Growing up, my grandfather used to tell us that we had to learn from the mistakes of others because we will not live long enough to make all the mistakes on our own. That said, US–based companies need to stay informed on what is going on around the world related to intentional adulteration.

Australia had an incident in September 2018 related to needles found in strawberries where eventually a young male was found guilty of the intentional contamination. Another incident took place in July 2017 with  millions of chicken eggs were blocked from sale or withdrawn from the market in the Netherlands, Belgium, Germany and France after elevated levels of fipronil were discovered by the Dutch food and product safety board, because the use of fipronil is illegal in the production of food for human consumption in Europe. A criminal investigation was initiated.  

It is vital that all food processors have a robust Food Safety Systems in place to ensure such incidents do not affect their overall process. Here in the United States in March 2019, there was a recall of nearly 200,000 pounds of Ready To Eat Pork Sausage products produced by a USDA inspected establishment between January 16 and March 7, 2019 due to product tampering after the production process that may have resulted in product contamination.

The Food Safety Modernization Act (FSMA) enacted 7 rules to make the US food supply chain safer. One of those rulings, known as Mitigation Strategies to Protect Food Against Intentional Adulteration, is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.

This rule applies to both domestic and foreign companies that are required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act. It requires facilities to implement a Food Defense Plan with at least two elements: a vulnerability assessment and mitigation strategies. The latter requires monitoring, corrective action, and verification activities. Large facilities with more than 500 employees will have to be in compliance by July 2019, and all facilities, regardless of size must be in compliance by July 2021.

The million dollar question many facilities may ask themselves is, “how do I go about developing and implementing such a program?” The first step in conducting the vulnerability assessment is to develop a food defense program, that include at a minimum a vulnerability assessment and mitigation strategies. As of result of FSMA’s new rules, the FDA realized it needed to update its tools and educational materials to align with the relevant provisions of the final rule. As a result the Food Defense Plan Builder is now available to the food industry. The Food Defense Plan Builder is a user-friendly software program designed to assist owners and operators of food facilities with developing personalized food defense plans for their facilities.

The Food Defense Plan Builder walks the user through several sections that contain: Company Information, Broad Mitigation Strategies, Vulnerability Assessment, Focused Mitigation Strategies, Emergency Contacts, Action Plans and Supporting Documents.

The plan builder requires to enter company specific information related to food defense to be able to complete the vulnerability assessment, based on the provided information, adequate mitigation strategies (if absent) are then determined. During the assessment, you will identify the Actionable Process Steps at your facility and mitigation measures to reduce risk at these steps. While using the plan builder is not mandatory, it is with no doubt the easiest way a facility can complete the required elements for this new rule. Additional resources to complete the vulnerability assessment include the Food Protection and Defense Institute from the University of Minnesota that offers the Food Adulteration Incidents Registry. Another option is the Food Fraud database offered by Decernis (formelly run by the USP), this database is mostly used for food fraud related issues. And yet another option is Horizon Scan which offers access to a rapid overview of potential and emerging food safety issues on a global scale. These are just a few of the resources currently available to the Food Industry. While you may have used or heard of other tools, which option to use is not important.  The most important aspect is to make sure the vulnerability assessment is completed.

Once the assessment has been completed, you then need to identify the mitigation strategies, and those would vary greatly depending on the risk level, which may include additional security measures, frequent monitoring of vulnerable areas, or increased frequencies for product testing and sampling. The final piece of the puzzle would be to monitor and verify that the control measures implemented by you or your supplier are working as intended.

Take my grandpa’s advice and learn from what is going in the US and around the world with intentional adulteration incidents. Make sure you have a robust food defense plan that includes monitoring your supply chain and most importantly protect your processing environment. If you are going to make the news, let it be for good reasons and not for food safety related incidents. Don’t wait until the deadlines to comply but take prudent actions now to protect your food supply and not wait until you are out of compliance by the FDA mandated compliance dates.