The FSMA Intentional Adulteration Rule: Tools to Help You Comply

The Intentional Adulteration Rule is the final FSMA rule to go into enforcement. The compliance deadline for large businesses is July 26, 2019 — a little less than eight months away. If you haven’t started preparing your food defense plan yet, now’s the time. This article provides a brief overview of the rule and its requirements, and then highlights a few tools and technologies you can use on your path to compliance.

The Intentional Adulteration Rule is the final FSMA rule to go into enforcement. The compliance deadline for large businesses is July 26, 2019 — a little less than eight months away.

This rule is something completely new for the industry — it’s the first time companies have been required to develop a food defense plan. Because of this, the FDA plans to take an “educate before you regulate” approach. Jon Woody, the agency’s director of food defense and emergency coordination staff, said in an interview that the first inspections under this rule will be “quick check” inspections, where “inspectors will simply evaluate the food defense plans to make sure the required components are there.” More comprehensive inspections will come later.

In any case, you’ll want to be ready for those initial inspections. So, if you haven’t started preparing your food defense plan yet, now’s the time. This article provides a brief overview of the rule and its requirements, and then highlights a few tools and technologies you can use on your path to compliance.

The Intentional Adulteration Rule: Overview and requirements

FDA senior advisor Ryan Newkirk explains the purpose of the rule like this: “to protect food from a person or group of people who are intentionally doing something to the food to either cause illness or death on a large scale.”

Note that the rule specifically targets adulteration with the intention to cause widespread harm to the public, like an act of terrorism. It does not apply to economically motivated adulteration (e.g., substituting an ingredient for a cheaper one).

The rule requires companies to create and implement a food defense plan. For this, the FDA has followed a similar approach to the industry-standard Hazard Analysis Critical Control Point (HACCP) system. The food defense plan must include three main components:

  • A vulnerability assessment. Just like in the Preventive Controls Rule food safety plan, the first step is identifying hazards. In this case, the hazards are vulnerabilities, i.e., steps in a process where someone could potentially gain access to and contaminate the product. Newkirk gives the examples of “an open access hatch on a large, liquid food storage silo or a very large mixing vat that is open without a lid.”
  • Mitigation strategies. Companies must implement actions to minimize or prevent the vulnerabilities they identified in the vulnerability assessment.
  • Procedures for monitoring, corrective actions, and verification. Companies need to have procedures in place to make sure the mitigation strategies are properly implemented.
The rule also requires companies to provide training for staff who work around the vulnerable areas and maintain detailed records about the implementation of their plan. The plan must be reanalyzed every three years or when certain criteria are met (e.g., mitigation strategies not implemented properly).


Tools to help with compliance

Domestic food facilities, as well as foreign facilities that import food into the United States, must comply with the Intentional Adulteration Rule. Let’s look at four tools that can help you get started creating and implementing your plan.


Food Defense Mitigation Strategies Database

The FDMSD is a database of mitigation strategies companies might want to consider implementing. You can sort by category (e.g., cooking, filling, packaging) to view examples of mitigation strategies for each step of the process.


Food Defense Plan Builder

The Food Defense Plan Builder is a free software developed by the FDA to guide companies step by step through the process of developing a customized food defense plan.


FSMA checklist: Intentional Adulteration Rule

This 10-question checklist from Kestrel Management helps you quickly assess your current state of compliance so you can identify any gaps.


Third-party software

Several commercial software platforms are available that can assist with compliance. Here are two examples:
  • Safefood 360 is a FSMA compliance software. The food defense module allows users to develop vulnerability assessments, conduct food defense audits, and more.
  • SafetyChain is a food quality management system that also has FSMA compliance tools.

Check out these FDA resources for more information about the Intentional Adulteration Rule:


Also be sure to join us at the 2019 American Food Sure Summit. Several of our speakers will be addressing food defense and other aspects of FSMA. Darin Detwiler from Northeastern University will talk about the role of blockchain in food defense, Steven Mavity will discuss Bumble Bee Foods’ approach to compliance, and Chris Domenico from Safefood 360 will also be giving a talk. Explore the complete program.