Food Defense - Mitigation

Strategies To Protect Food

Against Intentional
Adulteration
Dr. Bob Strong
June 20, 2016

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Our Presenter Today

Dr. Bob Strong

– Senior Consultant – SAI Global Assurance Services
– Driving force behind our food safety operations in the
areas of Good Manufacturing Practice (cGMP) and
supplier assurance programs (GFSI), including SQF,
BRC and FSSC 22000.
− 45 years of experience in the food industry, while working for national
and international companies in quality assurance, product development
and auditing. He is an often requested seminar speaker in the areas of
GMP, HACCP and HARPC.
− Ph.D. and BSC in Chemistry and an accomplished food safety trainer
for numerous food safety manager certification courses
− In addition, he is a GMP/HACCP/HARPC instructor, a Lead Auditor
trainer, and is also certified to consult on the Global Food Safety
Initiative. He is certified in 21 SQF product categories

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Agenda

• Exempted Businesses
• Mitigation Strategies as a part of FSMA
• Contents of a Food Defense Plan
1. Vulnerability Assessments (Qualified Individuals).
2. Actionable Process Steps
3. Focused Mitigation Strategies (Qualified Individuals).
4. Monitoring
5. Corrective Actions
6. Verification
• Recordkeeping
• Effective and Implementation Dates

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 Exempted Businesses

This requirement applies to all facilities that are required to

register with the FDA as a Qualified Business with the
exception of the following facilities:

• Farms, except if they produce milk.

• Very small businesses with <$10,000,000 in sales.
• Storage facilities that store packaged food that is not
exposed;
(Not exempt if they hold liquid in bulk tanks).
• Facilities that re-pack, re-label foods as long as the
food is not exposed.
• Alcohol manufacturers.
• Animal Food manufacturers and distributors.
Food Safety Modernization Act (FSMA) 2010

• Title 1 Designed to improve capacity to prevent food safety problems

• Title 2 Designed to improve capacity to detect and respond to food

safety problems

• Title 3 Designed to improve the safety of imported food

• Title 4 Includes miscellaneous provisions

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Title 1 Sections -
Designed to prevent food safety problems

• Section 101 FDA access to your records

• Section 102 Registration and possible suspension by FDA
• Section 103 Preventive Controls for Human Foods
• Section 104 FDA hazard information
• Section 105 Produce food safety guidelines
• Section 106 Regulations to prevent intentional adulteration
• Section 107 Fee assessments by FDA
• Section 108 National agriculture and food defense strategy

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 FSMA Section 103
Preventive Controls for Human food

• Sec. 103 of the Food Safety Modernization Act describes Preventive

Controls for Human Food in the following way:

“The owner, operator, or agent in charge of a facility shall, in accordance with

this section, evaluate the hazards that could affect food manufactured,
processed, packed, or held by such facility, identify and implement
preventive controls to significantly minimize or prevent the occurrence of
such hazards and provide assurances that such food is not adulterated
under section 402 or misbranded under section 403(w), monitor the
performance of those controls, and maintain records of this monitoring as a
matter of routine practice.

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 cGMPs 21 CFR 117 Subpart C
Hazard Analysis and Risk-Based Preventive Controls

• 117.126 Food Safety Plan • 117.150 Corrective actions and

corrections
• 117.130 Hazard Analysis
• 117.155 Verification
• 117.135 Preventive Controls
• 117.160 Validation
• 117.136 Preventive Controls
exemptions • 117.165 Verification of
implementation and effectiveness
• 117.137 Assurances required
for exemption • 117.170 Reanalysis
• 117.39 Recall Plan • 117.180 Requirements applicable
to preventive controls qualified
• 117.140 Preventive control
individual and a qualified auditor
management components
• 117.180 Implementation records
• 117.145 Monitoring
required for this subpart
 117.130(b) Hazard Identification

• Known or reasonably foreseeable hazards can be

− Naturally occurring hazards;
− Unintentionally introduced hazards.
− Intentionally introduced hazards for possible economical gain
and to also include acts of terrorism.
• As the FDA has also identified that an employee’s possible
deliberate act of contamination of your products is a risk then you
need to also address this possibility and hence mitigate the risk in
your Food Defense program.

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 FSMA Section 106
Prevention of Intentional Contamination

Under Sec. 106 of the Food Safety Modernization Act the FDA
has determined that Processors and Distributors, where
applicable to the latter, need to use a HACCP approach to
determine the

• Nature of the types of hazards for which measures should be

taken to mitigate the hazard.
• To do this you need to perform a Vulnerability Assessment of
your premises, products and processes.

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 Possible Deliberate Contamination sources

• FDA has identified 3 types of deliberate acts of contamination

− Acts of Terrorism
− Disgruntled employees, consumers or competitors
− Economically motivated adulteration
(i.e. melamine). DELIBERATE
CONTAMINATION

FDA in discussions with the intelligence community has identified the inside
attacker as the greatest threat.
The following are cases were this has happened and hence support this fact.
December 1996, Berlin, Wisconsin

• The organochlorine pesticide chlordane was intentionally added to livestock

carcasses taken to a rendering plant. The contaminated carcasses were mixed
into livestock feed that was distributed to more than 4,000 farms, mostly dairy
operations, in a four-state area.
• The perpetrator then sent letters to customers notifying them of the contamination,
resulting in recalls of cheese, butter and ice cream. Product disposal cost more
than $4 million. In addition, 4,000 tons of feed and 500,000 pounds of
contaminated fat had to be destroyed. The cost to the feed producer targeted in
the incident was over $250 million. The event economically impacted the affected
farms, local feed companies, processors and others in the food supply chain.
• A competitor of the targeted facility was charged for this criminal contamination.
Apparently the competitor’s wife had had a romantic involvement with someone at
the targeted facility.
• The Wisconsin secretary of agriculture referred to the incident as an act of
domestic terrorism.

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Michigan, 2003 -- Nicotine Poisoning After
Ingestion of Contaminated Ground Beef

• On January 3, 2003, the Michigan Department of Agriculture's (MDA) Food

and Dairy Division and the U.S. Department of Agriculture (USDA) were
notified by a supermarket of a planned recall of approximately 1,700 pounds
of ground beef because of customer complaints of illness after eating the
product.
• On January 10, the supermarket notified MDA that their laboratory had
determined that the contaminant in the ground beef returned by customers
with reported illness was nicotine.
• Approximately 100 persons were affected and a person at the supermarket
was arrested and charged with deliberately poisoning the ground beef.
2012 Needles placed in sandwiches

• On July 17th a Delta flight from Amsterdam

to the USA was found to have been
catered with sandwiches that contained
sewing needles.
• Nobody was seriously injured but potential
was worrying.
• On August 3rd Air Canada flight reported a
needle in a sandwich on flight from
Victoria to Toronto.

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December 2013 Japan

• A contract employee at Aquilfoods in Japan deliberately adulterated several

frozen foods using Malathion
• 2843 people got sick
• 6.4 million packages of frozen seafood were recalled

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Possible breach of food defense leads to recall of
chicken products -- June 18, 2016.

• Minnesota’s GNP Company, based in Cold Spring, late Saturday recalled

approximately 55,608 pounds of chicken products that may be
contaminated with extraneous materials, according to the U.S. Department
of Agriculture’s Food Safety and Inspection Service (FSIS).
• The company discovered sand and black soil was turning up in some of
the products, and reported it to FSIS. No one has reported any adverse
reactions to the contaminated products. GNP Company and local law
enforcement are investigating how the sand and soil got into the chicken
products.

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 121.126. Food defense plan Requirements

You must prepare, or have prepared, and implement a written food defense plan.
The written food defense plan must include:
• (1) The written vulnerability assessment, including required explanations, to identify
significant vulnerabilities and actionable process steps as required by § 121.130(c);
• (2) The written mitigation strategies, including required explanations, as required by
§ 121.135(b);
• (3) The written procedures for the food defense monitoring of the implementation of
the mitigation strategies as required by § 121.140(a);
• (4) The written procedures for food defense corrective actions as required by
§ 121.145(a)(1); and
• (5) The written procedures for food defense verification as required by § 121.150(b).
• (c) Records. The food defense plan required by this section is a record that is
subject to the requirements of subpart D of this part.

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Step 1. Prepare a Food Defense Program

• The first step in preparing a Food Defense Program is to perform a

Vulnerability Assessment

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121.130 Vulnerability assessment requirements to identify
significant vulnerabilities and actionable process steps
You must conduct or have conducted a vulnerability assessment for each type of
food manufactured, processed, packed, or held at your facility using appropriate
methods to evaluate each point, step, or procedure in your food operation to
identify significant vulnerabilities and actionable process steps.

(a) Appropriate methods must include, at a minimum, an evaluation of:

(1) The potential public health impact (e.g., severity and scale) if a contaminant
were added;
(2) The degree of physical access to the product; and
(3) The ability of an attacker to successfully contaminate the product.
(b) Inside attacker. The assessment must consider the possibility of an inside
attacker.

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121.130 Vulnerability assessment requirements to identify
significant vulnerabilities and actionable process steps

(c) Written vulnerability assessment

• Regardless of the outcome, the vulnerability assessment must be written

and must include an explanation as to why each point, step, or procedure
either was or was not identified as an actionable process step.

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121.3. Qualified Individual

• Qualified individual means a person who has the education, training, or

experience (or a combination thereof) necessary to perform an activity
required under subpart C of this part, as appropriate to the individual’s
assigned duties.
• A qualified individual may be, but is not required to be, an employee of the
establishment.
 121.4. Qualifications of individuals who perform
activities
• (a) Applicability. You must ensure that each individual who performs activities
required under subpart C of this part is a qualified individual as that term is
defined in § 121.3.
• (b) Qualifications of individuals assigned to an actionable process step.
Each individual assigned to an actionable process step (including temporary
and seasonal personnel) or in the supervision thereof must:
– (1) Be a qualified individual as that term is defined in § 121.3—i.e., have
the appropriate education, training, or experience (or a combination
thereof) necessary to properly implement the mitigation strategy or
combination of mitigation strategies at the actionable process step; and
– (2) Receive training in food defense awareness.
121.4. Qualified Individual

A Qualified Individual must have successfully completed training for the specific
function at least equivalent to that received under a standardized curriculum
recognized as adequate by FDA or be otherwise qualified through job experience
to conduct the activities.
Job experience may qualify an individual to perform these functions if such
experience has provided an individual with knowledge at least equivalent to that
provided through the standardized curriculum.
Training Records

e) Records. Training required by paragraphs (b)(2) and (c)(2) of this

section must be documented in records, and must:
(1) Include the date of training, the type of training, and the persons
trained; and
(2) Be established and maintained in accordance with the
requirements of subpart D of this part.
Are you ready for these new Food Defense requirements?

• Yes I believe so
• Not yet, but we have started the process
• Not yet, we need to get a Food Defense Management person trained
• Not yet, Food Defense Training for our team is required

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 Foods considered harder to contaminate

Examples of where contamination would be easier to

detect hence lower risk for deliberate contamination.

• Shell Eggs
• Most Whole Produce and Vegetables
(Apples have however had needles and razor
blades placed in them)
• Game Meats (Whole or Cut but not ground or
shredded)
• Peanuts and Tree Nuts (Raw, In-Shell)
• Sugar Cane and Sugar Beets
Possible Vulnerable Areas

FDA has determined that the presence of one or more of these key
activity types at a process step (e.g., manufacturing, processing,
packing, or holding of food) indicates a significant vulnerability under
section 418 of the FD&C Act and that the food is at high risk of
intentional adulteration caused by acts of terrorism under section 420
of the FD&C Act.

• Bulk liquid receiving and loading;

• Liquid storage and handling;
• Secondary ingredient handling; and
• Mixing and similar activities.

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Ingredient and product handling vulnerabilities

• Ingredient weighing rooms

• Pre-mix areas
• Adding rework back to products
• Returned products
Mixing and similar exposed product areas

• Mix kettles
• Blending operations
• Grinding operations
• Open processing points
Mixing and similar exposed product areas
 Other possible vulnerable areas

• Unsealed trailers, railcars, tankers allowing access to tamper with

products.
• Unlocked doors into your facility allowing easy access to products.
• Unlocked windows on street level allowing access to your facility.
• Inlets into building for receiving liquids including water, if latter is from
an unprotected well.
Definition of an Actionable Process Step

• Actionable process step means a point, step, or procedure in a food

process where a significant vulnerability exists and at which mitigation
strategies can be applied and are essential to significantly minimize or
prevent the significant vulnerability.
Step 2. Actionable Process steps

A Facility can identify their actionable process steps using one of two
procedures.
• The FDA-identified key activity types (CARVER and Shock), OR
• By conducting their own facility-specific vulnerability assessments

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FDA CARVER Program

Criticality

Accessibility

Recuperability

Vulnerability

Effect

Recognizability
FDA SHOCK Program

SHOCK

Added to CARVER program to assess the

combined health, economic and
psychological impacts of an attack within the
food industry.
121.135. Mitigation strategies for actionable process
steps

(a) You must identify and implement mitigation strategies at each

actionable process step to provide assurances that the significant
vulnerability at each step will be significantly minimized or prevented
and the food manufactured, processed, packed, or held by your facility
will not be adulterated under section 402 of the Federal Food, Drug,
and Cosmetic Act.
For each mitigation strategy implemented at each actionable process
step, you must include a written explanation of how the mitigation
strategy sufficiently minimizes or prevents the significant vulnerability
associated with the actionable process step.

(b) Mitigation strategies and accompanying explanations must be written.

Possible Focused Mitigation Strategies–Bulk
Products
• Establish check-in and shipment verification procedures, such as
checking seals and associated documentation
• Restrict movement of delivery drivers if allowed into the facility
• Secure transfer hoses in locked cabinets
• Install locks on tanks inside and outside
• Restrict access to bulk tanks to only key individuals
• Cameras

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Suggested Focused Mitigation Strategies – General

• Always ensure a clear line of sight to actionable process steps

(e.g., store stacks of pallets in less obstructive location).
• Reduce staging time of ingredients and in-process products including
rework.
• Avoid employees working in rooms on their own with exposed
products/ingredients.
• Retrofit equipment to reduce accessibility
(e.g., install lids on open mixers).

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Possible Focused Mitigation Strategies –In-process
Products

• Supervisors
• Cameras
• Restricting employee flow
• Locked doors from outside
• Restricted Visitor movement
• Equipment covers
• Peer observations

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Step 3. Implementation of Mitigation Strategies
(121.138)
Mitigation strategies required under § 121.135 are subject to the following
mitigation strategies management components as appropriate to ensure
the proper implementation of the mitigation strategies, taking into account
the nature of each such mitigation strategy and its role in the facility’s food
defense system:

(a) Food defense monitoring in accordance with § 121.140;

(b) Food defense corrective actions in accordance with § 121.145; and
(c) Food defense verification in accordance with § 121.150.

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Step 4. Monitoring of Mitigation Strategies (121.140)

As appropriate to the nature of the mitigation strategy and its role in the
facility’s food defense system:
• (a) Written procedures.
You must establish and implement written procedures, including the
frequency with which they are to be performed, for food defense
monitoring of the mitigation strategies.

• (b) Food defense monitoring.

You must monitor the mitigation strategies with adequate frequency to
provide assurances that they are consistently performed.

• (c) Records—
(1) Requirement to document food defense monitoring.
You must document the monitoring of mitigation strategies in
accordance with this section in records that are subject to verification in
accordance with § 121.150(a)(1) and records review in accordance with
§ 121.150(a)(3)(i).
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Step 4. Monitoring of Mitigation Strategies (121.140)

• (2) Exception records.

Records may be affirmative records demonstrating the mitigation

strategy is functioning as intended.
Exception records demonstrating the mitigation strategy is not
functioning as intended may be adequate in some circumstances.

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Step 5. Corrective Actions (121.145)

(a) Food defense corrective action procedures.

As appropriate to the nature of the actionable process step and the nature
of the mitigation strategy:

• (1) You must establish and implement written food defense corrective
action procedures that must be taken if mitigation strategies are not
properly implemented.
• (2) The food defense corrective action procedures must describe the
steps to be taken to ensure that:
– (i) Appropriate action is taken to identify and correct a problem that
has occurred with implementation of a mitigation strategy; and
– (ii) Appropriate action is taken, when necessary, to reduce the
likelihood that the problem will recur.

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Step 5. Corrective Actions Records (121.145)

(b) Records. All food defense corrective actions taken in accordance with
this section must be documented in records that are subject to food
defense verification in accordance with § 121.150(a)(2) and records
review in accordance with § 121.150(a)(3)(i).

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Step 6. Verification Procedures (121.150)

(a) Food defense verification activities.

Food defense verification activities must include, as appropriate to the

nature of the mitigation strategy and its role in the facility’s food defense
system:

• (1) Verification that food defense monitoring is being conducted as

required by § 121.138 (and in accordance with § 121.140);
• (2) Verification that appropriate decisions about food defense corrective
actions are being made as required by § 121.138 (and in accordance
with § 121.145);

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Step 6. Verification Procedures (121.150)

(3) Verification that mitigation strategies are properly implemented and are
significantly minimizing or preventing the significant vulnerabilities. To do
so, you must conduct activities that include the following, as appropriate to
the facility, the food, and the nature of the mitigation strategy and its role in
the facility’s food defense system:

• (i) Review of the food defense monitoring and food defense corrective
actions records within appropriate timeframes to ensure that the
records are complete, the activities reflected in the records occurred in
accordance with the food defense plan, the mitigation strategies are
properly implemented, and appropriate decisions were made about
food defense corrective actions; and
• (ii) Other activities appropriate for verification of proper implementation
of mitigation strategies; and

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Step 6. Verification Procedures (121.150)

(4) Verification of reanalysis in accordance with § 121.157. (b) Written

procedures.

You must establish and implement written procedures, including the

frequency for which they are to be performed, for verification activities
conducted according to § 121.150(a)(3)(ii).

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121.305 General requirements applying to records

Records must:
a) Be kept as original records, true copies (such as photocopies,
pictures, scanned copies, microfilm, microfiche, or other accurate
reproductions of the original records), or electronic records;
b) Contain the actual values and observations obtained during food
defense monitoring;
c) Be accurate, indelible, and legible;
d) Be created concurrently with performance of the activity documented;

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 121.305 General requirements applying to records

(e) Be as detailed as necessary to provide history of work performed; and

(f) Include:
– (1) Information adequate to identify the facility (e.g., the name, and
when necessary, the location of the facility);
– (2) The date and, when appropriate, the time of the activity
documented;
– (3) The signature or initials of the person performing the activity; and
– (4) Where appropriate, the identity of the product and the lot code, if
any.

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Steps to implement an effective Food Defense Program

• Ensure that personnel and supervisors assigned to actionable

process steps receive appropriate training in food defense awareness
and their respective responsibilities in implementing focused
mitigation strategies.
• Establish and maintain certain records, including
– the written food defense plan;
– written identification of actionable process steps and the
assessment leading to that identification;
– written focused mitigation strategies;
– written procedures for monitoring and corrective actions;
– verification;
– documentation related to training of personnel.

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 Steps to implement an effective Food Defense
Program
1. Identify and implement focused mitigation strategies at each actionable
process step to provide assurances that the significant vulnerability at each
step will be significantly minimized or prevented and that the food
manufactured, processed, packed, or held by such facility will not be
adulterated
2. Establish and implement procedures, including the frequency with which they
are to be performed, for monitoring the focused mitigation strategies.
3. Establish and implement corrective action procedures that must be taken if
focused mitigation strategies are not properly implemented.
4. Verify that monitoring is being conducted and appropriate decisions about
corrective actions are being made; verify that the focused mitigation
strategies are consistently implemented and are effectively and significantly
minimizing or preventing the significant vulnerabilities; and conduct a
reanalysis of the food defense plan.

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 What is your biggest challenge?

• Shortage of time
• Our culture is to trust people
• We feel these requirements are intrusive

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 § 121.157 . Reanalysis

a) You must conduct a reanalysis of the food defense plan, as a whole at

least once every 3 years;

b) You must conduct a reanalysis of the food defense plan as a whole, or

the applicable portion of the food defense plan:
(1) Whenever a significant change made in the activities conducted at
your facility creates a reasonable potential for a new vulnerability or a
significant increase in a previously identified vulnerability;

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§ 121.157 . Reanalysis

(2) Whenever you become aware of new information about potential

vulnerabilities associated with the food operation or facility;

(3) Whenever you find that a mitigation strategy, a combination of

mitigation strategies, or the food defense plan as a whole is not
properly implemented; and

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§ 121.157 . Reanalysis

(4) Whenever FDA requires reanalysis to respond to new

vulnerabilities, credible threats to the food supply, and developments
in scientific understanding including, as appropriate, results from the
Department of Homeland Security biological, chemical, radiological, or
other terrorism risk assessment.

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 § 121.157 . Reanalysis

(c) You must complete such reanalysis required by paragraphs (a) and (b)
of this section and implement any additional mitigation strategies needed
to address the significant vulnerabilities identified, if any:
(1) Before any change in activities (including any change in mitigation
strategy) at the facility is operative;
(2) When necessary within 90-calendar days after production; and
(3) Within a reasonable timeframe, providing a written justification is
prepared for a timeframe that exceeds 90 days after production of the
applicable food first begins.

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§ 121.157 . Reanalysis

(d) You must revise the written food defense plan if a significant
change in the activities conducted at your facility creates a reasonable
potential for a new vulnerability or a significant increase in a previously
identified vulnerability or document the basis for the conclusion that no
revisions are needed.

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§ 121.315 Requirements for record retention

(a)
(1) All records required by this part must be retained at the
facility for at least 2 years after the date they were prepared.
(2) Records that a facility relies on during the 3-year period
preceding the applicable calendar year to support its status as
exempt as a very small business must be retained at the facility as
long as necessary to support the status of a facility as a very small
business during the applicable calendar year.
(b) The food defense plan must be retained for at least 2 years after its
use is discontinued.

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§ 121.315 Requirements for record retention

(c) Except for the food defense plan, offsite storage of records is
permitted if such records can be retrieved and provided onsite within 24
hours of request for official review. The food defense plan must remain
onsite.
Electronic records are considered to be onsite if they are accessible
from an onsite location.
(d) If the facility is closed for a prolonged period, the food defense plan
may be transferred to some other reasonably accessible location but
must be returned to the facility within 24 hours for official review upon
request.

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§ 121.310 Additional requirements applying to the food
defense plan

The owner, operator, or agent in charge of the facility must sign and
date the food defense plan:

• (a) Upon initial completion; and

• (b) Upon any modification.

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 Effective and Compliance Dates

• Effective date is July 26, 2016

• Compliance dates are:
– Large businesses have 3 years
– Small businesses (<500 FTE Employees) have 4 years
– Very small businesses (<$10 million sales) have 5 years to prove
they are exempt

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Dr. Bob Strong
Senior Consultant
SAI Global - Americas
Mobile 513-349-5398
Email [email protected]

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