Beyond Compliance: FSMA’s Food Defense Plan
In the May FSMA Friday: Beyond Compliance session, sponsored by SafetyChain, Senior Manager of Food Safety TAG’s Christopher Snabes and Vice President of Public Health Rolando González, Ph.D. discussed The FSMA Food Defense Plan: FDA Expectations on Training and Options on Writing a Food Defense Plan.
The Food Defense Plan is the fundamental component of the Intentional Adulteration (IA) Rule of FSMA which establishes requirements that companies need to fulfill to prevent or significantly minimize intended, wide-scale public health harm. The rule is primarily applicable to large facilities and differs from other FSMA rules in that it covers mitigation reduction to address significant vulnerability in processing rather than covering food or hazards. Additionally, food and beverage manufacturers not previously under FSMA (such as dietary supplements, bottled water, low-acid canned food, and those subject to seafood and juice HACCP) are required to comply with this rule.
The two most important aspects of the rule are the written Food Defense Plan (FDP) and training. The FDP, which is HACCP-like in nature, is due for large facility by July 26, 2019. As shown in the graphic above, it begins with a vulnerability assessment, through which an actionable process steps are identified, then mitigation strategies implemented. The process and strategies are monitored to ensure they are being done; corrective action identified and implemented when needed, and verification conducted. The FDP is to be reanalyzed at specified times or triggers; and all is to be document.
As to training, there are requirements for awareness and FDQI specialized training:
Under the rule, every employee required to take Food Defense Awareness Training – just awareness of what food defense is. It can be presented by anyone with knowledge, and there is a free 20-minute on-line course available from FSPCA or you can have a consultant conduct the training.
There also is general overview training of the IA Rule, for which a free on-line course also is available.
Key Activity Types (KAT) training for conducting vulnerability assessments is available online with a fee from FSPCA and is approved by FDA. Completion includes a Certificate of Training. You can view the slides without a fee but cannot interact with it or receive a certificate.
Similar to KAT training, FSPCA has an online Identification and Explanation of Mitigation Strategies course, available on-line with a fee and receipt of a Certificate of Training; or just slide viewing without a fee and no certificate.
Conducting Vulnerability Assessments. This fee-based course, for which participants receive certificates, can only be taught in person by lead instructors who are approved by the FSPCA & AFDO. TAG has a certified lead instructor. Participants are strongly encouraged to take KAT training first.
You also can establish that you are trained without FSPCA courses through education and/or
on-the-job training as long as it is documented.
To jump back to the FDP, there are steps that need to be taken prior to FDP development. Similar to the Food Safety Plan, these include assembling a food defense team with multiple backgrounds; writing a process flow chart; determining who needs to become a food defense qualified individual (best practice is two per site); and conducting an initial vulnerability assessment to determine your KATs, of which four types are recognized by bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, and mixing and similar activities. These are determined by FDA to be of highest risk.
In writing your plan, there are some options:
1. Write your plan based on the KATs identified during the initial vulnerability assessment.
Pros: Easy to identify, quick to do, FDA recognized as acceptable
Cons: Each KAT automatically become an actionable process step (APS), so it may create unnecessary mitigation step(s) which may increase the burden.
2. Conduct vulnerability assessments at each process step using the Three Elements
Using the process flow chart, apply metrics to determine which process step can be identified as a KAT and become an APS. This specifically addresses the “inside attacker.”
The three fundamental elements are considered and scored using a pre-determined scale, or an internal scale with written justification. This assesses each step to determine if it is a KAT that will be a potential APS. The three elements are:
Criticality: the potential public health impact (e.g., severity and scale) if a contaminant was added.
Accessibility: degree of physical access to the product
Vulnerability: ability of an attacker to successfully contaminate the product
Pros: It is very thorough, and eliminates Inherent Characteristics from becoming a KAT.
Cons: You must have detailed explanation of why a KAT is or is not an APS based on FDA scoring or justify an alternate scoring system in writing. FDA will scrutinize your dose factor, and you may not realize all potential modes of contamination that are classified by Homeland Security and the FDA, leading to potentially inadequate scores, thus an inadequate Food Defense Plan
3. Hybrid Vulnerability Assessment
Using just the identified KATs, you can apply the three elements to determine a metric to establish an APS.
Pros: It is easy to identify, fairly quick to do, FDA recognized as acceptable, thoroughly explains your decision process for FDA, can defend spending or not spending capital investment for a mitigation strategy
Cons: Hard to perform without taking the IA VA instruction course. Similar to #2, you may not realize all potential modes of contamination.
In wrapping up the session, the presenters focused on a few additional areas important to understand in the IA Rule. The Food Defense Plan Builder (v1.0) that is currently available is not fully aligned with IA Rule. However, v2.0, which is expected late summer/early fall of 2019, will be fully aligned and allow you to upload the information you have in v1.0. Also forthcoming from are the FSPCA Training on Food Defense Plan Writing and Reanalysis and the third installment of the Food Defense Guidance document. Additionally, FDA has said it will not begin IA Rule inspections until March 2020. Once started, FDA will take a phased-in approach, with quick-step inspections, likely at the end of a preventive controls inspections for the first two years.
But you are encouraged to not wait for these – FDA expecting you to have your workers trained and your FDP in place.
This is a recap of our FSMA Friday webinar, and while we're happy to provide a summary of these sessions, it pales in comparison to sitting in on our live discussions and Q & A with TAG's experts. We proudly partner with SafetyChain to host these webinars monthly, and we invite you to join us! Additional information and registration links are available on our events page.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com