This document summarizes a webinar on writing a robust food defense plan and preparing for FDA quick checks. The webinar covered FDA expectations for food defense training, options for writing a food defense plan including using key activity types or a three-element vulnerability assessment, and examples of potential questions that may be asked during a quick check inspection. The webinar aimed to help facilities understand FDA requirements and be prepared for upcoming quick checks of food defense plans and documentation.

1. FSMA Fridays Webinar Series
Unpacking the IA Rule,
Writing a Robust Food Defense Plan, &
Preparing for FDA Quick Checks
with Christopher Snabes
August 28, 2020

2. ✔ FSMA Related News
✔ Regulation Changes & Updates
✔ Industry Trends
✔ Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS

3. ✔
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safetychain.com > Resources >
Before We Get Started
FSMA FRIDAYS

4. Featured Panelist & Host
FSMA FRIDAYS
Christopher Snabes, MS
Director, Food Safety
● 18+ years food industry experience
● Certified food scientist, food microbiologist
● One of very few authorized Lead Instructors
for the Vulnerability Analysis component of
food defense plans
Aaron Bolshaw
VP Marketing

5. FSMA FRIDAYS
The Latest FSMA Updates
•July 10, 2020: FDA prepares for resumption of domestic inspections with
new risk assessment system
• This may include a “Quick Check” of Food Defense Q & A
•The Food Defense compliance date for small businesses (those with fewer
than 500 employees) is July 27, 2020
• Enforcement via a “Quick Check” will begin in March, 2021
• Examples of potential “Quick Check” Questions at end of today’s presentation and a link
to a Prep List

6. FSMA FRIDAYS
This Month’s Discussion
The FSMA Food Defense Plan:
1. FDA Expectations on Training
2. Options for Writing a Food Defense Plan
3. What to Expect from Quick Checks

7. FSMA FRIDAYS
The IA Rule Basics
• Covers domestic and overseas facilities that manufacture, process, pack or
hold human food
• Includes Food and Beverage Manufacturers not impacted by FSMA previously:
• Low Acid Canned Food
• Seafood HACCP
• Juice HACCP
• Dietary Supplements
• Bottled Water
• Infant Formula
• Food Defense Plans were required to be written by July 26, 2019 for the
largest facilities
• The Food Defense Plan is site/facility-specific

8. FSMA FRIDAYS
8
Documentation
KAT or every
“Point, Step,
Procedure”
(3 elements)
Training
FDQI &
Awareness
KAT (Key Activity Types)
FDQI (Food Defense Qualified Individual)
Food Defense Plan Actionable
Process
Steps
The IA Rule Basics

9. POLL QUESTION
Let’s see how everyone on the call is handling written plans.

10. FSMA FRIDAYS
Types of Food Defense Training via FSPCA
and becoming a “Qualified Individual” per Topic
• Overview of the Intentional Adulteration Rule.
Free online course available.
• Food Defense Awareness Training. Requirement for
all employees at an Actionable Process Step and their
immediate supervisors (satisfies 121.4 (b)(2)). Free online
course is available.
• Conducting Vulnerability Assessments using
“Key Activity Types” (KAT) only. This course is
on-line with a fee, and comes with a Certificate of Training.
Slides are available to view, no interaction, without a fee,
and no certificate.

11. FSMA FRIDAYS
Types of Food Defense Training via FSPCA
and becoming a “Qualified Individual”, continued:
• Identification and Explanation of Mitigation Strategies. This course is on-line with a fee, and
comes with a Certificate of Training. Slides are available to view, no interaction, without a fee, and no
certificate.
• Conducting Vulnerability Assessments. This course can only be taught in-person by Lead
Instructors approved by the FSPCA & AFDO (TAG has two VA LI’s on staff). This is a fee-based course,
and comes with a certificate of training. KAT and Mitigation training is STRONGLY encouraged prior to
taking this course.
• Food Defense Plan Preparation and Reanalysis. This course is on-line with a fee, and comes with
a Certificate of Training. Slides are available to view, no interaction, without a fee, and no certificate.
• Can establish you are trained without FSPCA courses via education and/or on-the-job
training as long as it is documented.

12. FSMA FRIDAYS
Steps Before the Food Defense Plan is Written
• Assemble a Food Defense Team with multiple
backgrounds
• Write a Process Flow Chart
• Determine who needs to become a Food Defense
Qualified Individual per Topic
• Conduct Initial Vulnerability Assessment –
determine your KATs:
• Bulk Liquid Receiving and Loading
• Liquid Storage and Handling
• Secondary Ingredient Handling
• Mixing and Similar Activities

13. FSMA FRIDAYS
Option 1: Write Your Plan Based on KATs
• 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). May create
unnecessary mitigation step(s) which may lead to increased capital expenditure,
additional personnel, and potentially misses an APS.

14. FSMA FRIDAYS
Option 2: Conduct Vulnerability Assessment at Each Process Step Using the 3 Elements
• Using the Process Flow Chart, apply metrics to determine which process
step can be identified as a KAT and become an APS. Specifically
addresses the “inside attacker.”
• The three fundamental elements are considered and scored using a predetermined
scale (you can use an internal scale if there is written justification)
• Assesses each point, step, or procedure to determine if it is a KAT that will be a
potential APS

15. FSMA FRIDAYS
The Three Elements
Element 1
Criticality
Potential public health
impact (e.g., severity &
scale) if contaminant
was added
Options:
• Volume of Food at Risk [Simple to Complex]
• Representative Contaminant: Uses the FDA default dose multiplication factor (40 mg)
[Simple]
• Contaminant-Specific Analysis: Assesses every known potential contaminant dose at each
step [Complex] (may be preferred by in-house toxicologists)
Element 2
Accessibility
Element 3
Vulnerability
Degree of physical
access to the product
Ability of an attacker to
successfully
contaminate the
product

16. FSMA FRIDAYS
Pros and Cons of Three Elements Approach
• Pros: Scale is pre-determined by the FDA. Flexibility
allowed in using Element 1. When using the Representative
Contaminant approach, the FDA recognizes the default
factor in Element 1 for you, very thorough, and eliminates
Inherent Characteristics from becoming a KAT.
• Cons: Must have detailed explanation of why or why not it
is an APS based on score. You must justify in writing if you
use a different scoring scale. FDA will scrutinize your own
dose factor if using Contaminant-Specific Analysis in
Element 1, 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
inadequate Food Defense Plan as a whole.

17. FSMA FRIDAYS
Option 3: Hybrid Vulnerability Assessment
• Using just the KATs identified you can apply the three elements to determine a
metric to establish an APS
• Pros: Easy to identify, fairly quick to do, FDA recognized as acceptable, allows for thorough
explanation to FDA your decision process, excellent use to defend spending or not spending
capital investment for a mitigation strategy
• Cons: Hard to perform without taking the IA VA instruction course. If using
Contaminant-Specific Analysis of Element 1, you may not realize all potential modes of
contamination that are classified by Homeland Security and the FDA, leading to potentially
inadequate scores, thus inadequate Food Defense Plan as a whole

18. FSMA FRIDAYS
Mitigation Strategy Management Components
•For each APS you must implement
• Food Defense Monitoring Procedures
• Food Defense Corrective Action Procedures
• Food Defense Verification Procedures
• And of course, for each step along the way, you must retain records for a
minimum of two years
• (See Mitigation Strategies to Protect Food Against Intentional
Adulteration: Guidance for Industry, February 2020)

19. FSMA FRIDAYS
Reanalysis
Similar to a Food Safety Plan, The Food Defense Plan must be reanalyzed a
minimum of once every three years, or for the following reasons:
• Whenever there is a significant change that creates the potential for a new
vulnerability or a significant increase in one previously identified
• When there is new information about potential vulnerabilities associated with
a food operation or facility
• When a mitigation strategy is not properly implemented
• Whenever FDA requires reanalysis to respond to new vulnerabilities, credible
threats, or developments in scientific understanding

20. FSMA FRIDAYS
Next Steps
• Option: Current Food Defense Plan Builder, v2.0 is fully
aligned and allows uploading the information you have in
v1.0 (most will be supporting documentation).
• Don’t wait, FDA expecting you to have in place. Larger
facilities can expect a “Quick Check” at any time now,
and small businesses can expect a “Quick Check”
beginning in March, 2021.
• 10 “Quick Check” inspections will begin.

21. FSMA FRIDAYS
FDA Inspection Strategy
• Two-Tiered Inspectional Approach*
■ Food Defense Plan Quick-Check
• Conducted on all covered facilities
• Very low burden on agency and industry
• Very little required training for investigators
■ Food Defense Comprehensive Inspection
• Conducted only on a limited number of prioritized
facilities
• Focus inspectional resources on where IA concern is
highest
• Specialized training for investigators

22. FSMA FRIDAYS
Potential Quick Check Questions
• Do you have a written Food Defense Plan?
• Was it written by an FDQI?
• Did you conduct a Vulnerability Assessment?
• Have you identified any KAT’s?
• Did you choose the option of using the “3 Key Element” approach?
• Have you considered the possibility of an inside attacker?
• Have you implemented any mitigation strategies?
• Has it been signed and dated by the FDQI?
• Do you have Corrective Actions in place?
• How are you verifying?
• Have you had a Food Defense Incident?
• If so, did you contact the FBI?
Download infographic at:
safetychain.com/quick-checks

23. Q & A
FSMA FRIDAY

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Resources & Future Events
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September 25, 2020:
New Canadian Nutrition Labelling with Cameron Prince