FSMA’s Intentional Adulteration Rule, also referred to as the “food defense rule,” is intended to protect the food supply from potential large-scale harm that could threaten consumers and put food companies’ bottom line at risk. The rule requires facilities to create a written food defense plan in which they must identify areas
of their operation vulnerable to intentional adulteration and devise strategies to mitigate that risk.
We’ve asked our team of experts to help clarify what the rule means for your facility and how to build your food defense plan to comply.

*Disclaimer: answers do not represent the official viewpoint of the FDA. All regulatory questions should be directed to the FDA.

Q. If a person intentionally contaminates food, is it considered a form of terrorism or just vandalism? Or would it be based on quantity?

John Larkin: Intentional acts of adulteration of food usually only take two forms; sabotage and terrorism. Both pose a public health risk. 

Q. What is the best strategy to prevent internal employee threats?

John Larkin: Not any ONE way is going to be totally effective. Some of the components to an overall program might include:

• Background checks (as allowed)
• Training, rewards for proper behavior
• Development of a “See Something-Say Something” culture
• Employee engagement on identifying and reducing risks from sabotage or terrorism, program to report suspicious behavior
• Employee ownership of safety and defense plans, and teaching employees how to identify characteristics of threat actors

If there are high (or very high) risk areas, you might want to include pay adjustments and/or a buddy system.

Q. Do transportation companies need to have a food defense plan as well?

John Larkin: Within the preamble of the intentional adulteration rule there is discussion about the responsibility of the transportation company. The expectation is that the shipper and the receiver will have mitigation strategies in place to protect against vulnerabilities related to transportation. Thus, there does not appear to be an expectation for transportation companies to have a food defense plan. If the transportation company is involved with holding the food product they would probably be expected to have a food defense plan. With this being a regulatory type question, it is best if it were submitted to the FDA Technical Advisory Network (TAN) for an official response.

Q. Are retail companies required to have a food defense plan?

John Larkin: Once we (food manufacturers) send our products to retail companies, it is out of our hands to protect. Could we still be held accountable for intentional adulteration that takes place after we hand off the product? Even if the receiving company is not required to be in compliance with 21 CFR 121, it still is advisable for a food company to consider the overall safety of their product for the entire food chain – i.e., tamper evidence.

Q. Can mock drills and Red Team exercises be implemented as part of a food defense plan? Can you give an example of good scenario for a mock event?

Holly Mockus:  In my opinion, mock exercises are some of the best ways to assess and verify whether your food defense plan is working as designed.  Running through a scenario and ensuring all stakeholders (internal and external) participate to the fullest will highlight any gaps in the program.  External participants may include local law enforcement, local Department of Homeland Security, USDA, or FDA personnel, just to mention a few. 

Additionally, conducting a retrospective post exercise will provide you the opportunity to close any identified gaps proactively. Both USDA and FDA have some very nice tools with scenarios available at the following links:  USDA Food Defense Tools, Resources, and Training ; FDA Food Related Emergency Exercise Bundle (FREE-B). I would recommend starting with one of these and then developing them out each year to represent your specific facility, processes, products, etc. Include all levels of your organization, suppliers, transportation partners, and others within your supply chain to develop a very robust program that is fully implemented, understood, and top of mind when needed.

Q. I understand the importance of establishing a culture of trust with employees, but I don’t know where to start. Any suggestions on first steps?

Holly Mockus: Here are a few suggestions:

• Realize that trust is earned — and it has to be earned every single day. Walking the walk and talking the talk for leads, supervisors, and managers — actually, everyone — is critically important to a culture of trust.

• Follow up, always! If an employee provides you with some information, a concern, a problem or a suggestion, do something with it. Deaf ears don’t make for a strong culture of trust.

• Close the loop. Go back to the employee and let him or her know what you did, whom you spoke with, and what the outcome was. If you don’t tell them what you did with the information they provided, they will be less likely to talk with you in the future.

• Honesty is golden. Sometimes the employee will provide you with information that is not actionable or does not work out in the best interest of all stakeholders.  Provide this honest feedback — let them know you listened and you followed up.

• Use praise to reinforce. Recognize the behavior and the outcome. Let employees know that they are protecting the livelihood of all employees when reporting something out of the ordinary.

Q. Is HARPC a good system for preventing intentional adulteration?

Holly Mockus: Using preventive controls as a foundational element in a food defense program can make perfect sense.  The flow chart provides a great starting point for conducting the vulnerability assessment.  The hazard analysis template can be modified to use as documentation to capture the assessment and determination of mitigating strategies.  Remember that Preventive Controls focuses on food safety, whereas Intentional Adulteration focuses on the vulnerabilities of the product, facility, and processes — as well as the behaviors of intelligent adversaries. 

Don’t forget to include hiring practices, the facility and outside grounds, visitor procedures, contractor practices, and other non-food areas and practices as part of your food defense assessment for conducting the vulnerability assessment.  The hazard analysis template can be modified to use as documentation to capture the assessment and determination of mitigating strategies.  Remember that Preventive Controls focuses on food safety, whereas Intentional Adulteration focuses on the vulnerabilities of the product, facility, and processes — as well as the behaviors of intelligent adversaries. 

ABOUT THE EXPERTS 

John W. Larkin, Ph.D. 

Dr. John W. Larkin is the Research Director at the Food Protection and Defense Institute (FPDI). Dr. Larkin manages the research program of FPDI, which includes research conducted at FPDI and projects funded by the Department of Homeland Security (DHS) through the FPDI. Research areas include agent detection, supply chain, information sharing, risk analysis, and economically motivated adulteration. Dr. Larkin joined FPDI after 27 years with the U.S. Food and Drug Administration, where he managed a research program on shelf-stable and extended shelf-life foods, and evaluated pertinent regulatory issues for technology used to preserve food.

Holly Mockus
Holly Mockus is the Senior Product Manager at Alchemy. Holly has over 30 years of experience in the food industry with companies including ConAgra, Kellogg, and Sara Lee. She has held leadership positions in food safety, quality assurance, sanitation, and plant regulatory affairs. She was honored with the 2013 SQF Outstanding Achievement Award and was named 2016 Food Logistics Champion. Holly is passionate about the importance of training in the food industry.