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What I Learned from an FDA Seafood Guidance

I was on a flight to Boston, and in my hand was the FDA draft guidance, Seafood HACCP and the FDA Food Safety Modernization Act: Guidance for Industry. HACCP is hazard analysis and critical control points, and the Seafood HACCP rule was published in 1995. I had received the FDA guidance document at the previous Preventive Controls for Human Food (PCHF) workshop that I taught in Seattle. In Seattle, I had several workshop participants who worked in the seafood industry. I had dined on delicious salmon in Seattle and was dreaming of eating fresh seafood in Boston.

A substantial difference between the Seattle workshop and the Boston workshop was that the Boston workshop was comprised of people from the milling and baking industry, not seafood. Darn. Seafood HACCP has a life of its own in regulation, and I was looking forward to learning more about seafood from the workshop participants. Reading the guidance would not further my expertise as a Lead Instructor for the Boston workshop, but nevertheless I was in the mood to read this compact document. As I skimmed the introductory material, I came to a nice question and answer (Q & A) format. The FDA always does a nice job of communicating important information through the format of Q & A. Sometimes it is just nice to see plain English from the FDA, and that’s what a Q & A provides.

I did learn some information specific to the seafood industry from the guidance document, but it was the general information from the Food Safety Modernization Act (FSMA) that piqued my interest. Do you know the following three facts?

    1. Training and training records are now required.
    FDA is making a big deal out of training. Every person employed in the manufacturing, processing, packing or holding of food must be trained in food safety. There must be training records kept for each individual showing the individual is a “qualified individual” to perform his or her job. Supervisors must have additional training to demonstrate they are qualified to do their job.

    Who organizes the training records at your facility? The inspector will ask to see training records of employees. The more organized your company is, the easier it will be to show these records to the inspector. Training records can be paper, electronic, or a combination. FDA is focusing on training, so be prepared.

    2. Written sanitation procedures are not required for GMPs.
    Subpart B of the PCHF rule is Good Manufacturing Practices (GMPs) and replaces GMPs found in 21 CFR 110. Subpart B does not require written sanitation procedures. This means that the chemical concentrations, equipment, times and temperatures for a cleaning or sanitizing procedure are not required to be written, but you should. See my previous blog post on Sanitation Standard Operating Procedures (SSOPs).

    The sanitation crew at most facilities has a lot of turnover and little supervision for an extremely important job. Writing the procedures will facilitate training, consistency and effectiveness of cleaning and sanitizing. Written monitoring procedures and corrective action records are required.

    3. Written sanitation procedures are required for sanitation preventive controls.
    In Subpart C of the PCHF rule, this is how the logic flows in the rule:

    1. A written food safety plan is required 21 CFR 117.126(a)(1).
    2. A food safety plan includes preventive controls 21 CFR 117.126(b)(2).
    3. Preventive controls must be written 21 CFR 117.135(b).
    4. Sanitation preventive controls are procedures, practices and processes 21 CFR 117.135(3).

Therefore, if a facility identifies a sanitation preventive control in the hazard analysis, written sanitation procedures are required.

If a facility has an allergen in one product, but not in another product from the same line, the facility will have a sanitation preventive control for the allergen clean procedure. If a facility produces a ready-to-eat product, the facility will have a sanitation preventive control for the cleaning and sanitizing procedure to control pathogens. Like Subpart B, written monitoring procedures and corrective action records are required.

Even with plain English, information can be confusing. When I am teaching the PCHF course, I warn the participants that the answer to a question may be, “You have to take that to legal.” I encourage you to visit the FSMA website and review FDA guidance documents. Boston was my 17th PCHF workshop, and I am still learning.

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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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 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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What Happens at Receiving Does Not Stay at Receiving

Receiving is a critical operation within your company with great responsibilities.

  1. Receiving of raw materials potentially contaminated with pathogens
  2. Receiving of ingredients with known allergens
  3. Receiving of ingredients or packaging with a supply chain preventive control
  4. Prevention of intentional adulteration

Receiving personnel need access to records at Receiving. Do Receiving personnel have a tablet or computer to look up approved suppliers, specifications and other information? Stickers and placards should be readily available to label totes or pallets with QA hold, allergen, or other warnings. Receiving personnel must be properly trained in the receipt, labeling and handling of raw materials potentially contaminated with pathogens, ingredients with allergens, and ingredients or packaging with a supply chain preventive control.

Written procedures are required for Receiving for ingredients with a supply chain preventive control.

The Preventive Controls for Human Food rule Subpart G details the requirements for supply chain preventive controls. With every receipt of an ingredient with a supply chain preventive control, bill of lading should be checked, along with the receipt of documentation of the absence of the hazard. The latter is needed, regardless of the same lot being repeated.

Receiving should have written SOPs for the inspection of vehicles for sanitary transport and receipt of materials in intact totes or on intact pallets. Not only are you concerned about determining if pests have accessed the ingredient, you are also preventing cross-contamination of pathogens and cross-contact of allergens. Within the written SOP, address the refusal of goods where the truck is unsanitary or when the packaging is compromised.

The Intentional Adulteration rule is effective in 2019, and Receiving plays a more direct role. Many of the steps taken now, like sealing of gaskets, will be documented to comply with the rule. The focus of the rule is on liquid ingredients and ingredients with the potential to cause widespread harm to public health. As you are implementing your food safety plans, consider incorporating measures designed to prevent intentional adulteration at Receiving.

Once an ingredient is accepted and properly labeled, Receiving may be responsible for notifying QA of a QA hold or for proper moving of ingredients to storage. Proper handling does not compromise the ingredient through cross-contamination or cross-contact. Another part of the Intentional Adulteration rule addresses the disgruntled employee. Start at Receiving and walk through the potential for an employee to have access to an ingredient or process, with the intent of widespread harm.

Receiving personnel play a key role in the safety of food. By providing the training and resources necessary for them to do their job well, you create a culture of food safety from the beginning.

Paperwork! Paperwork! And more paperwork! 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.

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

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 ConnectFood.com 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. https://www.linkedin.com/in/johanna-seidel-3a98b6130/

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

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If I Am Compliant with a Third-Party Audit, Am I FSMA-Compliant?

One of the biggest challenges for a company and its Preventive Controls Qualified Individual (PCQI) is organizing both the food safety plan and materials for an audit. The food safety plan will be reviewed by the local, state, or FDA inspector. Some companies are under USDA inspection as well. In my experience, most food companies have a third-party audit for BRC, SQF, or ISO 22000 certification or with an auditing firm specializing in food manufacturing. How do you prepare for both?

There are different requirements for a government inspection and a third-party audit. The inspection is driven by public health and regulations. Food facilities will be inspected against the requirements for Good Manufacturing Practices, hazard analysis, preventive controls, and recall plan found in the Preventive Controls for Human Food rule. Quite frankly, the government is not concerned at all with your audit criteria. The focus will be on public health and FSMA rules. Going forward, FDA inspections will evolve in to more audit-like activities with the emphasis on record review. The PCQI is required to organize or oversee the organization of records. The goal is to be inspection-ready at all times.

Much of the material that is required for an audit is the same for an inspection. Each certification or auditing body has their own requirements, and often the PCQI has the responsibility of organizing these materials also. Do you need help with organization? I encourage PCQIs whom I train to find that one person at work who loves office supplies. Put them in charge of labeling and storing materials. Trust me, they will love it! Also, find the person who is exceptionally good at organizing electronic documents. Put them in charge of developing the system of storage and retrieval. The PCQI just needs to know where paper and electronic files are and how to access them.

Do you remember Venn diagrams? List everything you need for an inspection in one circle. List everything you need for an audit in a second circle. What overlaps, and what is unique? One option is duplicating common records for both inspection and for auditing. Another option is to keep records unique to an inspection separate from records unique to an audit and have one record of common records. The inspector will not review records unique to an audit. As you are working through this organization, focus on the best location for individual records, in general. Records for an inspection can be paper or electronic, in a format of your choice. There is no mandate for use of forms. Focus on what makes sense for storage and then retrieval of records.

Let’s go back to the original question. If I am compliant with a third-party audit, am I FSMA-compliant? Maybe; it depends. The Preventive Controls for Human Food rule requires a written hazards analysis which identifies hazards requiring a preventive control. The preventive controls go beyond process preventive controls to include allergen, sanitation, and supply chain preventive controls. If all the preventive controls are addressed in the audit requirements, then you are covered for both an inspection and audit. Beyond the Human Food rule, are you compliant with the Sanitary Transportation rule? In 2019, compliance with the Intentional Adulteration rule takes effect. Are you required to comply with any of the other FSMA rules? The answer is complicated.

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.

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

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Food Allergens: Eight Key Points

I have been teaching for over a year from the Preventive Controls for Human Food curriculum and feel quite comfortable with the topic of food allergens. I heard a talk by Dr. Steve Taylor, Co-Director and Founder of the Food Allergy Research and Resource Program. These are eight key points I learned.

  1. The science of food allergens is new. Food allergens were recognized in 1988. An article in the Journal of the American Medical Association from a physician at the Mayo Clinic reported eight deaths associated with the consumption of food and development of an allergic response. I don’t know the details, but I do know that 1988 was not a long time ago.
  2. Besides the United States, Canada, the EU, FAO and Codex Alimentarius recognize the Big 8 allergens. The Big 8 are dairy, egg, peanut, tree nuts, fish, shellfish, soybeans, and wheat. I wrote that list off the top of my head! Teaching the workshop helps. In the United States, the Big 8 are regulated under the Food Allergen Labeling and Consumer Protection Act of 2004. Other countries may recognize other allergens or include sulfites, which are technically not allergens.
  3. The Canadian Food Inspection Agency pulls food from the shelf and tests for undeclared allergens. Let that sink in.
  4. Very few universities teach the science of food allergens. With food allergens being the number one cause of recalls and food packaging being most responsible, students need to understand quality assurance in a food manufacturing facility and effective methods for cleaning to remove allergens.
  5. Fourteen different companies make test kits for allergens. Buyer beware. There are sensitivity and matrix differences that will get you significantly different results. You are not mandated, but are highly encouraged, to validate your allergen clean process.
  6. Food allergens cause up to 40% of eczema.
  7. Physicians were wrong to tell parents to not introduce peanut butter to infants. The American Academy of Pediatrics guideline for introducing peanut butter is at 4-6 months for infants at highest risk with other food allergies or severe eczema and earlier for infants at lower risk. It is best to blend the peanut butter in another food, to avoid its choking hazard. A peanut butter campaign for pediatricians is needed to reverse the thinking of physicians and well-meaning grandparents. Soon peanut patches will be available, like the technology of nicotine patches.
  8. A safe dose of each allergen does exist. While the US currently has a zero-tolerance policy for allergens, more research is needed to understand low thresholds for each allergen where an allergic response would not occur. In the future, we may move to defect action levels being allowed for each allergen, as the lowest amount allowed in food at a safe level for all.

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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Adult Education and the Responsibility of Lead Instructors

Give a man a fish, and you feed him for a day. Teach a man to fish, and you feed him for a lifetime. -Anne Isabella Thackeray Ritchie http://quoteinvestigator.com/2015/08/28/fish/

How do we learn?

I found the diagram below in an interesting blog at http://www.willatworklearning.com/2006/05/people_remember.html.

I started college in 1979 from the top portion of my high school class, good in math, science and Latin; an excellent reader; and a quick learner. After ten years of college, my first job was teaching at a technical college. I learned that most instructors teach and evaluate students in the way they are most comfortable. After ten years of college, I was most comfortable with lecture and exams. That doesn’t fly for most technical college students. Next I learned about learning styles as shown above in the four colors. Many of my students were kinesthetic, meaning that they would literally not learn until they did the hands-on work. Think of students studying auto mechanics. How do they learn? Not by reading the book! Other students didn’t learn until they had a chance to talk about the material; they were social. Some students were equal in all four areas of learning.

Next I learned about retention of learning. As shown in the diagram, it is generally regarded that we retain 10% of what we read and 90% if we immediately use the information we just learned. Of course every person varies with their personal percentage, but the numbers represent the population averages. Now I understand why reading assignments of material before a learning activity do very little on their own toward actually learning and retaining the information. The exception is people with photographic memories; my statement does not apply to them.

A third piece in learning is not pictured here. That is, we must be exposed to new information at least 21 times to learn. When a child learns their ABCs, they sing the song over and over and over. The bedroom has the letters as art. There are books. There are videos. There are CDs. Children are quick learners, so we need to give our adult selves a break on expecting to learn information. For example and in the PCQI workshop, PCQIs learn the definition and application of “corrections” compared to corrective actions. The PCQI participant reads the definition and term within the book, sees the term on the projection of the slides, hears the Lead Instructor say the term many times, and uses the term in discussion with their team. Will the participant retain the definition of the term? Maybe. There may not be enough exposures to the term for it to stick.

The design of the curriculum maximizes learning for a wide range of learners in the population given the time we have in the workshop. This is just a start.

Another really cool thing that is happening in our brain is myelination. We used to think our brain did not grow in adulthood. That is absolutely not true. As we learn new material, new cells are making connections to other cells. As that cell is used over and over with the new information, layers of myelin are added to stabilize and cement the new cell. Those of you in my generation, do you ever wonder why you can still sing, “876-5309?” Myelin! If you play an instrument and it has been years, you can sit down and it just happens. Riding a bike. Reciting lines in a play or football play call. Myelin!

I think it is pretty freaky awesome that there are hard-core researchers out there discovering how we learn and giving us cool diagrams like the one above. I distinctly remember when I learned about PowerPoint. It was about 1995, and PowerPoint was slowly added as a tool in adult education. Just think, all my learning before 2000 happened without PowerPoint.

Learning changed quickly due to electronics. Young adult brains are literally wired differently due to exposure to devices, compared to older adults. I attended a K-12 teacher conference around 2010. There were about 500 teachers in the room. The speaker showed a video in which a group of about six teenagers bounced a ball back-and-forth from person to person. We were instructed to follow the movement of the ball. Of course, I thought it was a lesson in team-building. At the end of the video, the speaker asked us to raise our hand if we saw the gorilla walk through the scene. Gorilla, what gorilla?!! How could I not see a gorilla? Looking around the room, all the teachers, fresh out of college, i.e. young, had their hands raised. What? The speaker played the video again, and yes, there was a large person in a gorilla suit casually walking through the scene. All the young brains wired on computers and electronics had seen all the action. In 2010, that was less than 10% of the audience. I would expect that number to increase annually.

As Lead Instructors, we have an obligation to not only present the material in the curriculum, but to facilitate adult learning. The workshop has been designed to teach the material with multiple exposures of information, to address different learning styles, and to maximize retention. Adult education goes beyond making sure our participants are comfortable in the room and enjoy snacks and beverages, which in my opinion are very important! It is critical to try to meet the needs of each learner. Following the design of the curriculum is a good start.

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.