Intentional Adulteration: What Does FSMA Mean?

    Posted by Chelsey Davis on Mar 31, 2016 10:09:30 AM

    Intentional Adulteration: What Does FSMA Mean?

    The Intentional Adulteration Rule (formally know as the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration) of the Food Safety Modernization Act (FSMA) will help to protect against the intentional adulteration of food, and will require facilities to implement mitigation strategies to prepare and protect the food supply chain at specific vulnerable points.

    Intentional Adulteration Categories

    When talking about food defense, we’re talking about the Intentional Adulteration Rule in which there are four subcategories of activities (listed above). Each category deserves individual attention and each of these categories are discussed in the preamble to the Intentional Adulteration Rule.

    Economic Adulteration 

    Economic adulteration is one of those forgotten cornerstones of the Food, Drug, and Cosmetic Act (FD&C Act), but has been a component as a form of adulteration since 1906. The passing of the 1906 act was really motivated in part by companies passing inferior ingredients as superior or whole ones—economic adulteration as it’s defined. Yet in prioritizing resources, the FDA has, for the most part, not enforced economic adulteration. What the FDA has said in the preamble to the Intentional Adulteration Rule is that since the motivation behind economic adulteration is economic gain and not large scale public harm, it will be pushed towards the Preventive Controls Rule (HARPC) as part of the food safety plan. So even though it is a form of intentional adulteration, it’s going to fall under the HARPC portion of FSMA and not the Intentional Adulteration Rule.

    Disgruntles (Employees, Competitors, Consumers)

    Looking at the other categories under intentional adulteration, there are a couple of different buckets when it comes to employees and others (competitors and consumers). What the FDA states in the preamble to the Intentional Adulteration Rule is that the aim of the disgruntled employee is really to tarnish the reputation of and/or seek revenge against his or her employer. A perfect example of this comes with the recent video of an employee seen urinating into a batch of Rice Krispies. While this and other forms of adulteration may have some ramifications to the public, it’s not considered the large scale intentional harm that this rule is focused on.

    Because behavior like this is aimed at the employer from the employee, it’s not covered under the Intentional Adulteration Rule. So if it’s not covered by this rule, is it covered under the food safety plan? For example, if the HARPC rule was in place today, would Kellogg need to evaluate its food safety plan to determine whether this type activity now merits inclusion into the plan?

    This same type of activity can happen with competitors or disgruntled consumers as well.  But again, the FDA says it’s not about public harm and is more so about seeking revenge against the company from a consumer’s or a competitor’s standpoint.

    Large Scale Public Harm

    For the purpose of the Intentional Adulteration Rule, you can, for the most part, disregard the forms of intentional adulteration we just discussed. Those three forms of intentional adulteration fit the definition—they are forms of intentional adulteration—but they are included (in some fashion) within HARPC.

    What is being discussed under the International Adulteration Rule of FSMA is large scale public harm—acts of terrorism or something equivalent. The key here is the scale. You might see some of this under the disgruntled employee category if the employee does something more than, say, urinating into the production line, but more along the lines of poisoning. When this type of behavior is present, then it can cross that line into large scale public harm. 


    The key to the Intentional Adulteration Rule is performing a vulnerability assessment to determine what areas of operation need to be included in a food defense plan. All facilities are going to be covered in this rule with a few special cases for dairy and a few exemptions, but if you are a FDA-registered facility, you need to do a vulnerability assessment. 

    Each facility has two options.

    Option 1: You can look at the 4 key activities listed below (bulk liquid, liquid storage, secondary ingredient handling, or mixing and “similar activities”), which are deemed vulnerable areas within facilities, to determine if any of your operations fall under one or more of these categories.

    Categories for Vulnerable Areas

    Option 2: You can conduct a vulnerability assessment independent of these four activities. When you look at your facility from products coming in to finished product leaving—including the shipping part of your operations—you can determine where the vulnerabilities might be. The FDA provides a number of resources to help aid in this process, but it highly recommends the CARVER plus shock vulnerability assessment to identify those areas within the facility that require a mitigation step.

    The two options listed above are nearly the same. The activities the FDA has identified are very broad, meaning there are not big differences between option one and option two. Option one does provide a structure if you haven’t created a food defense plan before and also allows it to be a little more focused. Either option is going to cover the full extent of the facility and uncover areas where a vulnerability might exist.

    Similar Concept?

    The vulnerability assessment starts the framework for the Intentional Adulteration Rule and the food defense plan. You’re looking at significant vulnerabilities and taking steps necessary to prevent intentional adulteration at those vulnerable areas. This should start to sound a little familiar, as the food defense plan is similar to HACCP-style plans as well as the Preventive Controls Rule’s food safety plan.

    Examples of how a food defense plan is similar to HACCP

    For example, In HACCP, you would use the term critical control points, but here in the Intentional Adulteration Rule, you’re going to use the term actionable process step. The process is exactly the same. With the Intentional Adulteration rule, you’re not looking at a food safety risk like physical or chemical hazards, but you’re more so looking at vulnerabilities where food defense measures would help mitigate the possibilities or opportunities for intentional adulteration.

    Like the diagram illustrated above depicts, instead of using the term preventive controls, you’re using mitigation strategies. It's the same concept in which you are looking at controlling the risk identified in the first step of this process. In HACCP, you look at the critical control points identified and implement preventive controls to help mitigate the hazard, and with intentional adulteration, you’re looking at the hazard identified in the actionable process step and implementing mitigation strategies to reduce the vulnerability to an acceptable level.

    The aim of the mitigation strategy is to provide assurance that significant vulnerabilities at each step will be mitigated or prevented from intentional adulteration. These are going to be really specific and tailored to your facility. They must match what you’ve identified in the process step. You will need to provide a link on matching specific measures to the actual process step, write it down and justify the use, put a monitoring schedule/activity in place, and identify corrective actions as needed. 

    Below is a list of some of the common mitigation strategies that are typically outlined under each category.

    Examples of common vulnerabilities listed in each category.

    In the next step—monitoring, correcting, verifying—the food defense plan is virtually the same as in HACCP plans and the food safety plan. You’re involved in monitoring to ensure the proper procedures are in place, setting the frequency to verify the mitigation steps are in place, and verification to ensure these plans are working (at a minimum of every 3 years to revamp, review, and overhaul these food defense plans). This isn’t something you put in a binder and place on a shelf to collect dust, it’s a living document.

    As with all other FSMA rules, training and recordkeeping will be an important piece to this. All employees will need to be aware of food defense as a concept—you want a routine among employees of being aware of food defense. With this food defense plan, you’re going to be generating numerous records. At the very minimum, you will need documentation on training, monitoring, verification, corrections, etc. All of these will need to be documented for compliance purposes.

    Again, this is a similar concept seen in HACCP and HARPC, you’re just adding food defense to it. You’re taking elements that were maybe voluntary or “best practices” before and you’re now making them a required element. 

    Download the FSVP Outline 

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