1. Food Defense Plan
Bryan T. Granger
Vice President, Compliance,
Government Relations and Real Estate
C&S Wholesale Grocers, Inc.

2. Food Safety Modernization Act (“FSMA”)
• Prior to passage of FSMA, FDA had no requirements for food facilities to
implement mitigation strategies or measures to protect against
intentional contamination.
• FDA produced general guidance and resources for industry on food
defense. The guidance represents the agency’s current thinking on the
measures that food establishments may take to minimize the risk that
food under their control will be subject to intentional contamination. For
more information on the guidance, tools, and resources available to
industry, visit the FDA Website.
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3. Food Safety Modernization Act
Section 103. Hazard Analysis and Risk Based Preventative Controls
• Identify and evaluate hazards that may be intentionally introduced (acts
of terrorism);
• Implement preventative controls to prevent hazards;
• Monitor controls and maintain monitoring records;
• Conduct verification activities; and
• Provision applies to facilities that are registered with the FDA.
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4. Food Safety Modernization Act
Section 105. Standards for Produce Safety
• Establish science-based, minimum standards for the safe production
and harvesting of fruits and vegetables
• Applies to entities engaging in the harvesting and production of such
commodities
• Must consider hazards that occur naturally, may be unintentionally
introduced, or may be intentionally introduced (acts of terrorism)
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5. Food Safety Modernization Act
Section 106. Protection against Intentional Adulteration
• Issue regulations and guidance to protect against the intentional
adulteration of food
• Conduct vulnerability assessments of the food supply and determine
mitigation strategies
• Applies to Facilities that are registered with the FDA.
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6. What is a Food Defense Plan (FDP)
Food Defense Defined.
• The concept of Food Defense is defined as establishing controls that
reduce the chances of the food supply from becoming intentionally
contaminated by means of a variety of chemicals, biological agents or
other harmful substances by people who want to do us harm.
• Food Defense is not the same as food safety. Food safety addresses
the unintentional contamination of food products by agents
reasonably likely to occur in food supply (e.g., E. coli, Salmonella,
Listeria).
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7. USDA FSIS
In 2004 FSIS Proposed Rule for Food Defense Plans:
• Federal establishments required to develop, implement and maintain
plans to prevent intentional contamination
• Plans to be reviewed annually and modified as appropriate
In response, industry proposed FSIS allow voluntary adoption of food
defense plans:
• Industry to work collaboratively with government to achieve goal of food
protection, assist with outreach
• FSIS to provide industry with tool they need for food defense. Recent
tools include the General Food Defense Plan, web-based FSIS Food
Defense Risk Mitigation Tool
FSIS will consider requiring food defense plans (make rulemaking
a priority) if voluntary adoption is unsuccessful
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8. 2011 Food Defense Plan Survey Results
The sixth food defense plan survey was conducted in July 2011. The types of
facilities included meat and poultry slaughter and processing establishments,
processed egg products plants, and official import inspection establishments.
Overall, 75% of all establishments surveyed have a functional food defense
plan (up from 74% in 2010).
In 2010, USDA made the voluntary adoption of food defense plans a
performance objective. The target is for 90% of establishments to have a
functional food defense plan by 2015.
July 2011 Food Defense Plan Survey Results
Establishme
nt
Size
Percent of Establishments with a Functional Food Defense Plan
Processed Egg Products Plants
Import Inspection Establishments
Overall
96%
100%
(none)
96%
84%
Large
Meat & Poultry Establishments
92%
57%
84%
64%
78%
82%
65%
75%
93%
78%
75%
Small
Very Small
Total
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9. Basic Food Defense Program Considerations
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External Physical Security measures
Internal Process Control Security measures
Personnel security measures
Product and supply security measures
Crisis management response security measures
Internal and eternal communication programs
Maintenance of Consumer/Customer confidence
Qualifying crisis event facts to support critical corporate decisions
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10. Overarching Goals for Food Defense
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Know who is in your facility at all times and reasonably control their access
Identify the vulnerabilities in your operation, determine the levels of risk and
mitigate
Investigate, report and mitigate any breaches of security or food defense
measures
Develop policies, procedures, training to support your food defense
measures and plan
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11. USDA Guidelines
USDA Food Safety and Inspection Service Guide – presents a plan on how to
implement a Food Defense Plan.
• Step One - Conduct a Food Defense Assessment
• Work with security team to determine vulnerabilities of the warehouse
• Look at Outside Security, Inside Security, General Security, Shipping
and Receiving Security, Mail Handling Security, Personnel Security
• Step Two – Develop a Food Defense Plan
• Identify the most cost effective preventative actions that can be taken
to minimize identified vulnerabilities
• Step Three – Implement the Food Defense Plan
• Designate person to implement, manage plan
• Train personnel in food defense
• Assign responsibilities
• Assess and Revise plan as needed
• Review Product Recall Procedures to contemplate update to address
food defense concerns
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12. Purpose of the C&S FDP
The C&S Food Defense Plan:
•
Details the framework by which C&S identifies and verifies the controls
established toward minimizing the risk of intentional food product
contamination or tampering.
•
C&S implemented its Food Defense Plan in conjunction with USDA
guidelines and in preparation for FSMA regulations.
•
C&S leveraged existing resources at all levels of the organization to develop
a robust program.
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13. C&S Corporate Food Defense Committee
• Corporate Food Defense Committee is responsible for determining
vulnerability and consequent actions necessary to address gaps in the food
defense assessment matrix. The completed food defense assessment
matrix considers both potential internal and external threats.
• Following disciplines are represented: Risk Management, Compliance,
Security, Operations, Environmental Health and Safety, Environmental
Compliance, Food Safety, and Regulatory Compliance.
• The Committee reviews the Food Defense Plan at least annually or as
required, to ensure ongoing effectiveness throughout the organization.
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14. C&S Consideration of FSMA
The Corporate Food Defense Committee:
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Conducted evaluations to identify “known or reasonably foreseeable
hazards,” including hazards that “may be intentionally introduced,
including by acts of terrorism”.
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Identified processes and consequent actions that reside within existing
Corporate Programs that provide preventive controls that assure the
identified hazards would be significantly minimized or prevented.
•
Required monitoring of these controls is ongoing. The establishment of
corrective actions, maintenance of monitoring records, instances of
nonconformance, and corrective actions are the responsibility of the
individual Corporate Program Department Owner.
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15. Food Defense Plan Matrix
The Food Defense Plan Matrix is made up of 4 sections, with each one detailing
existing process’s and actions that are done, and notes which corporate
department owns it.
The Food Defense Plan Matrix identifies both potential internal and external
threats, and makes departments accountable for following procedures to mitigate
those threats.
The 4 sections are as follows:
• Outside Security
• General Inside Security
• Shipping and Receiving Security
• Personnel Security
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16. Food Defense Plan Matrix
Outside Security- Food Defense measures for the exterior of building.
Accountable Departments: Corporate Security and Food Safety
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Having controlled or guarded entrances.
Facility’s grounds are secure to prevent entry by unauthorized persons.
These include fences, gates, guard service, etc.
Locations secured with locks, seals, or sensors when unattended such as
windows, loading dock doors, roof openings.
Procedures in place for people and/or vehicles entering the facility.
(Logging of visitors names, vehicles, license plates and reason for visiting;
Badge system for identification purposes. Car trunk inspections.)
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17. Food Defense Plan Matrix
General Inside Security:
Accountable Departments: Corporate EHS, Corporate Security, Maintenance,
Environmental Compliance
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Emergency alert systems and lighting, security camera’s, and visitor
restrictions within the facility.
•
Storage of hazardous materials such as industrial chemicals, cleaning
materials and disinfectants. Disposition of hazardous chemicals is also
covered.
Shipping and Receiving Security:
Accountable Departments: Corporate Security, Transportation, Warehouse
Operations, Food Safety, Receiving, A/P
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Inbound trailer seal programs, Guard shack sop’s, Bill of Lading review,
Delivery logs, Yard Mgt systems (YMS), Store returns.
Outbound trailer seal programs, Gate pass procedure, shipping document
verification.
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18. Food Defense Plan Matrix
Personnel Security:
Accountable Departments: Corporate Food Safety, Security, Human
Resources, Warehouse Operations
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Employee training on security procedures at orientation;
Employees, visitors, contractors, badge ID/entry procedures;
Updated shift rosters;
Visitors and contractor car inspections when entering/leaving
facility.
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19. Food Defense Plan Matrix
Corporate Dept
Requirement
Owner
Outside Security
1. Food defense measures in place for the exterior of the building.
Dept Document
Are the facility’s grounds secured to prevent entry by
unauthorized persons (e.g., by locked fence, gate or
entry/exit doors, guard service)?
Corp Security
Corp Food Safety
Physical Security Audit- Sec 1
FSA (Q3.02)
Is there enough lighting outside the building to properly
monitor the warehouse at night/early morning?
Corp Security
Corp Food Safety
Physical Security Audit- Sec 1A
FSA (Q3.10)
Do emergency exits have self-locking doors and/or alarms?
Corp Security
Corp Food Safety
Physical Security Audit- Sec 2
FSA (Q3.08)
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20. Food Defense Plan
C&S Auditing Measures
• Include assessment of Training on Food Defense Plan in Monthly Facility
Self Audits
• Aspects of Food Defense Plan are audited through other departments, for
instance, the Security Department will perform regular audits which include
looking at the surveillance requirements of the Food Defense Plan
• Internal Audit will perform assessments of Food Defense Plan as part of
regular warehouse audits
Inspections
• Performed by FSIS or State Department of Health
• In general, no comment or positive feedback on plan
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21. FSIS Inspections
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Is there a written Food Defense
Plan?
Is there an Inside Surveillance
System?
Is access to receiving and shipping
areas restricted?
Is there a procedure to verify that
incoming/shipped products are
consistent with shipping
documents?
Is there a procedure to observe
incoming products for indication of
tampering?
Where all products observed free
from apparent tampering or
adulteration?
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22. Food Safety Modernization Act
•
Resources for updates
– http://www.fda.gov/Food/FoodSafety/FSMA/default.htm (to receive
updates)
– Food Defense FAQs online
– Submit any questions you may have to FSMA@fda.hhs.gov
– Website: www.fda.gove/Food/FoodDefense/default.htm
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23. Food Defense Plan
Questions or Comments ?
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