are looking for condensate drips, look for leaking pipes. I am a professional leak detector. Product, steam or water. This is a point of high complacency in food plants, where employees get numb to leaks and don’t report them for repair. You do not need to pay a consultant to detect leaks. Repairing leaky pipes is critical for efficient operations.

I was in a plant one morning where liquid product was shooting from a pipe. The pinhole leak had been reported before midnight, and the split had grown. This was a 24/7 operation. Product was literally going down the drain. The QA Manager reported the leak; the pipe was repaired and reinstalled. Not long after, the pipe had split again and farther, so product was showering out. The QA Manager reported the leak again. Please train all employees on the importance of reporting leaks.

You are probably not standing at shipping or receiving as you read this, but when you get a hard rain, investigate those sites. When a driving rain hits the side of your building, does water ingress around bay doors and outside doors? As part of your facility walk, examine doors and outer walls as soon as possible after the rain to detect leaks. Look for rivers flowing from bay doors and wet floors under the doors. Many food plants have screened windows and other air intakes; check these too. Does the rain flow down an inside wall from an upper window?

As you walk your facility, has a new river of water formed on the floor? There may be a leak coming down along an I-beam or into an interior wall and then out. The good thing about water is that it follows the path of least resistance. When you start at the river on the floor, follow the path to the wall or interior structure, and trace back to the source.

Examine EVERY room from top to bottom in your facility: boiler room, maintenance, break room, dry storage, cooler, offices, shipping and receiving. Talk to your people and ask them where they see water. Do not skip any area. Be deliberative about seeing every room. It would be best to check the outside of the building during the rain storm. Walk the perimeter outside. Note standing water. Check the integrity of the building to keep water out. Check the that downspouts are functional.

By fixing your problems of water coming in, you will stop or prevent problems in your food plant. Still have questions? 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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4 Signs of a Food Safety Culture

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

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How do I Add Radiological Hazards into My Food Safety Plan?

Radiological hazards are chemical hazards.
Radioactive chemicals emit harmful radiation that at large doses is harmful soon after exposure and at small doses is harmful years or decades later. Our food may become contaminated through the absorption of radioactive chemicals found in soil or water. Radioactive chemicals in air may settle onto food, water, or soil. Terms used to describe radioactive chemicals include: radioactive isotopes, radioactive elements, and radionuclides. Examples include: radioactive cesium, uranium, and strontium.

You may be familiar with radon testing before purchase of a home; this is standard practice in real estate. I was at the house we were purchasing when the radon test was done – it was a beautiful day, but I could not open the windows or the test would be invalid. Radon is a gas. When a radon test is done inside a house, the air is tested for a given time. (Our house passed the radon test.) Radon is not a chemical hazard of major concern in the food industry.

Radioactive chemicals are naturally present in some rock formations. As rainwater filters through soil and is collected in aquifers below the surface, the water may pick up radioactive chemicals. If your facility uses well water, research the location of the aquifer. What is known about the soil and rock formation surrounding the aquifer? Is the location known to have a risk of radioactive chemicals? If your facility uses municipal water, your water treatment facility tests for radioactive chemicals. Add your annual water report from your water treatment facility to your food safety plan. If you have questions on the report, talk with your local water treatment facility.

When you write your hazard analysis, include radiological hazard as a chemical hazard once for your water supply.
In the hazard analysis you may determine that the hazard does not require a preventive control and will remain as a Good Manufacturing Practice for potable water.

Approve suppliers using your own criteria.
If ingredients for your product include a crop, you may have concerns about the location of the field and water used for irrigation. Theoretically, there could be an uptake of radioactive chemicals if present in the soil or if present in the water used for irrigation. Know the location for the crop and communicate with your supplier if you have any concerns.

Radioactive chemicals are of concern after nuclear power plant accidents. In the 1986 Chernobyl nuclear power plant accident in what is now the Ukraine, plumes of radioactive material were sent into the air in updrafts from a steam explosion and resulting fire. The radioactive material settled into the surrounding area as the wind blew away from the facility. In the 2011 Fukushima nuclear power plant accident in Japan, a tsunami hit the coast. Loss of electricity to cooling pumps caused a reactor meltdown, explosions, and release of radioactive material to the air, ground water, and the Pacific Ocean.

What can you do about the potential for a nuclear power plant accident near you? First, locate the nearest nuclear power plant to your facility. The website for the Nuclear Regulatory Commission has a feature for locating nuclear power plants. Second, determine if you are within an emergency planning zone and review the plume exposure pathway. If your facility is within 50 miles of a nuclear power plant and an accident occurs, there is a ban of contaminated water and food.

When you write your hazard analysis, include radiological hazard as a chemical hazard for your location.
If your facility is within 50 miles of a nuclear power plant, identify a hazard requiring a preventive control and write an emergency plan. Being prepared for an emergency is the best insurance that it won’t happen.

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.

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First Cold Brew Coffee Recall

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.

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Hurricane Sandy and Food Trucks: The Wisdom of “Form Ever Follows Function”

As Louis Sullivan, a Chicago guy of the early 20th Century, could have warned us about the food and fuel issues of Sandy’s aftermath: “Form Ever Follows Function.”

Crisis has a way of focusing things down to the essential. In the case of the folks dealing with Sandy, the form of basics like food follows our functions—grocery stores (without food), gas stations (running out of gas), big electrical distortion systems (without wires to deliver power to homes or hospitals), and big public transportation systems (without tracks that can be energize). However, it could be different. We could scale the form of delivery of production of food to function better, given that it appears likely it will have to work in a period of profound climate extremes of simultaneous drought and flood.

On the food side what a difference a fleet of local food trucks with hot meals could make. In fact if you read this story, local food trucks are making a difference by using Twitter to coordinate delivery of hot food to Sandy victims: Food Trucks Heed Call Post Sandy

Of course, it’s not just about food trucks; it’s also about Urban Ag as a tool for helping in crisis. In the case of food, I’m fairly sure people who can’t get to the grocery store (and might not find food if they could) would welcome an urban chicken with an egg or an urban farmstead with a tilapia or a tomato. They’d probably appreciate it even more if they could walk or bike to such a place.

The form we deliver food in has to follow the essential function of feeding people by sustaining the food and ag system in a time of profound climate change. If the food or ag system collapses, then it’s kind of game over.

At least for this week, a low cost food truck with a hot meal down the block beats a global food chain that can’t deliver to a grocery store that couldn’t open without electricity.

The lesson we learned from Katrina was FEMA took days to deliver water, whereas Wal-Mart had trucks ready to move as soon as they could safely travel. So if you wanted drinking water, your chances were better in the Wal-Mart parking lot than the federal government site. And, the lesson from Sandy might be if you want a hot meal, be sure you can tweet a food truck near you.

Maybe we should do this in Illinois before it’s our turn.