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The FDA published the first of three announced guidance documents on June 19, 2018 for food defense. This release was less than one month after announcing they were “tantalizingly close” to releasing the first guidance at the 2018 Food Protection and Defense Institute conference. In the past, “tantalizingly close” has not been anywhere near soon, so I am happy for the FDA team that got this guidance done. The food defense rule for the prevention of intentional adulteration (IA) is the last of seven foundational rules of the Food Safety Modernization Act to be rolled out. If you are thinking “Whoa, I just figured out PCQI and my food safety plan,” then I suggest you start with the excellent FDA Final Rule Fact Sheets that summarize the FSMA rules and then go to the guidance documents.

Who needs to follow the Intentional Adulteration rule?
The FDA was very clear that the owner, operator or agent in charge is responsible.

    The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/ processes, packs, or holds food for consumption in the United States.

Here are some specific details. Just like the other FSMA rules, FDA rolls out the enforcement of the rule based on three sizes of businesses:

Businesses with more than 500 employees must comply in July 2019 by following a written food defense plan. FDA allows great flexibility on how a food defense plan is written and implemented, while providing detailed guidance. The food defense plan is a program for a facility and does not include the farm. The facility does not consider transportation to their location or transportation from their location in the food defense plan.

$10,000,000 is not a typo! The IA rule has a different definition of very small from the Preventive Controls for Human Food rule, the Produce rule or the Foreign Supplier Verification Program rule. Any business with less than $10,000,000 in annual revenue is exempt from compliance, and the business does not have to submit documents annually to the FDA to qualify. The business does have to provide documentation of annual revenue in person to an FDA inspector upon request for review and confirmation of the size of the business. Why, you ask?

The Intentional Adulteration rule is meant to prevent wide scale harm to public health.

From the guidance: Acts intended to cause wide scale public health harm are associated with intent to cause significant human morbidity and mortality… acts of disgruntled employees, consumers, and competitors are generally intended to attack the reputation of a company, and EMA [i.e. economically motivated adulteration] is intended to obtain economic gain.

Note! Businesses whose sole operation is the storage of packaged food are exempt, except for the holding of liquid food in tanks. See the guidance IV. Exemptions B. Holding of Food.

Note! Once the food has been wrapped in its initial food-contact packaging, subsequent packaging and labeling of the individually-wrapped portions into packs or cases for sale is not included in the food defense plan.

What training is available now?
FREE training is available now. Ahead of the guidance document, online and free training was posted. The training was designed for line workers and their supervisors for food defense awareness. The best defense is a trained and informed workforce. At the end of the 20-minute session, a certificate is printed and added to the employee’s personnel file. Additional training will be rolled out over the next year from the Food Safety Preventive Controls Alliance and other organizations.

The first guidance from FDA has so much more information. Even if you are exempt from the rule, I encourage you to read over the guidance and provide the free training to your employees. 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

Food defense is not food safety – defined, food defense is “the protection of food products from intentional contamination or adulteration by biological, chemical, physical, or radiological agents introduced for the purpose of causing harm.” Being a food safety geek, I recently returned to Minneapolis to attend the conference of the Food Protection and Defense Institute. FPDI is a Department of Homeland Security Center of Excellence, serving the food industry in the fight against intentional adulteration since 2004. As a food safety geek, I am intrigued about food defense and want to learn more. Maybe you are intrigued too. Here I have compiled five key resources for you to start your own journey down the path of food defense.

    1. Food Protection and Defense Institute

      I love the folks at FPDI. For people who think about crime for a living, they are really nice, normal people. At the conference they showcased local to international speakers, but their website is the star of the show. Here are some of the features of the FPDI website:

        • Food Defense Online Training
        • Food Adulteration Incidents Registry (FAIR)
        • World Factbook of Food
        • Food Defense Readiness Assessment
        • Focused Integration of Data for Early Signals (FIDES)
        • Intentional Adulteration Assessment Tool

      Finally, collaboration through two platforms:

        • CoreSHIELD
        • FoodSHIELD

      The platforms allow secure sharing of resources among the food defense community. FPDI works globally to monitor food defense.

    2. FDA at a Glance: FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration

      While most government documents are good for sleepless nights, I have learned to pay attention to fact sheets and question-and-answer publications from the FDA. These documents condense the information down to the most important facts. FDA published At a Glance documents for each of the seven foundational rules of FSMA. The Intentional Adulteration rule, AKA food defense rule, focuses on who is covered, what the key parts are for a food defense plan, compliance dates, and exemptions. As always, industry is welcome to submit questions to FDA about the rule through its Technical Assistance Network.

    3. FDA Voice, by Scott Gottlieb, M.D., March 28, 2018

      In FDA Commissioner Gottlieb’s blog post, We’re Committed to Guarding Against the Intentional Adulteration of Food and Implementing the New Rule Efficiently, we get the latest information straight from the top. I have seen and heard this article cited many times since its release. There is reference to FDA guidance in the article. At the FPDI conference, we were told the FDA guidance for the Intentional Adulteration rule is close to publication. Once available, that guidance will be another resource for industry.

    4. Food Safety Preventive Controls Alliance

      For food safety geeks, FSPCA is the go-to source for training and other resources. FSPCA is the hub for writing the curriculum for the Preventive Controls for Human Food, Preventive Controls for Animal Food and Foreign Supplier Verification rules. The food defense rule requires training also. The first food defense training from FSPCA is available now, and it is FREE! From the FSPCA website, According the IA rule, individuals assigned to work at actionable process steps and their supervisors, are required to receive training in food defense awareness (21 CFR 121.4(b)(2)). This training is called Food Defense Awareness for the IA Rule. Your employees will need about 20 minutes to complete the online training and a printer to print the training certificate.

    5. Matthew Botos, CEO, ConnectFood

      After September 11, 2001 ConnectFood‘s own Matthew Botos developed a food defense program for the food industry. He was ahead of the curve, as usual, taking action before the Food Safety Modernization Act of 2011 or even the signing in 2004 of Homeland Security Presidential Directive-9-Defense of United States Agriculture and Food.

Either food defense or food safety, we are all in this together. 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

Your company is generating a record right now. Somewhere in the facility there is monitoring, a new employee is being trained, or ingredients are being shipped to you. I have written in previous posts here on ConnectFood.com about required and recommended records. Below is an outline of topics which generate records in need of management.

What records must my company have?

    Good Manufacturing Practices (GMPS). Every food facility is required to follow GMPs.* You will feel confident in an inspection or audit if you have good documentation for GMPs.
    Standard Operating Procedures (SOPs)

      Sanitation Standard Operating Procedures (SSOPs) are required when a sanitation preventive control is identified in the hazard analysis and for some allergen preventive controls.*

    Training records*
    Hazard Analysis*
    Validation study for each process preventive control or critical control point*
    • Shelf-life study, recommended
    • Supply chain program

      Supply chain preventive controls are required for ingredients for which the supplier controls the hazard.*

    Receiving records for ingredients with a supply chain preventive control*
    • Monitoring and Verification*
    • Calibration of monitoring devices*
    • Equipment maintenance, recommended
    • Corrective action*
    Recall plan*

*Required by the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule.

“How do I store all these records?”

This is a question I always get in a training workshop. It usually starts with, “I have a HACCP plan” or “I have records for auditing” and proceeds to the concern of getting rid of everything that has been done up to now and starting over. The answer is an emphatic “No!” to starting over. Your company is not going to rid itself of the old systems and start with the new kid on the block. Everything you have done for record keeping is still valuable and fits into the new food safety or HACCP plan. The next question is harder. “How do I organize my food safety plan and my required records for audits?” Unfortunately, I can’t answer that question, because it is completely up to you.

Matthew Botos, CEO of ConnectFood, did have a response to the above question:

“Records are of the utmost importance in the food safety risk management system. As I have said probably thousands of times (as have my peers): “If you haven’t documented it, you have not done it.” Records have traditionally been paper records, but over the decades with advancements in technology we are now ready to “trust” electronic records. As always, they are only as good as the information we put into them. What I can tell you is that there are companies like ConnectFood which will facilitate the storage and retrieval of records. In the electronic world that we live in, electronic storage of records is no longer just the future, it is the present.”

When the FDA inspector requests review of an electronic record, there is no requirement to supply a paper copy or printout. Records can be stored in the “cloud” if they can be retrieved. Imagine being on the floor in operations with an inspector and you are asked for the pH meter calibration record from a year ago. You can pull up the record on your phone or tablet and move on to the next question.

For your ease of mind, it is important that you understand how electronic records are stored and retrieved at your company so that you can efficiently display the record for review. What I tell my workshop participants and clients is to find the person at your company who loves office supplies. This is the tell that they love to sort, store, and organize things. Do they have every color of highlighter? I do. Do they have a label maker? I do. While my desk is often messy, my office supplies are organized and labeled. If you need a pad of paper, this person knows exactly where to get one for you. This is the person you want to task with organizing records electronically, too. As quality manager or Preventive Controls Qualified Individual (PCQI) you have too much on your plate, and I want you to delegate when possible.

Once a system for records management is created, all food safety team members should be required to follow the system. There should be no stray records being held outside of the system and unavailable to the entire team. Never rely on one single person having access to part of the records. Store electronic records in a common location for two or more years.

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

I heard that inspections are looking more like audits than the historical walk-through and observation of employees working. Why is that? Documentation is required by law and tells the story of food safety. The success of your company inspection lies in your records. Today I am writing some good, general concepts and requirements on records management under the Food Safety Modernization Act’s Preventive Controls for Human Food rule.

What is the purpose of records management?
This is the way I look at it: your company (and most of the food manufacturers in the United States) are making and selling a safe product. The bad ones who intentionally sell harmful products go to jail – these are rare. Then there are the companies who think they are doing the right thing, and they simply do not know their product is potentially harmful. For example, there is the national recall of Romaine lettuce contaminated with E. coli O157:H7. Something is wrong with the Romaine system, and hopefully the problem will be found and fixed.

For everyone else, you are making a safe product. You are the expert for your ingredients, personnel, equipment, and customer base. However, when the inspector shows up at your door, what records do you have as proof that you are making a safe product? You have a written food safety plan, written procedures, and supporting documentation. Through good record management, you can show the inspector records from receiving to shipping. Have you ever sat on a jury panel? Like the lawyer presenting evidence for the case, your company compiles evidence of food safety and, in turn, presents that evidence to an inspector.

What counts as a record?
Any and every written document can build your case. Records can be handwritten, hard copy documents, or you can create them with an electronic record. A true copy of the record is made with a photocopy or scan of the original in case of an accident that destroys the bench sheet. In addition, handwritten records must be recorded in permanent ink, preferably blue or black, and at the time of the observation be neat enough to read and provide enough detail to prove safety.

What information is required on the record?
Information must be complete to document the safety of the product. As you think through the possibility of a product recall, what information would you need and what information does the FDA and state recall coordinator need? Every document created at your company must include the name and location of the company. Location is critical if there is more than one facility, such that the document shows where the record was made and reflects the safety of the product made at that location. On the record sheet, include the name of the record, date of record, initials of employee recording data, and signature or initials of the company’s Preventive Controls Qualified Individual (PCQI) for record review, along with the date of the record review. Note the time the observation was recorded too, if time is important. Record the name of the product and lot code for the batch. Again, think through what information you would need in the event of a recall.

Complete information discussed above is required in electronic records just like in a bench sheet. The same is true for a temperature chart or any record automatically generated. Don’t forget record review as a verification step by a PCQI.

What do I do with all these records?
It is completely up to you to choose paper or electronic records – or a combination of both! By law, you must store records related to food safety for two years. However, the food safety plan must be reviewed within three years, and if records are related to the food safety plan, those records may need to be stored longer. The easy part is electronic records – no matter where the data are stored electronically, if the record can be viewed on site, the record is considered stored on site. The hard part is paper records – if your company runs out of room to store boxes of records, they can be stored off site, provided that upon request of an inspector, the records can be retrieved within 24 hours. There are companies that provide off-site storage and retrieval as a service.

Going beyond the discussion of generalities, there are required records for hazard analysis; preventive controls and their monitoring, verification, and corrective action; validation; recall plan; training records and records in support of Good Manufacturing Practices. The folks at ConnectFood will design Record Management with you and are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through ConnectFood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

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

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

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

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

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

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

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

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

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

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

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

Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting

Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through ConnectFood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

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.

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.

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.

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.

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.