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Looming on the FDA horizon is the enforcement of the last of seven foundational rules in the Food Safety Modernization Act (FSMA). Intentional adulteration, commonly called food defense, is the deliberate addition to an ingredient or food of a hazard to cause illness or injury which makes the food adulterated. This criminal act could be the work of an outside group or individual who gains access before an ingredient crosses the perimeter of your facility and is delivered at Receiving. Thinking inside the box requires you to consider the access of a disgruntled or temporary employee from Receiving through to the sealing of packaging, i.e. an inside job. Addressing both perspectives is required.

The deadline is July of 2019 for businesses with more than 500 employees. The description of the first companies to come under enforcement aligns with the PCHF rule. In July of 2020, small businesses with an annual revenue of $10,000,000 come under enforcement. You can see where is says ten million here. Yes, that means that businesses with an annual revenue under $10,000,000 are defined as very small businesses by FDA and are exempt from requirements other than providing documentation of the very small business status. The very small business exemption aligns with the PCHF rule. I have written more on the food defense rule in a previous blog post on ConnectFood.

Businesses with more than 500 employees are writing their food defense plan. Quality managers schooled in Hazard Analysis and Critical Control Points (HACCP) will see the parallel of steps in a vulnerability assessment to the hazard analysis process in HACCP or PCHF. However, a food defense plan and program have completely different outcomes compared to food safety. Your food safety team may not be the right people to address food defense, so now you have another team, and most companies bring in food defense experts for a fresh pair of eyes and their experience. I have previously written about resources for food defense. I teach a one-day workshop on food defense. My recommendation is to bring on-site a food defense trainer and consultant for one day of training with your cross-functional team, followed by two days in the facility for a vulnerability assessment with the food defense team leaders-no more than three people. Our own Matthew Botos, CEO of ConnectFood, is an excellent source of information on food defense.

“Any supply chain has the potential of being vulnerable from a multitude of unstable individuals who have both the operational capability and the behavioral resolve to inflict damage on products, people, or facilities. We have the most sophisticated and safest food supply in the world and FDA is only trying to bolster that with their continually proactive regulations. Companies need to not only look after food safety in a traditional sense, (look for hazards and protect the consumer) but also look at non-traditional methods that may impact the safety of the food supply. ConnectFood stands ready to help companies and protect people.” – Matthew Botos, CEO.

Food defense plans are facility-specific. My recommendation is that you choose one site from your company and completely finish its food defense plan. Once the team has learned the process, you can get the other sites started and either bring in the trainer again or create a corporate food defense team that goes to each of the sites to implement food defense with the local team. Because this is the first time that your food facility is required by FDA to address food defense, be prepared for large investments in monitoring of employees, capital expense, or reconstruction. One company I worked with is way ahead of the curve on food defense, yet I left them with a long action item list following one day of training and one day of touring the facility to identify vulnerabilities. We needed another day. After the company completes the action item list, I will review their draft food defense plan.

To get started on your food defense plan, FDA has publicly available and free documents. Go to the webpage for FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration. You want to start with the Fact Sheet and the Explanatory Diagram. The Question and Answer document is good. Scroll down to the questions on Intentional Adulteration, because the Q & A covers all FSMA rules. When you are ready, go through the first Guidance document. Others will be published through this next year. Matthew, the other ConnectFood food safety experts, and I can guide you through the system using the Expert Services; the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting LLC
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 has delivered over 20 workshops to the food industry. With 35+ years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an active communicator at all levels of 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 the 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.

The Food Safety Modernization Act (FSMA), which was signed into law in January of 2011, was created with the intent to regulate the way foods are grown, harvested, and processed. This rule allows the Food and Drug Administration (FDA) to step into the food safety chain to protect the public by assessing, regulating, and ultimately strengthening the food safety system. FSMA focuses on five main topics according to the FDA’s fact sheet, each of which has subtopics that relate to your food safety depending on the classification, facility size and employee count, and the purpose of your food company:

    1. Prevention
    2. Inspection and Compliance
    3. Response
    4. Imports
    5. Enhanced Partnerships

Back in November of 2016, we released a blog entitled “What is the Food Safety Modernization Act?”, which began our continuous discussion of FSMA. For the past few months, ConnectFood has been releasing blogs that touch upon the topics most relating specifically to the safe production and hazards around human food. For example, we discussed every aspect of record management regarding safe production, documentation, logs and records, and food safety plans. (Part 1, Part 2, Part 3, Part 4, Part 5, Part 6) We also discussed the importance of practicing mock recalls and the more specific and intimate details of recall planning and writing your food company’s recall plan.

Whether you are a food manufacturer, a distribution plant, a restaurant, small food producer, or anything in between, your facility or kitchen must be compliant with FMSA regulations. You should assume that an FDA Inspector will arrive to perform an audit on your facility at any time, on any day of the week. Sometimes, these visits are scheduled, but often, you should be ready for a surprise. Get ready to hand over your required documentation, explain your processes, justify your Good Manufacturing Practices (GMPs), and most of all, get ready to be expected to implement some changes.

Over the next few weeks, ConnectFood’s goal is to continue to educate you on the segments of FSMA and the regulations surrounding food safety policies. We will be having food safety experts write on the following topics:

1. Sanitary Transportation of Human & Animal Food
Sanitary transportation is an element of FSMA that has a rule finalized by the FDA. According to their online documentation, “The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation… The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.”

2. Foreign Supplier Verification
The final rule on foreign supplier verification began implementation on May 30th, 2017. The online documentation states: “The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders.”

3. Preventive Controls for Animal Food
As you know, ConnectFood talks about human food constantly, but there is equal importance in making sure our pets are fed safely. Let’s not forget our furry friends in our safety planning. Check out the FDA’s final rule fact sheet here until we release our blog on the subject.

4. Strategies to Protect Food from Intentional Adulteration
Intentional Adulteration is not a topic to skim through – we will be having our own Kathy Knutson, Ph.D., PCQI, (who is trained in the prevention of Intentional Adulteration) write a post focusing solely on the topic. Until you get to read her writing on the subject, take a read through of the FDA’s webpage here.

All of this information may be overwhelming no matter if it is old news or fresh news. As always, if you have any questions regarding FSMA and how it relates to your food company, the team at ConnectFood is always here to help. Don’t hesitate to reach out for help if you need it. The time for compliance is the present – don’t be caught without a FSMA-compliant food safety plan in place. Contact us.

About the Author

Johanna Seidel, PCQI

Johanna Seidel is an administrative member of the ConnectFood team, where she works as manager of operations and manager of social content. Johanna received her Preventive Controls Qualified Individual (PCQI) certification in November of 2017. She received a Bachelor of Fine Arts Degree upon graduation from West Texas A&M University in May of 2016. When she is not working with food safety experts, Johanna also works as a dance instructor for The Chicago School of Ballet, as well as a professional contemporary dancer in the city of Chicago.

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