FSMA Intentional Adulteration Rule

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.