A NATIONAL FOOD SAFETY MONTH – SPECIAL POST
The Food Safety Modernization Act (FSMA) Final Rule provides us with guidance and law related to protecting food from intentional acts of contamination. To prevent an act of intentional adulteration (IA) that could cause harm to the public on a large scale, the FDA is implementing risk-reducing strategies to combat IA, as detailed in a recently required Food Defense Plan.
Strategies to build this plan include:
THE VULNERABILITY ASSESSMENT
The Vulnerability Assessment is the major starting step in the process. As Peter Drucker once said, “You can’t manage what you don’t measure”. While the FDA is not prescriptive in the methodology, they have discussed CARVER + Shock and the guidance from their Food Defense Plan Builder.
Some personal commentary on vulnerability assessment…
The encouraging news from the recent FDA call with industry is that they are socializing Key Activity Types (KATs) as a legitimate vulnerability assessment method for the private sector. I believe this is great news for food producers and with some modifications, will provide an excellent vulnerability assessment model.
US GOVERNMENT VULNERABILITY ASSESSMENT PROJECT
From 2005 – 2008, the FDA, USDA, FBI, and DHS conducted CARVER + Shock threat assessments on 36 products, processes, or commodities in the food and agriculture sector. Afterwards, the FDA conducted another 18 assessments on products not previously assessed and updated another 16 that were previously examined.
Unfortunately, much of the data that resulted from these product, process, and commodity assessments are classified and cannot be shared with the industry!
What can be publicly shared is found here: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm347023.htm
SOUND DOCUMENTATION IS IMPERATIVE
Examining the IA Rule, we want to ensure a complete food defense process, along with good documentation of our process, and why we made the recommendations and decisions we determined reasonable and appropriate. We would also want to document our reasoning for discounting certain traditionally vulnerable processes or areas.
Our process should look like this:
The Food Defense Plan
KEY ACTIVITY TYPES (KATs)
Examining the Key Activity Types (KATs) model, we see that the FDA determined that processing steps can be grouped, based on the types of activities are being carried out during the food production process.
FDA IDENTIFIED KATs
II. Ingredient Staging/Prep/Addition
III. Liquid Receiving/Loading
IV. Liquid Storage/Hold/Surge Tanks
We can examine the processing on our site and identify those points that present us with the most risk. We can apply the term Actionable Process Steps to these items.
For each point, step, or procedure we must consider at a minimum the following:
SPECIAL NOTES OF CAUTION:
KATs AND THE THREE FUNDAMENTAL ELEMENTS
In this chart, we see that the FDA has organized common vulnerabilities into generalized activity groups – Key Activity Types. They are linked to the three fundamental elements, as required.
THE FDA’S VIEW OF KATs
Key Activity Types, when combined with other physical security methodologies and body of knowledge can bring a Corporate Security Department to the leadership pinnacle. In my opinion, Key Activity Types presents us with a workable model to build on any existing food defense and food safety strategies. KATs helps us create a science-based Food Defense Vulnerability Assessment program that will:
I would very much enjoy continuing this Food Defense discussion with you, the corporate security or food defense professional. As a Certified Food Defense Coordinator with many successful, hands-on vulnerability assessment projects during my career, I look forward to exploring with you new ways of thinking about old problems. PRS believes in charting new courses and approaching each project with a tailored approach. If KATs and some related tools are of interest to you, reach out and let’s have a chat. You can book a call with me through my calendar link: calendly.com/joez
Please forgive the FDA slide quality. They were the only slides available to us from the source at time of writing.