In addition to recapping May, 2019 FSMA news and changes, Rolando González and Chris Snabes from TAG dive into Food Defense and the recent messages conveyed by the FDA that have us asking many questions.

1. FSMA FRIDAYS
The Latest Industry News, Updates & Trends
May 2019

2. MONTHLY INDUSTRY UPDATE
üFSMA Related News
üRegulation Changes & Updates
üIndustry Trends
üQ&A with TAG
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4. FSMA FRIDAYS
Agenda
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WHAT WE WILL COVER
üFSMA Update
üCrash Course in Food Defense & IA Rule
üAudience Q&A

5. Presenters
Brian Sharp
President
Christopher Snabes, MS
Senior Manager, Food Safety at The Acheson Group
• 17+ years food industry experience
• Degrees in microbiology and biology
• One of very few authorized Lead Instructors for the Vulnerability Analysis component of food defense plans
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Rolando González, Ph.D.
Vice President of Public Health at The Acheson Group
• 15+ years food industry experience including technical and senior roles at Target, Buhler AG and 3M
Food Safety.
• Degrees include Bachelors in Microbiology and PhD in Food Science and Public Health
Brian Sharp
President, SafetyChain

6. FSMA NEWS
Latest FSMA Updates
• 4/17/2019 - Public Meeting on the Draft
Guidance to Support Compliance with the
Intentional Adulteration Rule
• 5/16/2019 - FDA Extends Application Period
for Voluntary Qualified Importer Program to
July 31

7. FSMA FOCUS
The FSMA Food Defense Plan:
FDA Expectations on Training and
Options on Writing a Food Defense Plan

8. 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
• Food Defense Plans must be written by July 26, 2019 for the largest
facilities
• The Food Defense Plan is site/facility specific
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9. 9
Vulnerability
Assessment
Mitigation
Strategies
Monitoring
Corrective
Actions
Verification
Reanalysis
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
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10. Types of Food Defense Training via FSPCA and
becoming a “Qualified Individual”
• Food Defense Awareness Training. Requirement for all employees (satisfies
121.4 (b)(2)). Free on-line course is available.
• Overview of the Intentional Adulteration Rule. Free on-line 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.
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11. 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 one
VA LI). This is a fee based course, and comes with a certificate of training.
KAT training is STRONGLY encouraged prior to taking this course.
• Can establish you are trained without FSPCA courses via education and/or
on the job training as long as it is documented.
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12. 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
• Conduct Initial Vulnerability Assessment – determine your KATs:
• Bulk Liquid Receiving and Loading
• Liquid Storage and Handling
• Secondary Ingredient Handling
• Mixing and Similar Activities
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13. 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.
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14. 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 pre-determined
scale (you can use an internal scale if there is written justification
• Assesses each step to determine if it is a KAT that will be a potential APS
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15. The Three Elements
• Element 1 (Criticality): Potential public health impact (e.g., severity and
scale) if a 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): Degree of physical access to the product
• Element 3 (Vulnerability): Ability of an attacker to successfully
contaminate the product
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16. Pro’s and Con’s 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.
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17. 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
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18. Next Steps
• Current Food Defense Plan Builder, v1.0, not aligned with IA Rule. v2.0 will be fully aligned
and allow uploading the information you have in v1.0 (most will be supporting
documentation). Expected release date late Summer, Early Fall 2019.
• FSPCA Training on Food Defense Plan Writing and Reanalysis forthcoming, soon….
• Third Guidance Document of Food Defense, forthcoming, soon….
• All of the above are being released independently of each other, and can be released in
any order.
• Don’t wait, FDA expecting you to have in place even though not being enforced until
March 2020.
• 10 quick step inspections for approximately two years...
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19. Q & A

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