52 Paterson Ave Unit#1

Newton, NJ 07860
United States

Food Defense

Purpose

The purpose of this policy is to outline the methods in place to communicate the food defense
program. This program ensures compliance with certification standards, customer expectations,
and regulatory requirements outlined in 21 CFR 121: Mitigation Strategies to Protect Food
Against Intentional Adulteration.

Policy

GC and Partners ensure that all facilities housing product develop and maintain a
comprehensive, FDA-compliant, food defense plan with the aim of mitigating food safety risks
associated with intentional contamination. Many food defense requirements are included in
separate prerequisite programs and referenced below.

Training: Facilities designate an individual to oversee the routine maintenance of the

vulnerability assessments, mitigation strategies, and reanalysis. Personnel given authority over
a facility’s food defense plan receives formal training through the FDA Food Defense 101
program at a minimum. This training in combination with job experience meets FDA
requirements for a Qualified Individual.

Vulnerability Assessment: Vulnerability assessments are conducted for all facilities as part of
the FDA Food Defense Plan Builder. Areas deemed as potentially vulnerable are areas where
final products are handled and stored and all cGMP areas.

Food Defense Plan General Practices, Mitigation Strategies, and Monitoring: Partner facilities
develop food defense plans using the FDA- provided Food Defense Plan Builder. The builder is
available here: https://www.fda.gov/food/food-defense-tools-educational-
materials/food-defense-plan-builder. Mitigation strategies include broad mitigation strategies
and focused mitigation strategies.

Quality Assurance Team

Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.
 52 Paterson Ave Unit#1
Newton, NJ 07860
United States

Broad Mitigation Strategies: Broad Mitigation Strategies are measures that facilities may take to
minimize the risk of intentional contamination.

Visitor Log & Identification: Facilities meet the requirements of Policy

Visitors by controlling visitor access, identifying, and documenting visitors. Visitor log monitoring
is conducted according to scheduled internal audits.

Employee Training: Facilities train employees on food defense- related information per Policy

Employee Food Safety & Quality Training. Key elements include site security, visitor
identification, and reporting suspicious activity. Employee training is monitored according to
scheduled internal audits.

Surveillance Technology in Vulnerable Areas: Packaging or loading areas that are not protected
by equipment guarding, e.g., tote filling station, bulk loading facilities, bulk unloading facilities,
and silo access points are monitored by digital CCTV surveillance cameras. Facilities ensure
that coverage is adequate and effective to monitor access points and equipment can retain
data/images for a minimum of three months. Facilities should also develop a map of
surveillance locations. Surveillance coverage is monitored during scheduled internal audits.

Chemical Storage: Facilities store hazardous chemicals away from product handling or product
storage areas and ensure those areas are secured or restricted according to Policy 5.17

Chemical Control and Approval. Chemical storage is monitored during routine facility
inspections and scheduled internal audits.

Restricted Laboratory Access: Facilities with on-site labs ensure that labs are restricted to
authorized personnel only.

Computer System Security: Computer systems access must be controlled to authorized

personnel or password protected.
Quality Assurance Team
Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.
 52 Paterson Ave Unit#1
Newton, NJ 07860
United States

Focused Mitigation Strategies: Focused Mitigation Strategies are science- based procedures,
practices, or processes that, when employed at specific process steps, may minimize the
vulnerabilities identified during the vulnerability assessment. The following have been identified
and should be implemented at applicable facilities:

Incoming Material Inspections: Facilities inspect each shipment incoming materials (packaging,
processing aids, and food) to ensure that: first, materials are sourced from approved suppliers;
second, materials arrive sealed and seal numbers match incoming documentation; third,
incoming materials are inspected for contamination, damage, and tampering. These
requirements and material types are outlined in Policy

Supplier Approval. Verification of incoming inspections is conducted according to scheduled

internal audits.

Secured Access: Facilities control access to warehouses, bulk storage, and packaging areas by
securing those areas via keyed entry, keypads, or keycards. Facilities monitor secured areas
during routine facility inspections (monthly) and scheduled internal audits.

Bulk Tank/Storage Entry Points: Facilities secure exterior bulk storage facilities with
numbered seals or padlocks.

Tote Seals: Facilities producing totes employ numbered, plastic seals for each tote.
Conveyance Seals: Conveyances include bulk trucks, dry van trucks, bulk rail, containers, and
boxcars and must be secured with numbered cable seals at least 1/8” or larger. In cases where
customers require larger seals (3/16”), requirements are communicated in the notes of the work
order. Seal numbers must be documented on or accompany the bill of lading.

Mitigation Strategy Monitoring/Testing & Corrective Actions: Mitigation strategies are

monitored/tested during monthly facility inspections and internal audits at a minimum. At any
time if a mitigation strategy is found deficient, facilities implement corrective actions in
accordance with Policy
Quality Assurance Team
Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.
 52 Paterson Ave Unit#1
Newton, NJ 07860
United States

Corrective Action & Root Cause Analysis.

Reanalysis: Facilities perform reanalysis of food defense plans annually to meet the
management review requirements outlined in Policy 1.5 Food Safety & Quality System Review
or when the plan is found to be deficient. The Quality Assurance Team reviews the base
requirements outlined in the policy annually.

Responsibility

Quality Assurance Team: Responsible for interpretation of FDA law, certification standards, and
their application to Company policies. Responsible for the contents of this policy and for
annually reviewing basic FDA compliance requirements.

Warehouse Managers / General Managers: Responsible for overseeing the local development
of the food defense plan in the FDA food defense plan.

Quality Assurance Team

Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.