Join special guest Rod Wheeler, CEO of The Global Food Defense Institute, as he clarifies FSMA’s IA rule requirements and serves up tools that help large food manufacturers and processors identify their vulnerabilities in two days or less. Food companies will gain a clear understanding of IA compliance requirements and the knowledge they need to write their food security and defense plans including: - How to conduct your own vulnerability assessment in 2 days or less - Using the FDA’s Food Defense Mitigation Strategies database...It’s easy! - What security countermeasures are available to consider to mitigate the risk of intentional tampering at a food plant - Using your vulnerability assessment to help build your Food Defense Plans About the Presenter, Rod Wheeler Rod Wheeler Global Food Defense Institute Rod Wheeler is the Founder and CEO of The Global Food Defense Institute, the only global firm that focuses solely on food defense, intentional adulteration (IA), tampering, and intelligence. As a former Crime Analyst for the Fox News Channel and frequent guest on several national and international news outlets, he is a leading expert on food security, terrorism and crime.

1. Title: FSMA’s IA Rule: Are You Ready?
Presented By: Presented By: Rod Wheeler, The Global Food Defense Institute
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5. TRAINIG TOPIC
Presented By: Rod Wheeler
Founder and CEO, The Global Food Defense Institute
Food Defense & Homeland Security Expert
Former DC Police Homicide Detective
National News Media Crime & Law Enforcement Analyst
FSMA’s IA Rule: Are You Ready?
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6. OBJECTIVES
• Understand FSMA’s IA Rule Beyond Compliance Webinar Series
WHAT THE FSMA
INTENTIONAL
ADULTERATION RULE
REQUIRES
KEY ACTIVITY TYPE
AREAS
DEVELOPING
REDZONES
7 SPECIFIC AREAS TO FOCUS ON FOR
YOUR FACILITY VULNERABILITY
ASSESSMENT.
CONVERT YOUR ASSESSMENT TO
YOUR FOOD DEFENSE PLAN

7. Understand that there is a correlation
between product tampering and
sabotage, and workplace violence
Train your managers how to look for
warning signs of a potential aggressor
and how to safely terminate an
employee who may become hostile or
violent
Conduct Active Shooter/Threat drills
and training for all of your plant
employee’s
Quick Tips and Suggestions
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8. “Think Like a Criminal”
Step one in Conducting Your Food
Defense Assessment:
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9. FSMA Intentional
Adulteration Rule
What’s required?
The Global Food Defense Institute
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10. United States FBI
External Threats
“Violent extremists and terrorists
consider America’s agriculture and
food production tempting targets!”

11. Insider threats/Disgruntled Employee,
Contractor or Visitor

12. Food Defense focuses on
protecting the food supply from
intentional contamination.
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13. FDA Focuses on three primary forms of
Intentional Adulteration
Acts of Terrorism against the Food and
agricultural Supply.
Disgruntled Employees
Economically Motivation Adulteration
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14. Actionable Process Step
A point, step or procedure in a food process at which food defense measures can be applied and are essential to
prevent or eliminate a significant vulnerability or reduce such vulnerability to an acceptable level .
Site Specific
Identified by the vulnerability assessment
Think of HACCP!
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15. Rule Requirements of Food Facilities
Prepare and implement a written food defense plan
Have conducted a security vulnerability and risk assessment
Provide security awareness training for its employee’s
Develop “actionable process steps,” mitigation strategies,
procedures for monitoring, corrective actions and verification.
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16. FDA FSMA Mitigation
Strategies Database
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17. Written into law in
January of 2011
Full compliance by 2nd
Qtr. of 2019
Prevention
Increased Inspections by
the FDA and Third Party
Auditors
Import of food safety Enhanced Partnerships
Concern about food that
“presents a threat of
Serious Adverse Health
Consequences or Death
to Humans or Animals”
(“SAHCODHA”)
Corresponds to standard
for Class I recall
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18. Monitoring: Establishing
and implementing
procedures that monitors
the mitigation strategies
1
Corrective actions: The
response if mitigation
strategies are not
properly implemented.
2
Verification: Ensure that
monitoring is being
conducted and
appropriate decisions
about corrective actions
are being made.
3
Training and
recordkeeping: personnel
assigned to the vulnerable
areas receive appropriate
training; facilities must
maintain records for food
defense monitoring,
corrective actions, and
verification activities.
4
FSMA/I.A. Rule Requirements
Beyond Compliance Webinar Series

19. Significant Vulnerability
FDA-A vulnerability for which a prudent person knowledgeable about
food defense would employ food defense measures because of the
potential for serious health adverse consequences (SACOHDA) and the
degree of accessibility to that point in the food process
Can occur at a particular point in the process
FDA”-Hazard that is reasonably likely to occur”
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20. Begin your assessment-
Review the following:
Video/CCTV Signage Lighting
Locks, lockers and Key
control
Alarm system testing and
operation
Visitor control
Security guard force
operations
Inventory control and
accountability
Background checks and
screening procedures
Contractor screening and
controls
Emergency evacuation
procedures and mock drill
review
Mail, bomb threat and
package handling
procedures and controls
Emergency crisis planning
and response including
Active Shooter Response
Workplace violence
procedures and response
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21. What personnel should be involved in conducting the assessment?
Key Staff members on all shifts (security, safety, H.R. , Legal, Operations, Quality, Engineering,
shipping/receiving, warehouse, finance, etc.)
Observing the facility functioning at various hours covering all shifts. This includes night time
observations.
Interviewing and establishing relations with local, state and federal law enforcement and regulatory
agencies. This also includes visiting and meeting with local emergency personnel and hospitals in the
area.
Reviewing relevant crime reports, post orders for security personnel, building blueprints/plans, crisis
plans, etc.
Evaluating existing or planned security countermeasures including assisting with the development of
a CCTV program in which cameras are strategically placed.
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22. Conducting the
assessment:
The “walk-a-round”
1. The food defense team should meet in a conference room. A Vulnerability
Assessment Leader should be identified. It is recommended that this person has
been certified by the Global Food Defense Institute.
2. Review the FDA or the GFDI Food Defense Assessment Questionnaire and Plan
Builder.
3. Divide into teams of 2, 3 or 4 persons to conduct the assessment in the various areas
as described by the assessment questionaire.
4. Divide the sections of the questionnaire amongst the teams evenly.
5. Began to answer each question in detail, providing recommendations to the other
team members once the team regroups.
6. It is recommended to allow anywhere from 6 hours to 2 days to complete the
assessment, depending on the size (square footage and number of employee s) at
your facility. You can also use the information from your vulnerability assessment
as part of your food defense plan.
7. Review the building schematics…outside and inside areas before beginning the
walk-a-round to develop a walking/observation route plan.
8. Generally, start on the outside of your facility in the front, surveying areas around
your plant, and gradually working to the inside areas in order to complete the
assessment. During the assessment, be sure to indicate which areas should be
considered REDZONES, and also, where cameras and card access devices should be
placed.
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23. 7 Specific Areas to
focus on for your
assessment
The Global Food Defense Institute
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24. #1 Key Activity
Types (KAT)
The Global Food Defense Institute
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25. With each KAT and while conducting your assessment,
consider the following when looking at each area..(Critical)
1. Accessibility or ease of
access to the areas of each
of the activity types;
2. Vulnerability of
contamination or
interference of the process
or ingredients of the activity
type;
3. Criticality of harm to
persons, assets or brand if
the key activity type is
intentionally compromised.

26. Key Activity Type
Bulk Liquid Receiving and Holding
A step in which a bulk liquid is received
and unloaded from an inbound
conveyance or loaded into an outbound
conveyance where a contaminant can be
intentionally introduced and if it is, it is
likely that the contaminant will be
distributed throughout the liquid due to
sloshing, movement, or turbulence caused
by receiving and unloading or loading
activity.
Let’s go to:
FDA Food Defense Strategies Database
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27. Key Activity Type
Liquid Storage & Handling
Where liquid is contained in bulk
storage tanks or in holding,
surge, or metering tanks where a
contaminant could have been
intentionally introduced and if it
is, the contaminant could
potentially be distributed in the
food supply.
Let’s go to:
FDA Food Defense Strategies
Database
Beyond Compliance Webinar Series

28. Key Activity Type
Secondary Ingredient Handling
Staging areas, preparation
areas, or a rework step
where a contaminant could
be intentionally introduced
into the product and
eventually distributed into
the food supply.
Let’s Go To:
FDA Food Defense Strategies
Database
Beyond Compliance Webinar Series

29. Key Activity Type
Mixing and Similar Activities
Mixing Rooms, Blending,
homogenizing and grinding
areas where a contaminant
could be intentionally
introduced into the product
and eventually distributed
into the food supply.
Let’s go to:
FDA Food Defense Strategies
Database
Beyond Compliance Webinar Series

30. What is a
Red/Restricted
Zone?
Focused Security Screening and Inspection before being granted
entry into key and critical areas of a food plant;
Increased vetting of employees who will be working in the key and
critical areas of a plant as identified by the Vulnerability Assessment.
Internal Controls and 100% Auditing of Plant-Issued Credentials;
Risk-Based Food Defense for High Risk Products/Processes as
Identified by the Vulnerability Assessment and intelligence.
Increased on-going Security Awareness and Vigilance.
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31. Develop REDZONES for
each Key Activity Type

32. #2 Review of Food Defense Programs
Food Defense
Plans
Facility parking
program policies
Facility access
control policies
Last vulnerability
assessment results
Employee locker
policy
Employee internet
usage policy
Contractor, visitor
and other guest
access policy for
your facility
Security incident
reports
Original visitor log
in registration
book or sheets
Evacuation policy
for all types of
emergencies
Documented
uniform policy for
employees
Chemical control
log from the
laboratory if
applicable
Policy for truck
driver access
Seal policy with regards to applying
and removing seals on incoming and
outgoing shipments
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33. #3 Outside Security Measures
Establish a perimeter around the
property
• Physical barriers to prevent unauthorized entry
• Fencing, vegetation, barriers, signage
“No Trespassing” signs should be
posted at appropriate intervals
Integrity of the plant perimeter
should be monitored for signs of
suspicious activity or unauthorized
entry.
Outside lighting should be
sufficient to allow detection of
unusual activities.
• Lighting should be at appropriate levels
• Outside storage vessels or buildings
• Parking lots and walk-ways
• Support CCTV systems
All security lighting should be
photo-electric sensors
Lighting should be part of PM
program and checked periodically
• Use of light meters
• Number all light units and map
Doors, windows, roof openings,
vent openings, trailer bodies,
railcars and bulk storage tanks
should be secured
(i.e., locks, seals, sensors) at all
times.
Emergency exits should be alarmed
and have self-locking doors that
can be opened only from the
inside.
• All perimeter doors should be numbered on
inside and outside of door
• Remove exterior hardware from these doors
• Ensure hinge pins are properly secured
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34. #4 Inside Security Measures
Lobbies should be protected
• Access Control
• Visitor sign-in logs
• Identification checks and verification with
contact person
• Visitor badges
• Panic or distress buttons for receptionist
• Review visitor logs at end of day
Inspection of personal belongings
Provide security and other
appropriate rules for visitors
Visitors, guests and other non-
plant employees (contractors,
salespeople, truck drivers, etc.)
should be restricted to
nonproductive areas unless
accompanied by an authorized
plant representative.
Colored smocks, bump caps,
badges, etc.
Computer data systems should be
protected using passwords,
network firewalls and effective and
current virus detection systems.
What are the visitor polices for
computers brought into the
facility?
Restricted areas inside the plant
should be clearly marked and
secured.
Access to central controls for
airflow, water systems, electricity
and gas should be restricted and
controlled.
Updated plant layout schematics
should be available at strategic and
secured locations in the plant.
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35. #5 Materials Receiving/Loading Security
Are product and ingredient
suppliers required to provide
evidence of food defense
programs?
Are supplier (continuing)
guarantees on file for all
ingredients and packaging?
Is a formalized ingredient and
packaging testing program in
place to observe suspicious or
adulterated products? (in-
house testing, outside testing,
or certificates of analysis).
Does the facility receive Bulk
Materials? ( Ingredients,
Chemicals, Gases, Etc. )
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36. #6 Facility Operations: Labels, seals, CCTV, physical barriers, etc.
Are air supply systems into
facility inspected and/or
tested on a regular basis?
Are access control, CCTV
monitoring, and/or peer
monitoring present at key
manufacturing or storage
locations?
Is access to bulk ingredient,
gas, or chemical storage
vessels controlled to limit
unauthorized access to
hatches, filters, vents, etc?
Are physical barriers in place
and/or access restricted to
hazardous compounds such as
nitrite, cleaning and sanitizing
chemicals, maintenance
chemicals, pesticides, etc?
Are controls in place to
prevent intentional
contamination by contractors
of maintenance, pest control,
or sanitation crews?
(RedZones)
Is a process in place to identify
any sampled or opened
ingredient containers?(
Employees awareness
programs)
Is traceability provided for all
ingredients, direct contact
packaging and rework?
Is access to food safety
manufacturing components
limited and controlled? (retort
controls, pasteurizer controls,
heat control components,
etc.).
Are food safety detection
devices monitored and
inspected on a regular
frequency to ensure proper
function?
Is tamper-resistant/evident
packaging and/or seals
provided for finished goods?
Do all finished goods have
appropriate lot identification?
Are product labels held in
secure area and accounted
for?
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37. #7 Shipping/Product Storage
Are finished goods
appropriately segregated
from raw materials or
hazardous chemicals?
Are written procedures
established for inspection
of all vehicles prior to
loading (bulk and non-
bulk)?
Are inspections conducted
of all outbound vehicles
prior to loading?
Are wash certificates
and/or seals verified with
trailers.
Is mail handled away from
food, including
ingredients and packaged
food products?
Are all amounts and lot
numbers of materials
verified during loading?
Is the Security of trucks
and trailers maintained
during transport and
multiple stops or
deliveries?
Does Shipping documents
contain lot and seal
numbers for outgoing
shipments?
Are all shipment
documentation and
records kept on file?
Are all outbound products
listed on a bill of lading?
Are all Loading docks and
doors locked and secured
when not in active use?
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38. Completing Your
Food Defense Plan
The Global Food Defense Institute

39. FDA Food Defense
Plan Builder
GFDI Food Defense
and Emergency
Readiness Plan
Builder (REDi)
Additional Material needed for plans:
Emergency Contact List (Corporate & Local
Facility)
Supplier Emergency Contact Information
Building Schematics including evacuation
plan for various types of emergencies
Local Gov’t contacts: Police, Fire, EMS,
Dept. of Health, etc.
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40. z
Food Defense Plan Builder
FDA Food Defense Plan
Builder
GFDI Food Defense Plan &
Training (REDI)
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41. Global Food Defense Training and Assessments Services-Contact Us: 202-368-3007 or email: info@myfooddefense.com

42. Upcoming Food Defense Public Courses
Food Defense, Crisis Mgt., Intentional
Adulteration & Active Shooter Readiness
-Orlando Fla.
February 27th-28th, 2019
9:00 am - 5:00pm
Fee: $895.00
Click here for details/registration
Food Defense, Crisis Mgt., Intentional Adulteration & Active Shooter
Readiness
-Milwaukee, Wisconsin
April 9th-10th
October 1st-2nd, 2019
9:00 am - 5:00pm
Fee: $1195.00
Click here for details/registration
Food Defense, Crisis Mgt., Intentional
Adulteration & Active Shooter Readiness
-New Orleans, La.
May 13th-14th, 2019
9:00 am - 5:00pm
Fee: $895.00
Click here for details/registration

43. THANK YOU!
Global Food Defense Institute
www.myfooddefense.com
(202) 368.3007

44. Q & A

45. Resources
White Papers & Surveys
Webinars & Videos
Product & Partner Info
Solution Consultation
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